Medicines in Development for Cancer
Transcription
Medicines in Development for Cancer
2012 Report Medicines in Development Cancer presented by america’s biopharmaceutical research companies More Than 900 Medicines and Vaccines in Clinical Testing Offer New Hope in the Fight Against Cancer Medicines in Development for Selected Cancer Types More Than 1.6 million New Cases of Cancer 121 Are Expected This Year 117 111 94 67 66 Few things cause more fear and apprehension than a cancer diagnosis. But today—because of early detection and a steady stream of new and improved treatments—cancer increasingly can be managed and even beaten. But patients and their families are looking for more and better treatments, and America’s biopharmaceutical research companies are responding. er r nc Ca Sk in an ce a Pr os tat eC ph nc Ly m Ca om er r ce ng Lu nc cta Ca re ea st Co lo Br lC an er Biopharmaceutical researchers are now working on 981 medicines for cancer. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways. Researchers’ deep commitment to patients and advancing science is at the core of the remarkable progress made in fighting cancer. In recent years we have seen significant declines in cancer deaths. The number of cancer survivors living in the United States has increased from 3 million in 1971 to nearly 12 million in 2008. The increase in survivors is attributed in large measure to earlier diagnosis and detection and better treatments and follow-up care. America’s biopharmaceutical research companies are working on many new cutting-edge approaches to fight cancer. They include: •A medicine that interferes with the metabolism of cancer cells by depriving them of the energy provided by glucose. •A medicine for acute myeloid leukemia (AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers. •A therapy that uses nanotechnology to target the delivery of medicines to cancer cells, potentially overcoming some limitations of existing treatments. Despite recent progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart disease. In 2012, some 577,190 Americans are expected to die of cancer—more than 1,500 people a day. The hundreds of new medicines to treat cancer now being developed are our best hope for lessening the burden of cancer to patients, their families and society. Medicines in Development for Cancer Medicines in Development for Cancer* Bladder Cancer 9 Brain Cancer 62 Breast Cancer Cervical Cancer 111 8 Colorectal Cancer 66 Head/Neck Cancer 25 Kidney Cancer 35 Leukemia 120 Liver Cancer 36 Lung Cancer 121 Lymphoma 117 Multiple Myeloma 57 Ovarian Cancer 63 Pancreatic Cancer 58 Prostate Cancer Sarcoma 94 21 Skin Cancer 67 Solid Tumors 280 Stomach Cancer 23 Cancer-Related Conditions 38 Other Cancers 102 Unspecified Cancer 72 * Some medicines are listed in more than one category. Bladder Cancer Product Name Sponsor Indication Development Status* Abraxane® albumin-bound paclitaxel Celgene Summit, NJ second-line bladder cancer (see also breast, lung, ovarian, pancreatic, skin) Phase II (908) 673-9000 AEZS-108 AEterna Zentaris Basking Ridge, NJ (see also ovarian, prostate, other) Phase II (908) 626-5428 BC-819 (gene therapy) BioCancell Therapeutics Jerusalem, Israel (see also ovarian, pancreatic) Phase II www.biocancell.com EN3488 (mycobacterium cell wall-DNA complex) Endo Pharmaceuticals Chadds Ford, PA non-muscle invasive bladder cancer (Fast Track) Phase III (610) 558-9800 **For more information about a specific medicine in this report, please call the telephone number listed. 2 Medicines in Development Cancer 2012 Medicines in Development for Cancer Bladder Cance Product Name Sponsor Indication Development Status EOquin® apaziquone Allergan Irvine, CA Spectrum Pharmaceuticals Irvine, CA non-invasive bladder cancer (Fast Track) Phase III (949) 788-6700 Folotyn® pralatrexate (Orphan Drug) Allos Therapeutics Westminster, CO (see also breast, lung, lymphoma) Phase II (303) 426-6262 icrucumab (LY3012212/IMC-18F1) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ (see also breast, colorectal) Phase II (800) 545-5979 tesetaxel Genta Berkeley Heights, NJ second-line bladder cancer (see also breast, prostate, skin, stomach) Phase II (908) 286-9800 VB4-845 Viventia Biotechnologies Mississauga, Canada (see also head/neck) Phase II (905) 362-2973 Product Name Sponsor Indication Development Status 8H9 I-131 mAb United Therapeutics Silver Spring, MD (see also sarcoma, other) Phase I (301) 608-9292 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL (see also breast, colorectal, lung, lymphoma, ovarian, prostate, skin, other) Phase I (847) 937-6100 AC480 (pan-HER inhibitor) Ambit Biosciences San Diego, CA glioma (see also breast, lung) Phase I (858) 334-2100 AEE788 Novartis Pharmaceuticals East Hanover, NJ glioblastoma Phase I/II (888) 669-6682 afatinib (BIBW2992) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT glioblastoma (see also breast, head/neck, lung) Phase I/II (800) 243-0127 APN301 (ch14.18 mAb/interleukin-2 fusion protein) Apeiron Biologics Vienna, Austria neuroblastoma in children (see also skin) Phase II completed www.apeiron-biologics.com Brain Cancer Medicines in Development Cancer 2012 3 Medicines in Development for Cancer Brain Cancer Product Name Sponsor Indication Development Status AR-67 Arno Therapeutics Flemington, NJ glioblastoma (see also leukemia, solid tumors) Phase II (862) 703-7170 ARC-100 Archer Biosciences New York, NY glioblastoma (recurrent) (see also breast, prostate, skin) -------------------------------------------------neuroblastoma (combination therapy) -------------------------------------------------medulloblastoma (combination therapy) Phase II (646) 747-9090 ------------------------------------------Phase I/II (646) 747-9090 ------------------------------------------Phase I (646) 747-9090 AT-101 (oral pan Bcl-2 inhibitor) Ascenta Therapeutics Malvern, PA glioblastoma (see also leukemia, lung, lymphoma, prostate, stomach) Phase II (610) 408-0301 Avastin® bevacizumab Genentech South San Francisco, CA first-line glioblastoma multiforme (see also breast, colorectal, lung, ovarian, other) Phase III (800) 626-3553 Azedra™ metaiodobenzylguanidine I-131 (Orphan Drug) Molecular Insights Pharmaceuticals Cambridge, MA neuroblastoma (pediatric) (Fast Track), paraganglioma, pheochromocytoma (Fast Track) Phase II (617) 492-5554 bafetinib CytRx Los Angeles, CA second-line brain cancer (see also leukemia, prostate) Phase I (310) 826-5648 BKM120 (PI3K inhibitor) Novartis Pharmaceuticals East Hanover, NJ glioblastoma (see also breast, lung, other) Phase I/II (888) 669-6682 ch14.18 mAb (Orphan Drug) United Therapeutics Silver Spring, MD neuroblastoma (children) Phase III (301) 608-9292 cilengitide (Orphan Drug) EMD Serono Rockland, MA newly-diagnosed glioblastoma (combination therapy) (see also prostate) Phase III (800) 283-8088 cintredekin besudotox (Orphan Drug) INSYS Therapeutics Phoenix, AZ glioma (adolescents and children) (Fast Track) Phase I (602) 910-2617 Cotara® monoclonal antibody TNT-1 (Orphan Drug) Peregrine Pharmaceuticals Tustin, CA recurrent glioblastoma (Fast Track) Phase II (714) 508-6000 CPP-1X (eflornithine) Cancer Prevention Pharmaceuticals Tucson, AZ neuroblastoma Phase I (520) 908-7774 4 Medicines in Development Cancer 2012 Medicines in Development for Cancer Brain Cancer Product Name Sponsor Indication Development Status crenolanib (CP-868-596) AROG Pharmaceuticals Dallas, TX glioma (adults) (see also stomach) -------------------------------------------------glioma (pediatric) Phase II (214) 594-0002 ------------------------------------------Phase I (214) 594-0002 DCVax®-Brain brain cancer vaccine (Orphan Drug) Northwest Biotherapeutics Bethesda, MD glioblastoma Phase II (240) 497-9024 E7050 Eisai Woodcliff Lake, NJ second-line glioblastoma (see also head/neck, liver, skin, solid tumors, stomach) Phase I/II (888) 422-4743 E7080 (lenvatinib) Eisai Woodcliff Lake, NJ glioma (see also skin, other) Phase II (888) 422-4743 EPO-806 (patupilone) Novartis Pharmaceuticals East Hanover, NJ brain metastases from lung cancer (see also prostate) Phase II (888) 669-6682 G-100 prophage cancer vaccine (vitespen) (Orphan Drug) Agenus Lexington, MA newly-diagnosed glioma Phase II (781) 674-4400 G-200 prophage cancer vaccine (vitespen) (Orphan Drug) Agenus Lexington, MA recurrent glioma Phase II (781) 674-4400 GliAtak™ gene therapy (Orphan Drug) Advantagene Auburndale, MA glioma Phase II (617) 916-5445 ------------------------------------------Phase I (617) 916-5445 GMB-Vax dendritic cell cancer vaccine Activartis Biotech Vienna, Austria first-line glioblastoma Phase II www.activartis.com GRN1005 (LRP directed peptide-drug conjugate) Geron Menlo Park, CA brain metastases Phase II (650) 473-7700 ------------------------------------------Phase I completed (650) 473-7700 GSK2118436 (BRaf protein kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC brain metastases from melanoma (see also lung, skin) Phase II (888) 825-5249 Hycamtin® topotecan GlaxoSmithKline Rsch. Triangle Park, NC metastatic brain cancer Phase III (888) 825-5249 Medicines in Development Cancer 2012 -------------------------------------------------brain cancer (children) -------------------------------------------------glioma 5 Medicines in Development for Cancer Brain Cancer Product Name Sponsor Indication Development Status ICT-107 (dendritic cell vaccine) (Orphan Drug) ImmunoCellular Therapeutics Woodland Hills, CA glioblastoma Phase II (818) 992-2907 Levulan® PDT aminolevulinic acid DUSA Pharmaceuticals Wilmington, MA lonafarnib Merck Whitehouse Station, NJ glioblastoma Phase I (800) 672-6372 Lucanix® belagenpumatucel-L NovaRx San Diego, CA glioma (see also lung) Phase I (858) 522-8600 macitentan Actelion Pharmaceuticals US South San Francisco, CA glioblastoma (combination therapy) Phase I (650) 624-6900 MEDI-575 (anti-PDGFR-alpha mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD glioblastoma (see also lung) Phase II (800) 236-9933 (301) 398-0000 mibefradil (T-type calcium channel inhibitor) (Orphan Drug) Tau Therapeutics Charlottesville, VA glioblastoma Phase I (434) 974-6969 motexafin gadolinium Pharmacyclics Sunnyvale, CA glioblastoma (combination therapy) Phase II (408) 774-0330 nimotuzumab (Orphan Drug) YM Biosciences USA Lehigh Valley, PA metastatic brain cancer, recurrent glioma (pediatric) (see also breast, prostate) Phase II (610) 560-0600 olaratumab (LY3012207) Eli Lilly Indianapolis, IN ImClone Systems Bridgewater, NJ glioblastoma (see also ovarian) Phase II (800) 545-5979 Opaxio™ paclitaxel poliglumex Cell Therapeutics Seattle, WA glioma, glioblastoma (see also lung, ovarian, stomach, other) Phase II (800) 215-2355 perifosine AEterna Zentaris Basking Ridge, NJ refractory metastatic glioma (see also colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach) Phase II (908) 626-5428 6 Phase II (978) 657-7500 Medicines in Development Cancer 2012 Medicines in Development for Cancer Brain Cancer Product Name Sponsor Indication Development Status PLX3397 (CSF-1R kinase inhibitor) Plexxikon Berkeley, CA recurrent glioblastoma (see also leukemia, lymphoma, solid tumors) Phase II (510) 647-4000 Poly-ICLC (Orphan Drug) Oncovir Washington, DC anaplastic astrocytoma (adolescents and children), glioblastoma (adolescents and children) Phase II www.oncovir.com PX-866 Oncothyreon Seattle, WA second-line glioblastoma (see also head/neck, lung, prostate) Phase II (206) 801-2100 Reolysin® reovirus Oncolytics Biotech Calgary, Canada glioma (see also colorectal, head/neck, lung, ovarian, pancreatic, sarcoma, skin, solid tumors) Phase I/II (403) 670-7377 rindopepimut (Orphan Drug) Celldex Therapeutics Needham, MA first-line glioblastoma (Fast Track) -------------------------------------------------second-line glioblastoma (Fast Track) Phase III (781) 433-0771 ------------------------------------------Phase II (781) 433-0771 SB-313-xTZ Sangamo Biosciences Richmond, CA glioblastoma Phase I (510) 970-6000 SBG Biotec Pharmacon Tromsø, Norway neuroblastoma (pediatric) Phase I/II completed www.biotec.no SL-701 (brain cancer vaccine) Stemline Therapeutics New York, NY glioma (adults) Phase I/II (212) 831-1111 ------------------------------------------Phase I/II (212) 831-1111 SPRYCEL® dasatinib Bristol-Myers Squibb Princeton, NJ glioblastoma (see also breast, pancreatic, prostate, other) in clinical trials (800) 332-2056 Tarceva® erlotinib (Orphan Drug) Genentech South San Francisco, CA OSI Pharmaceuticals Farmingdale, NY late-stage brain metastases, recurrent ependymoma (children), glioblastoma (see also breast, head/neck, leukemia, liver, lung, other) Phase II (800) 626-3553 (631) 962-0600 terameprocol Erimos Pharmaceuticals Houston, TX glioma (intravenous) (see also cervical, head/neck, solid tumors, other) Phase I/II (713) 541-2000 TGF-ß R1 inhibitor (LY2157299) Eli Lilly Indianapolis, IN (see also liver) Phase II (800) 545-5979 Medicines in Development Cancer 2012 -------------------------------------------------glioma (children) 7 Medicines in Development for Cancer Brain Cancer Product Name Sponsor Indication Development Status TH-302 Threshold Pharmaceuticals South San Francisco, CA astrocytoma (see also leukemia, multiple myeloma, pancreatic, sarcoma) Phase II (650) 474-8200 Toca 511/Toca FC (cytosine deaminase gene therapy) Tocagen San Diego, CA glioblastoma Phase I/II (858) 412-8400 trans-sodium crocetinate (TSC) (Orphan Drug) Diffusion Pharmaceuticals Charlottesville, VA gliobastoma Phase I/II (434) 220-0718 TVI-Brain-1 (cellular immunotherapy vaccine) TVAX Biomedical Lenexa, KS glioma Phase II (913) 492-2221 VAL-083 Del Mar Pharmaceuticals Vancouver, Canada grade IV malignant glioma Phase I/II (604) 629-5989 VB-111 VBL Therapeutics Or Yehuda, Israel glioblastoma (see also other) Phase I/II www.vblrx.com Xeloda® capecitabine Genentech South San Francisco, CA newly-diagnosed glioma (adolescents and children) (see also colorectal, liver, stomach) Phase I (800) 626-3553 Zelboraf® vemurafenib Genentech South San Francisco, CA Plexxikon Berkeley, CA brain metastases (see also colorectal, other) Phase II (800) 626-3553 Product Name Sponsor Indication Development Status 18F-fluorothymidine Merck Whitehouse Station, NJ breast cancer (diagnosis) Phase II (800) 672-6372 Abraxane® albumin-bound paclitaxel Celgene Summit, NJ first-line metastatic breast cancer (see also bladder, lung, ovarian, pancreatic, skin) Phase II (908) 673-9000 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL (see also brain, colorectal, lung, lymphoma, ovarian, prostate, skin, other) Phase II (847) 937-6100 AC480 (pan-HER inhibitor) Ambit Biosciences San Diego, CA (see also brain, lung) Phase I (858) 334-2100 Breast Cancer 8 Medicines in Development Cancer 2012 Medicines in Development for Cancer Breast Cancer Product Name Sponsor acolbifene (4th-generation SERM) EndoCeutics Quebec, Canada AE37 peptide vaccine Antigen Express Worcester, MA (see also ovarian) Phase II (508) 852-8783 afatinib (BIBW2992) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT second-line metastatic breast cancer (see also brain, head/neck, lung) -------------------------------------------------first-line breast cancer Phase III (800) 243-0127 ------------------------------------------Phase II (800) 243-0127 afimoxifene ASCEND Therapeutics Herndon, VA breast cancer (prevention) Phase II (703) 471-4744 Afinitor® everolimus Novartis Pharmaceuticals East Hanover, NJ HER2-positive breast cancer (see also kidney, lymphoma) Phase III (888) 669-6682 AFP464 Kirax Bonita Springs, FL amrubicin Celgene Summit, NJ late-stage breast cancer (see also lung) Phase I/II (908) 673-9000 ARC-100 Archer Biosciences New York, NY (see also brain, prostate, skin) Phase II (646) 747-9090 ARRY-380 (HER2 inhibitor) Array BioPharma Boulder, CO AUY922 (Hsp90 inhibitor) Novartis Pharmaceuticals East Hanover, NJ Medicines in Development Cancer 2012 Indication Development Status Phase II (418) 653-0033 Phase II (239) 444-5400 Phase I (877) 633-2436 breast cancer (monotherapy) (see also colorectal, lung, multiple myeloma, stomach) -------------------------------------------------breast cancer (combination therapy) Phase II (888) 669-6682 ------------------------------------------Phase I/II (888) 669-6682 9 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status Avastin® bevacizumab Genentech South San Francisco, CA adjuvant HER2-negative breast cancer, adjuvant HER2-positive breast cancer, adjuvant triple negative breast cancer (see also brain, colorectal, lung, ovarian, other) Phase III (800) 626-3553 AZD8931 (erbB kinase inhibitor) AstraZeneca Wilmington, DE advanced breast cancer (combination therapy) (see also solid tumors) Phase II (800) 236-9933 BAY 86-5044 (lonaprisan) Bayer HealthCare Pharmaceuticals Wayne, NJ metastatic breast cancer Phase II completed (888) 842-2937 BIIB 2024 Biogen Idec Cambridge, MA (see also stomach) Phase II completed (617) 679-2000 BKM120 (PI3K inhibitor) Novartis Pharmaceuticals East Hanover, NJ second-line breast cancer (see also brain, lung, other) Phase I/II (888) 669-6682 breast cancer vaccine (dendritic cell vaccine) Quantum Immunologics Tampa, FL brostallicin Cell Therapeutics Seattle, WA triple-negative breast cancer Phase I (800) 215-2355 BTSCAN Molecular Targeting Technologies West Chester, PA breast cancer (diagnosis) Phase I (610) 738-7938 BZL-101 Bionovo Emeryville, CA cabozantinib (XL184) Exelixis South San Francisco, CA (see also kidney, lung, ovarian, prostate, other) Phase II (650) 837-7000 cancer vaccine MabVax Therapeutics San Diego, CA (see also sarcoma) Phase I (858) 259-9405 CDX-011 (glembatumumab vedotin) Celldex Therapeutics Needham, MA breast cancer (Fast Track) (see also skin) Phase II (781) 433-0771 CV-301 (cancer vaccine) BN ImmunoTherapeutics Mountain View, CA metastatic breast cancer Phase II (650) 681-4660 D-1MT NewLink Genetics Ames, IA second-line metastatic breast cancer (see also solid tumors) Phase I/II (515) 296-5555 10 Phase I/II (866) 213-4594 Phase I (510) 601-2000 Medicines in Development Cancer 2012 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status dalotuzumab (MK-0646) Merck Whitehouse Station, NJ second-line breast cancer (combination therapy) (see also lung, pancreatic, other) -------------------------------------------------first-line breast cancer Phase II (800) 672-6372 ------------------------------------------Phase I (800) 672-6372 DPX-0907 Immunovaccine Halifax, Canada (see also ovarian, prostate) Phase I (902) 492-1819 eniluracil Adherex Technologies Rsch. Triangle Park, NC metastatic breast cancer (combination therapy) Phase II (919) 636-4530 entinostat Syndax Pharmaceuticals Waltham, MA (see also colorectal, kidney, leukemia, lung, lymphoma) Phase II (781) 419-1400 etirinotecan pegol (NKTR-102) Nektar Therapeutics San Francisco, CA metastatic breast cancer (see also colorectal, ovarian, solid tumors) Phase III (855) 482-6587 EZN-2208 (PEG-SN38, firtecan pegol) Enzon Pharmaceuticals Piscataway, NJ metastatic breast cancer (see also colorectal, solid tumors) Phase II (973) 980-4500 Faslodex® fulvestrant AstraZeneca Wilmington, DE first-line advanced breast cancer Phase III (800) 236-9933 folate binding protein (E39) vaccine Galena Biopharma Lake Oswego, OR (see also ovarian, other) Phase I (855) 855-4253 Folotyn® pralatrexate Allos Therapeutics Westminster, CO (see also bladder, lung, lymphoma) Phase II (303) 426-6262 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA (see also colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach) Phase II (781) 274-8200 ganitumab (AMG 479) Amgen Thousand Oaks, CA combination therapy (see also colorectal, lung, pancreatic, sarcoma) Phase II (800) 772-6436 GDC-0980 (PI3 kinase/mTOR dual inhibitor) Genentech South San Francisco, CA hormone receptor-positive breast cancer (see also lymphoma, solid tumors) Phase II (800) 626-3553 GSK2302024A (WT1 antigen-specific cancer immunotherapeutic) GlaxoSmithKline Rsch. Triangle Park, NC neoadjuvant breast cancer Phase I/II (888) 825-5249 GVAX® Breast cancer vaccine BioSante Pharmaceuticals Lincolnshire, IL Medicines in Development Cancer 2012 Phase I (847) 478-0500 11 Medicines in Development for Cancer Breast Cancer Product Name Sponsor HER2 antigen-specific cancer immunotherapeutic GlaxoSmithKline Rsch. Triangle Park, NC icrucumab (LY3012212/IMC-18F1) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ metastatic breast cancer (see also bladder, colorectal) Phase II (800) 545-5979 imetelstat Geron Menlo Park, CA metastatic breast cancer (combination therapy) (see also leukemia, lung, multiple myeloma) Phase II (650) 473-7700 IMT-1012 immunotherapeutic vaccine Immunotope Doylestown, PA (see also ovarian) Phase I (215) 253-4180 indibulin (ZIO-301) ZIOPHARM Oncology New York, NY late-stage breast cancer Phase I/II (646) 214-0700 iniparib (BSI-201) Sanofi US Bridgewater, NJ neoadjuvant breast cancer (see also lung, ovarian) Phase II (800) 981-2491 KW-2450 Kyowa Hakko Kirin Pharma Princeton, NJ first-line breast cancer, second-line breast cancer Phase I/II (609) 919-1100 LFA102 (anti-prolactin receptor antibody) Novartis Pharmaceuticals East Hanover, NJ XOMA Berkeley, CA (see also prostate) Phase I (888) 669-6682 LGK974 (WNT signaling pathway inhibitor) Novartis Pharmaceuticals East Hanover, NJ (see also skin) Phase I (888) 669-6682 linifanib Abbott Laboratories Abbott Park, IL breast cancer (combination therapy) (see also colorectal, kidney, liver, lung) Phase II (847) 937-6100 liposome encapsulated paclitaxel (LEP-ETU) Insys Therapeutics Phoenix, AZ litronesib (LY2523355) Eli Lilly Indianapolis, IN metastatic breast cancer (see also lung) Phase II (800) 545-5979 LOR-2040 Lorus Therapeutics Toronto, Canada metastatic breast cancer (see also colorectal, kidney, leukemia, prostate) Phase II (416) 798-1200 Lymphoseek® Tc-99m tilmanocept Navidea Pharmaceuticals Dublin, OH breast cancer (diagnosis) (see also head/neck, skin) application submitted (614) 793-7500 12 Indication Development Status Phase II (888) 825-5249 Phase II (602) 910-2617 Medicines in Development Cancer 2012 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status maraciclatide GE Healthcare Waukesha, WI breast cancer (diagnosis) in clinical trials www.gehealthcare.com MK-0752 (notch signaling pathway inhibitor) Merck Whitehouse Station, NJ early-stage breast cancer, late-stage breast cancer (see also other) Phase I (800) 672-6372 MK-2206 (c-akt inhibitor) Merck Whitehouse Station, NJ HER2-positive breast cancer (see also other) Phase I (800) 672-6372 MM-111 Merrimack Pharmaceuticals Cambridge, MA breast cancer (combination therapy) Phase I/II (617) 441-1000 MM-302 (anti-HER2 antibody doxorubicin conjugate) Merrimack Pharmaceuticals Cambridge, MA motesanib Amgen Thousand Oaks, CA MVA-BN® HER2 (HER-2/neu-based MVA vaccine) BN ImmunoTherapeutics Mountain View, CA Myocet™ doxorubicin liposomal Sopherion Therapeutics Princeton, NJ first-line breast cancer (combination therapy) (Fast Track) Phase III (609) 986-2020 NeuVax™ cancer vaccine E75 Galena Biopharma Lake Oswego, OR early-stage breast cancer (prevention of relapse) (see also prostate) Phase III (855) 855-4253 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ (see also colorectal, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other) Phase III (888) 842-2937 nimotuzumab YM Biosciences USA Lehigh Valley, PA (see also brain, prostate) Phase I (610) 560-0600 NK-012 Nippon Kayaku Tokyo, Japan (see also lung) Phase II www.nipponkayaku.co.jp OBP-301 Oncolys Biopharma Tokyo, Japan (see also head/neck, liver, lung) Phase I www.oncolys.com OGX-427 OncoGenex Pharmaceuticals Bothell, WA (see also lung, ovarian) Phase I (425) 686-1500 Medicines in Development Cancer 2012 Phase I (617) 441-1000 (see also colorectal, lung, other) Phase I/II (800) 772-6436 Phase I (650) 681-4660 13 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status onartuzumab Genentech South San Francisco, CA metastatic breast cancer (combination therapy) (see also colorectal, lung) Phase II (800) 626-3553 OPT-822/OPT-821 Optimer Biotechnology San Diego, CA PB-272 (neratinib) Puma Biotechnology Los Angeles, CA second-line breast cancer, neoadjuvant breast cancer Phase II (424) 248-6500 pertuzumab Genentech South San Francisco, CA first-line metastatic breast cancer application submitted (800) 626-3553 ------------------------------------------Phase II (800) 626-3553 pertuzumab companion diagnostic (HER2 FISH pharmDx™) Dako Glostrup, Denmark Genentech South San Francisco, CA breast cancer (diagnostic) Phase III www.dako.com (800) 626-3553 pertuzumab companion diagnostic (HercepTest™) Dako Glostrup, Denmark Genentech South San Francisco, CA breast cancer (diagnosis) Phase III www.dako.com (800) 626-3553 pixantrone Cell Therapeutics Seattle, WA breast cancer (Fast Track) (see also lymphoma) Phase II (800) 215-2355 PTC299 PTC Therapeutics South Plainfield, NJ (see also solid tumors, other) Phase I/II (908) 222-7000 Quinamed® amonafide Cephalon Frazer, PA (see also ovarian, prostate) Phase II (610) 344-0200 ramucirumab (IMC-1121B) Eli Lilly Indianapolis, IN ImClone Systems Bridgewater, NJ metastatic breast cancer (see also colorectal, stomach) Phase III (800) 545-5979 Reximmune-C® personalized cancer vaccine Epeius Biotechnologies San Marino, CA Rexin-G® Epeius Biotechnologies San Marino, CA 14 Phase II/III (858) 909-0736 -------------------------------------------------second-line late-stage breast cancer Phase I/II (626) 441-6695 metastatic breast cancer (see also pancreatic, sarcoma) Phase I/II (626) 441-6695 Medicines in Development Cancer 2012 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status ridaforolimus ARIAD Pharmaceuticals Cambridge, MA Merck Whitehouse Station, NJ metastatic breast cancer (see also kidney, lung, prostate, sarcoma, other) Phase II (800) 672-6372 rucaparib Clovis Oncology Boulder, CO (see also ovarian) Phase II (303) 625-5000 sagopilone Bayer HealthCare Pharmaceuticals Wayne, NJ (see also ovarian, prostate) Phase II completed (888) 842-2937 samarium SM-153 lexidronam injection EUSA Pharma Langhorne, PA (see also multiple myeloma, prostate, sarcoma, other) Phase II (800) 833-3533 SAR245408 (XL147) (oral PI3K inhibitor) Sanofi US Bridgewater, NJ Exelixis South San Francisco, CA (see also other) Phase II (800) 981-2491 (650) 837-7000 SAR245409 (XL765) (PI3K/mTOR inhibitor) Sanofi US Bridgewater, NJ Exelixis South San Francisco, CA (see also lymphoma) Phase II (800) 981-2491 (650) 837-7000 SAR256212 (MM-121) (anti-ErbB3 mAb) Merrimack Pharmaceuticals Cambridge, MA Sanofi US Bridgewater, NJ (see also lung, ovarian) Phase II (800) 981-2491 SF1 (sonodynamic therapy) SonneMed Boston, MA advanced breast cancer Phase I/II www.sonnemed.com SPRYCEL® dasatinib Bristol-Myers Squibb Princeton, NJ (see also brain, pancreatic, prostate, other) in clinical trials (800) 332-2056 SR 16234 SRI International Menlo Park, CA Tarceva® erlotinib Genentech South San Francisco, CA OSI Pharmaceuticals Farmingdale, NY (see also brain, head/neck, leukemia, liver, lung, other) Phase II (800) 626-3553 (631) 962-0600 tesetaxel Genta Berkeley Heights, NJ first-line breast cancer (see also bladder, prostate, skin, stomach) Phase II (908) 286-9800 Medicines in Development Cancer 2012 Phase II (650) 859-2000 15 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status ThermoDox® doxorubicin liposomal Celsion Lawrenceville, NJ recurrent breast cancer (see also colorectal, liver) Phase I/II (609) 896-9100 tigatuzumab (anti-DR5 antibody) Daiichi Sankyo Parsippany, NJ (see also colorectal, liver, lymphoma, ovarian, pancreatic) Phase II (973) 944-2600 tivozanib (ASP4130/AV-951) Astellas Pharma US Deerfield, IL AVEO Pharmaceuticals Cambridge, MA breast cancer (combination therapy) (see also colorectal, kidney) Phase I/II (800) 695-4321 (617) 299-5000 TKI258 (dovitinib) Novartis Pharmaceuticals East Hanover, NJ metastatic breast cancer (see also kidney, multiple myeloma, prostate, skin, other) Phase II (888) 669-6682 trabectedin Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ metastatic breast cancer (see also ovarian, prostate, sarcoma) Phase III (800) 817-5286 trastuzumab-DM1 (RG3502) Genentech South San Francisco, CA trastuzumab-DM1 companion diagnostic (HercepTest™) Dako Glostrup, Denmark Genentech South San Francisco, CA breast cancer (diagnosis) Phase III www.dako.com (800) 626-3553 trastuzumab-DM1 companion diagnostic (HER2 FISH pharmDx™) Dako Glostrup, Denmark Genentech South San Francisco, CA breast cancer (diagnosis) Phase III www.dako.com (800) 626-3553 TRC 105 (ENG protein inhibitor) TRACON Pharmaceuticals San Diego, CA (see also ovarian, prostate, other) Phase I/II (858) 550-0780 trebananib (AMG386) Amgen Thousand Oaks, CA (see also colorectal, kidney, liver, ovarian, stomach, other) Phase II (800) 772-6436 Tykerb® lapatinib GlaxoSmithKline Rsch. Triangle Park, NC inflammatory breast cancer (see also colorectal, head/neck, stomach) -------------------------------------------------adjuvant breast cancer, first-line metastatic breast cancer -------------------------------------------------neoadjuvant breast cancer application submitted (888) 825-5249 upamostat (WX-671) 16 Wilex Munich, Germany Phase III (800) 626-3553 ------------------------------------------Phase III (888) 825-5249 ------------------------------------------Phase II (888) 825-5249 Phase II www.wilex.de Medicines in Development Cancer 2012 Medicines in Development for Cancer Breast Cancer Product Name Sponsor Indication Development Status varlitinib ASLAN Pharmaceuticals Singapore VeriStrat® companion diagnostic test EGFR-TKI Biodesix Boulder, CO advanced breast cancer (diagnosis-outcome test in HER2-overexpressing tumors) Phase III (303) 417-0500 YM155 (sepantronium) Astellas Pharma US Deerfield, IL (see also lymphoma) Phase II (800) 695-4321 Zolinza® vorinostat Merck Whitehouse Station, NJ (see also leukemia, lung, lymphoma, multiple myeloma, other) Phase II (800) 672-6273 Zytiga® abiraterone Janssen Biotech Horsham, PA second-line metastatic breast cancer (see also prostate) Phase II (800) 526-7736 Product Name Sponsor Indication Development Status ADXS-HPV Advaxis Princeton, NJ cervical cancer, cervical intraepithelial neoplasia Phase II (609) 452-9813 PM-00104 PharmaMar Madrid, Spain (see also sarcoma, other) Phase II www.pharmamar.com PV701 (replication-competent oncolytic virus) Wellstat Biologics Gaithersburg, MD (see also colorectal) Phase II (240) 683-2500 terameprocol Erimos Pharmaceuticals Houston, TX cervical intraepithelial neoplasia (intravaginal) (see also brain, head/neck, solid tumors, other) Phase II (713) 541-2000 V503 (HPV virus-like particle (VLP) vaccine) Merck Whitehouse Station, NJ prevention of cervical cancer, prevention of vulvovaginal cancer Phase III (800) 672-6372 V505 (HPV vaccine) Merck Whitehouse Station, NJ prevention of cervical cancer Phase II completed (800) 672-6372 Phase II www.aslanpharma.com Cervical Cancer Medicines in Development Cancer 2012 17 Medicines in Development for Cancer Cervical Cancer Product Name Sponsor Indication Development Status verpasep caltespen (cancer vaccine) Akela Pharma Austin, TX cervical intraepithelial neoplasia Phase I completed (512) 834-0449 VGX-3100 (DNA cancer vaccine) Inovio Pharmaceuticals Blue Bell, PA cervical intraepithelial neoplasia Phase II (877) 446-6846 Colorectal Cancer Product Name Sponsor Indication Development Status ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL (see also brain, breast, lung, lymphoma, ovarian, prostate, skin, other) Phase II (847) 937-6100 Aptocine™ talaporfin Light Sciences Oncology Bellevue, WA metastatic colorectal cancer Phase III (425) 957-8900 AUY922 (Hsp90 inhibitor) Novartis Pharmaceuticals East Hanover, NJ second-line colorectal cancer (combination therapy) (see also breast, lung, multiple myeloma, stomach) Phase I (888) 669-6682 Avastin® bevacizumab Genentech South San Francisco, CA metastatic colorectal cancer (treatment beyond progression) (see also brain, breast, lung, ovarian, other) Phase III (800) 626-3553 AVX701 (CEA cancer immunotherapy) AlphaVax Rsch. Triangle Park, NC colorectal cancer prevention in patients with advanced or metastatic CEA-expressing malignancies Phase I/II (919) 595-0400 belinostat Spectrum Pharmaceuticals Henderson, NV colorectal cancer (combination therapy) (see also leukemia, liver, lung, lymphoma, ovarian, other) Phase I/II (702) 835-6300 brivanib (VEGFR/FGFR kinase inhibitor) Bristol-Myers Squibb Princeton, NJ metastatic colorectal cancer (see also liver, sarcoma) Phase II (800) 332-2056 CPX-1 (irinotecan/floxuridine) Celator Pharmaceuticals Princeton, NJ CT-011 CureTech Yavne, Israel E7820 Eisai Woodcliff Lake, NJ 18 Phase II completed (609) 243-0123 first-line metastatic colorectal cancer (combination therapy) (see also leukemia, lymphoma) Phase II www.curetechbio.com Phase II (888) 422-4743 Medicines in Development Cancer 2012 Medicines in Development for Cancer Colorectal Cancer Product Name Sponsor Indication Development Status efatutazone Daiichi Sankyo Parsippany, NJ metastatic colorectal cancer (see also lung, other) Phase II (973) 944-2600 EGEN-001 EGEN Huntsville, AL (see also ovarian, other) Phase I/II (256) 512-0077 EGFR antagonist companion diagnostic QIAGEN Valencia, CA colorectal cancer (diagnosis) application submitted www.qiagen.com encapsulated cell therapy (macrobeads) Rogosin Institute New York, NY refractory metastatic colorectal cancer (see also pancreatic, prostate) Phase II (212) 746-1566 entinostat Syndax Pharmaceuticals Waltham, MA metastatic colorectal cancer (combination therapy) (see also breast, kidney, leukemia, lung, lymphoma) Phase II (781) 419-1400 ERBITUX® cetuximab Bristol-Myers Squibb Princeton, NJ Eli Lilly Indianapolis, IN first-line colorectal cancer (see also stomach) in clinical trials (800) 332-2056 (800) 545-5979 etirinotecan pegol (NKTR-102) Nektar Therapeutics San Francisco, CA second-line colorectal cancer (see also breast, ovarian, solid tumors) Phase II/III (855) 482-6587 EZN-2208 (PEG-SN38, firtecan pegol) Enzon Pharmaceuticals Piscataway, NJ metastatic colorectal cancer (see also breast, solid tumors) Phase II (973) 980-4500 FANG™ Vaccine autologous tumor cell vaccine Gradalis Carrollton, TX (see also ovarian, skin) Phase II (214) 442-8100 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA refractory, metastatic colorectal cancer (see also breast, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach) Phase II (781) 274-8200 ganitumab (AMG 479) Amgen Thousand Oaks, CA second-line metastatic colorectal cancer (combination therapy) (see also breast, lung, pancreatic, sarcoma) Phase II (800) 772-6436 GI-4000 (cancer vaccine) GlobeImmune Louisville, CO (see also lung, pancreatic) Phase II (303) 625-2700 Medicines in Development Cancer 2012 19 Medicines in Development for Cancer Colorectal Cancer Product Name Sponsor Indication Development Status GM-CT-01 Galectin Therapeutics Newton, MA colorectal cancer (combination therapy) Phase II (617) 559-0033 GS-6624 (monoclonal antibody) Gilead Sciences Foster City, CA (see also pancreatic) Phase II (800) 445-3235 GVAX® Colorectal cancer vaccine BioSante Pharmaceuticals Lincolnshire, IL icrucumab (LY3012212/IMC-18F1) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ (see also bladder, breast) Phase II (800) 545-5979 IMO-2055 (TLR9 agonist) Idera Pharmaceuticals Cambridge, MA (see also head/neck, lung) Phase I (617) 679-5000 Imprime PGG® Biothera Eagan, MN (see also leukemia, lung, skin) Phase III (651) 675-0300 JX-594 (pexastimogene devacirepvec) Jennerex Biotherapeutics San Francisco, CA (see also liver) Phase I/II (415) 281-8886 KRN-330 Kyowa Hakko Kirin Pharma Princeton, NJ colorectal cancer (combination therapy) -------------------------------------------------colorectal cancer (monotherapy) Phase I/II (609) 919-1100 ------------------------------------------Phase I (609) 919-1100 labetuzumab I-131 (IMMU-111) Immunomedics Morris Plains, NJ Phase II (973) 605-8200 labetuzumab-SN-38 (IMMU-130) Immunomedics Morris Plains, NJ Phase I (973) 605-8200 LGX818 (RAF inhibitor) Novartis Pharmaceuticals East Hanover, NJ metastatic colorectal cancer (see also skin) Phase I (888) 669-6682 linifanib Abbott Laboratories Abbott Park, IL second-line colorectal cancer (see also breast, kidney, liver, lung) Phase II (847) 937-6100 LOR-2040 Lorus Therapeutics Toronto, Canada metastatic colorectal cancer (see also breast, kidney, leukemia, prostate) Phase II (416) 798-1200 motesanib Amgen Thousand Oaks, CA (see also breast, lung, other) Phase I (800) 772-6436 20 Phase I (847) 478-0500 Medicines in Development Cancer 2012 Medicines in Development for Cancer Colorectal Cancer Product Name Sponsor Indication Development Status Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ metastatic colorectal cancer (see also breast, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other) Phase II (888) 842-2937 NPC-1C (ensituximab) Neogenix Oncology Rockville, MD metastatic colorectal cancer (see also pancreatic) Phase I (301) 917-6893 onartuzumab Genentech South San Francisco, CA (see also breast, lung) Phase II (800) 626-3553 OncoVAX® active specific immunotherapy Vaccinogen Frederick, MD (Fast Track) Phase I/II (301) 668-8400 perifosine AEterna Zentaris Basking Ridge, NJ refractory metastatic colorectal cancer (combination therapy) (Fast Track) (see also brain, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach) Phase III (908) 626-5428 PHY906 PhytoCeutica New Haven, CT (see also liver, pancreatic, cancer-related) Phase I/II (203) 777-3462 picoplatin Ponaird Pharmaceuticals Seattle, WA (see also lung, ovarian, prostate) Phase II (206) 281-7001 polyclonal antibody stimulator Cancer Advances Durham, NC (see also pancreatic, stomach) Phase II (919) 361-2162 PV701 (replication-competent oncolytic virus) Wellstat Biologics Gaithersburg, MD (see also cervical) Phase II (240) 683-2500 ramucirumab (IMC-1121B) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ (see also breast, stomach) Phase III (800) 545-5979 regorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ metastatic colorectal cancer (Fast Track) (see also kidney, lung, solid tumors, stomach) Phase III (888) 842-2837 Reolysin® reovirus Oncolytics Biotech Calgary, Canada (see also brain, head/neck, lung, ovarian, pancreatic, sarcoma, skin, solid tumors) Phase I (403) 670-7377 Medicines in Development Cancer 2012 21 Medicines in Development for Cancer Colorectal Cancer Product Name Sponsor Indication Development Status RG7160 (EGFR inhibitor) Roche Nutley, NJ second-line metastatic colorectal cancer (combination therapy) Phase II (973) 235-5000 RG7414 (EGFL7 inhibitor) Genentech South San Francisco, CA (see also lung) Phase II (800) 626-3553 RIGScan™ tumor-specific, radio-labeled monoclonal antibody targeting agent Navidea Biopharmaceuticals Dublin, OH metastatic colorectal cancer (diagnosis) application submitted (800) 793-0079 robatumumab Merck Whitehouse Station, NJ (see also sarcoma, solid tumors) Phase II completed (800) 672-6372 Sym004 Symphogen Lyngby, Denmark metastatic colorectal cancer Phase II www.symphogen.com TAS-102 Taiho Pharma U.S.A. Princeton, NJ telatinib ACT Biotech San Francisco, CA (see also stomach) Phase I (415) 230-3900 TF2 (pretargeted radioimmunotherapy) Immunomedics Morris Plains, NJ colorectal cancer Phase I (973) 605-8200 ThermoDox® doxorubicin liposomal Celsion Lawrenceville, NJ adjuvant inoperable/unresectable, metastatic colorectal cancer (see also breast, liver) Phase II (609) 896-9100 tigatuzumab (anti-DR5 antibody) Daiichi Sankyo Parsippany, NJ (see also breast, liver, lymphoma, ovarian, pancreatic) Phase I (973) 944-2600 tivantinib (ARQ 197) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ (see also kidney, liver, lung, pancreatic, sarcoma, other) Phase I/II (781) 994-0300 (973) 944-2600 tivozanib (ASP4130/AV-951) Astellas Pharma US Deerfield, IL AVEO Pharmaceuticals Cambridge, MA colorectal cancer (combination therapy) (see also breast, kidney) Phase II (800) 695-4321 (617) 299-5000 trebananib (AMG386) Amgen Thousand Oaks, CA (see also breast, kidney, liver, ovarian, stomach, other) Phase II (800) 772-6436 Tykerb® lapatinib GlaxoSmithKline Rsch. Triangle Park, NC metastatic colorectal cancer (see also breast, head/neck, stomach) Phase II (888) 825-5249 22 Phase I (609) 750-5300 Medicines in Development Cancer 2012 Medicines in Development for Cancer Colorectal Cancer Product Name Sponsor Indication Development Status Vectibix® panitumumab Amgen Thousand Oaks, CA first-line and second-line colorectal cancer (see also head/neck) application submitted (800) 772-6436 Xeloda® capecitabine Genentech South San Francisco, CA first-line and second-line metastatic colorectal cancer (combination therapy) (see also brain, liver, stomach) application submitted (800) 626-3553 Zaltrap™ aflibercept Regeneron Pharmaceuticals Tarrytown, NY Sanofi US Bridgewater, NJ second-line metastatic colorectal cancer (see also prostate) application submitted (914) 345-7400 (800) 981-2491 Zelboraf® vemurafenib Genentech South San Francisco, CA Plexxikon Berkeley, CA (see also brain, other) Phase I (800) 626-3553 Head/Neck Cancer Product Name Sponsor Indication Development Status ACE-041 (dalantercept) Acceleron Pharma Cambridge, MA (see also multiple myeloma) Phase II (617) 649-9200 afatinib (BIBW2992) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT second-line head/neck cancer (see also breast, brain, lung) Phase II (800) 243-0127 AP5346 Access Pharmaceuticals Dallas, TX E7050 Eisai Woodcliff Lake, NJ (see also brain, liver, skin, solid tumors, stomach) Phase I/II (888) 422-4743 foretinib (GSK1363089) GlaxoSmithKline Rsch. Triangle Park, NC (see also kidney, liver, lung) Phase II completed (888) 825-5249 GL-0810 (Orphan Drug) Gliknik Baltimore, MD GL-0817 (Orphan Drug) Gliknik Baltimore, MD HF-10 Takara Bio Shiga, Japan Medicines in Development Cancer 2012 Phase II (214) 905-5100 Phase I www.gliknik.com (see also multiple myeloma) Phase I www.gliknik.com Phase I www.takara-bio.com 23 Medicines in Development for Cancer Head/Neck Cancer Product Name Sponsor Indication Development Status IMO-2055 (TLR9 agonist) Idera Pharmaceuticals Cambridge, MA second-line head and neck cancer (combination therapy) (see also colorectal, lung) Phase II (617) 679-5000 IRX-2 IRX Therapeutics New York, NY (Fast Track) Phase II (212) 582-1199 Lymphoseek® Tc-99m tilmanocept Navidea Pharmaceuticals Dublin, OH head and neck cancer (diagnosis) (see also breast, skin) Phase III (614) 793-7500 Multikine® leukocyte interleukin (Orphan Drug) CEL-SCI Vienna, VA first-line head and neck cancer Phase III (703) 506-9460 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ (see also breast, colorectal, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other) Phase II (888) 842-2937 OBP-301 Oncolys Biopharma Tokyo, Japan (see also breast, liver, lung) Phase I www.oncolys.com PX-866 Oncothyreon Seattle, WA head and neck cancer (combination therapy) (see also brain, lung, prostate) Phase II (206) 801-2100 Reolysin® reovirus Oncolytics Biotech Calgary, Canada metastatic head and neck cancer (combination therapy) (see also brain, colorectal, lung, ovarian, pancreatic, sarcoma, skin, solid tumors) Phase III (403) 670-7377 RG7597 (EGFR antagonist) Genentech South San Francisco, CA seliciclib (CYC202) Cyclacel Pharmaceuticals Berkeley Heights, NJ nasopharyngeal cancer (see also solid tumors) Phase II (908) 517-7330 Tarceva® erlotinib Genentech South San Francisco, CA OSI Pharmaceuticals Farmingdale, NY first-line head/neck cancer (combination therapy) (see also brain, breast, leukemia, liver, lung, other) Phase II (800) 626-3553 (631) 962-0600 TAS-106 Taiho Pharma U.S.A. Princeton, NJ 24 Phase II (800) 626-3553 Phase II (609) 750-5300 Medicines in Development Cancer 2012 Medicines in Development for Cancer Head/Neck Cancer Product Name Sponsor Indication Development Status terameprocol Erimos Pharmaceuticals Houston, TX head and neck cancer (intratumoral) (see also brain, cervical, solid tumors, other) Phase I (713) 541-2000 TNFerade™ golnerminogene pradenovec GenVec Gaithersburg, MD (see also prostate, skin, stomach) Phase I/II completed (877) 943-6832 Tykerb® lapatinib GlaxoSmithKline Rsch. Triangle Park, NC head and neck squamous cell carcinoma (resectable disease) (see also breast, colorectal, stomach) Phase III (888) 825-5249 VB4-845 (Orphan Drug) Viventia Biotechnologies Mississauga, Canada (Fast Track) (see also bladder) Phase II (905) 362-2973 Vectibix® panitumumab Amgen Thousand Oaks, CA first-line head and neck cancer (see also colorectal) -------------------------------------------------second-line head and neck cancer Phase III (800) 772-6436 ------------------------------------------Phase II (800) 772-6436 Product Name Sponsor Indication Development Status Afinitor® everolimus Novartis Pharmaceuticals East Hanover, NJ hepatocellular carcinoma (see also breast, lymphoma) Phase II (888) 669-6682 AGS-003 (personalized dendritic cell vaccine) Argos Therapeutics Durham, NC renal cancer (combination therapy) (Fast Track) -------------------------------------------------metastatic renal cancer (monotherapy) Phase II (919) 287-6300 ------------------------------------------Phase II (919) 287-6300 AMG 172 Amgen Thousand Oaks, CA anti-PD1 (BMS-936558) Bristol-Myers Squibb Princeton, NJ BNC105 Bionomics Thebarton, Australia cabozantinib (XL184) Exelixis South San Francisco, CA Kidney Cancer Medicines in Development Cancer 2012 Phase I (800) 772-6436 renal cell carcinoma (see also lung, skin) Phase II (800) 332-2056 Phase II www.bionomics.com.au renal cell carcinoma (see also breast, lung, ovarian, prostate, other) Phase I (650) 837-7000 25 Medicines in Development for Cancer Kidney Cancer Product Name Sponsor Indication Development Status CVX 060 (PF-04856884) (Ang2 antagonist) Pfizer New York, NY renal cell carcinoma (see also solid tumors) Phase II (860) 732-5156 CYT107 (interleukin-7) Cytheris Rockville, MD (see also skin) Phase I (301) 231-0451 entinostat Syndax Pharmaceuticals Waltham, MA (see also breast, colorectal, leukemia, lung, lymphoma) Phase I/II (781) 419-1400 foretinib (GSK1363089) GlaxoSmithKline Rsch. Triangle Park, NC (see also head/neck, liver, lung) Phase II (888) 825-5249 IMA901 (cancer vaccine) immatics biotechnologies Tüebingen, Germany renal cancer Phase III www.immatics.com Inlyta® axitinib (Orphan Drug) Pfizer New York, NY advanced renal cell carcinoma in treatment-naive patients (see also liver, other) Phase III (860) 732-5156 Istodax® romidepsin Celgene Summit, NJ renal cancer (see also pancreatic, prostate, other) Phase II (908) 673-9000 LBH589 (panobinostat) Novartis Pharmaceuticals East Hanover, NJ renal cancer (see also leukemia, multiple myeloma, prostate, solid tumors) Phase II (888) 669-6682 linifanib Abbott Laboratories Abbott Park, IL renal cancer (see also breast, colorectal, liver, lung) Phase II (847) 937-6100 LOR-2040 (Orphan Drug) Lorus Therapeutics Toronto, Canada metastatic renal cancer (see also breast, colorectal, leukemia, prostate) Phase II (416) 798-1200 naptumomab estafenatox Active Biotech Lund, Sweden (see also lung, pancreatic) Phase I completed www.activebiotech.com Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ renal cell carcinoma (adjuvant therapy) (see also breast, colorectal, head/neck, leukemia, liver, lung, multiple myeloma, ovarian, other) Phase III (888) 842-2937 Oncophage® vitespen (Orphan Drug) Agenus Lexington, MA renal cell carcinoma (Fast Track) Phase II (781) 674-4400 OSI-027 (TORC1/TORC2 inhibitor) OSI Pharmaceuticals Farmingdale, NY renal cancer (see also lymphoma) Phase II (631) 962-0600 26 Medicines in Development Cancer 2012 Medicines in Development for Cancer Kidney Cancer Product Name Sponsor Indication Development Status perifosine AEterna Zentaris Basking Ridge, NJ metastatic renal cancer (see also brain, colorectal, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach) Phase II (908) 626-5428 Redectane® girentuximab I-124 companion diagnostic Wilex Munich, Germany renal cancer (diagnosis) Phase III completed www.wilex.de regorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ renal cancer (see also colorectal, lung, solid tumors, stomach) Phase II (888) 842-2837 Rencarex® girentuximab (Orphan Drug) Wilex Munich, Germany clear cell renal cell carcinoma (Fast Track) Phase III www.wilex.de ridaforolimus ARIAD Pharmaceuticals Cambridge, MA Merck Whitehouse Station, NJ (see also breast, lung, prostate, sarcoma, other) Phase I (800) 672-6372 SGN-75 (vorsetuzumab mafodotin) Seattle Genetics Bothell, WA renal cancer (see also lymphoma) Phase I (425) 527-4000 Sutent® sunitinib (Orphan Drug) Pfizer New York, NY renal cell carcinoma (adjuvant therapy) Phase III (860) 732-5156 tivantinib (ARQ 197) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ (see also colorectal, liver, lung, pancreatic, sarcoma, other) Phase II (781) 994-0300 (973) 944-2600 tivozanib (ASP4130/AV-951) Astellas Pharma US Deerfield, IL AVEO Pharmaceuticals Cambridge, MA first-line renal cancer (see also breast, colorectal) Phase III (800) 695-4321 (617) 299-5000 ------------------------------------------Phase I (800) 695-4321 (617) 299-5000 TKI258 (dovitinib) Novartis Pharmaceuticals East Hanover, NJ (see also breast, multiple myeloma, prostate, skin, other) Phase III (888) 669-6682 Torisel® temsirolimus (Orphan Drug) Pfizer New York, NY renal cell carcinoma Phase III (860) 732-5156 trebananib (AMG386) Amgen Thousand Oaks, CA renal cancer (see also breast, colorectal, liver, ovarian, stomach, other) Phase II (800) 772-6436 Medicines in Development Cancer 2012 -------------------------------------------------renal cancer (combination therapy) 27 Medicines in Development for Cancer Kidney Cancer Product Name Sponsor Indication Development Status TVI-Kidney-1 (cellular immunotherapy vaccine) TVAX Biomedical Lenexa, KS renal cell carcinoma Phase II completed (913) 492-2221 veglin (VEGF antisense) VasGene Therapeutics Los Angeles, CA (see also lung, skin) Phase I (323) 221-7818 Votrient™ pazopanib GlaxoSmithKline Rsch. Triangle Park, NC (see also ovarian, other) Phase III (888) 825-5249 Product Name Sponsor Indication Development Status ABIO-0501 (TALL104) Abiogen Pharma Pisa, Italy chronic myeloid leukemia (CML) Phase II www.abiogen.it AC220 (quizartinib) Ambit Biosciences San Diego, CA Astellas Pharma US Deerfield, IL second-line and third-line acute myeloid leukemia (AML) (monotherapy) (see also solid tumors) -------------------------------------------------acute lymphocytic leukemia (ALL) (combination therapy), first-line AML Phase II (858) 334-2100 (800) 695-4321 Leukemia ------------------------------------------Phase I (858) 334-2100 (800) 695-4321 AC430 (JAK2 inhibitor) Ambit Biosciences San Diego, CA Adcetris™ brentuximab vedotin Millennium Pharmaceuticals Cambridge, MA Seattle Genetics Bothell, WA (see also lymphoma) Phase II (800) 390-5663 (425) 527-4000 AEG35156 (XIAP inhibitor) Aegera Therapeutics Montreal, Canada AML (see also lymphoma) -------------------------------------------------chronic lymphocytic leukemia (CLL) Phase II (514) 288-5532 ------------------------------------------Phase I/II (514) 288-5532 AFX-9154 Afecta Pharmaceuticals Irvine, CA 28 Phase I (858) 334-2100 in clinical trials (949) 253-4688 Medicines in Development Cancer 2012 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status AGS-005 Argos Therapeutics Durham, NC CLL Phase I/II (919) 287-6300 ALD-151 Aldagen Durham, NC ALXN6000 (samalizumab) Alexion Pharmaceuticals Cheshire, CT CLL (see also multiple myeloma) Phase I/II completed (203) 272-2596 aminopterin Syntrix Biosystems Auburn, WA ALL Phase II completed (253) 833-8009 anti-CD22/CD19 mAb-toxin conjugate Abiogen Pharma Pisa, Italy ALL Phase I www.abiogen.com AR-42 Arno Therapeutics Flemington, NJ CLL (see also lymphoma, multiple myeloma) Phase I/II (862) 703-7170 AR-67 Arno Therapeutics Flemington, NJ myelodysplastic syndromes (see also brain, solid tumors) Phase II (862) 703-7170 Arranon® nelarabine (Orphan Drug) GlaxoSmithKline Rsch. Triangle Park, NC first-line ALL (see also lymphoma) -------------------------------------------------second-line ALL Phase III (888) 669-6682 ------------------------------------------Phase I/II (888) 669-6682 ARRY-520 (KSP inhibitor) Array BioPharma Boulder, CO AML (see also multiple myeloma, solid tumors) Phase II (877) 633-2436 Arzerra® ofatumumab (Orphan Drug) GlaxoSmithKline Rsch. Triangle Park, NC first-line CLL (combination therapy) (see also lymphoma) Phase III (888) 825-5249 AT-101 (oral pan Bcl-2 inhibitor) Ascenta Therapeutics Malvern, PA CLL (see also brain, lung, lymphoma, prostate, stomach) Phase II (610) 408-0301 AT-406/Debio-1143 Ascenta Therapeutics Malvern, PA Debiopharm Lausanne, Switzerland AML (see also lymphoma) Phase I (610) 408-0301 www.debiopharm.com Medicines in Development Cancer 2012 Phase I (919) 484-2571 29 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status AT7519 (CDK inhibitor) Astex Pharmaceuticals Dublin, CA CLL (see also lymphoma, multiple myeloma, solid tumors) Phase II (925) 560-0100 AT9283 (aurora/Jak2 inhibitor) (Orphan Drug) Astex Pharmaceuticals Dublin, CA AML (see also lymphoma, multiple myeloma, solid tumors) Phase I/II (925) 560-0100 AVL-292 (Btk inhibitor) Celgene Summit, NJ second-line CLL (combination therapy) (see also lymphoma, unspecified) Phase I (908) 673-9000 AZD1208 (Pim kinase inhibitor) AstraZeneca Wilmington, DE AML Phase I (800) 236-9933 bafetinib (Orphan Drug) CytRx Los Angeles, CA second-line CLL (see also brain, prostate) -------------------------------------------------ALL, CML Phase II (310) 826-5648 ------------------------------------------Phase I (310) 826-5648 Bcl-2 inhibitor (ABT-199/GDC-0199) Abbott Laboratories Abbott Park, IL Genentech South San Francisco, CA CLL (see also lymphoma) Phase I (847) 937-6100 (800) 626-3553 belinostat Spectrum Pharmaceuticals Henderson, NV AML (see also colorectal, liver, lung, lymphoma, ovarian, other) Phase I/II (702) 835-6300 BI-811283 (aurora kinase B inhibitor) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT AML (see also solid tumors) Phase I/II (800) 243-0127 BI-836826 Boehringer Ingelheim Pharmaceuticals Ridgefield, CT CLL Phase I (800) 243-0127 bosutinib Pfizer New York, NY previously treated CML application submitted (860) 732-5156 cenersen (Orphan Drug) Eleos Omaha, NE AML Phase II completed (402) 393-3034 Ceplene® histamine dihydrochloride injection (Orphan Drug) EpiCept Tarrytown, NY AML application submitted (914) 606-3500 30 Medicines in Development Cancer 2012 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status CLL immunotherapeutic vaccine MaxCyte Gaithersburg, MD CLL Phase I/II (301) 944-1700 Clolar® clofarabine injection (Orphan Drug) Genzyme Cambridge, MA AML (adults) Phase III (617) 252-7500 CNDO-109 (tumor activated NK cells) Coronado Biosciences Burlington, MA AML Phase I (781) 238-6621 CPX-351 (cytarabine/daunorubicin) (Orphan Drug) Celator Pharmaceuticals Princeton, NJ AML Phase II (609) 243-0123 CT-011 CureTech Yavne, Israel second-line AML (combination therapy) (see also colorectal, lymphoma) Phase II www.curetechbio.com CWP232291 JW Pharmaceutical Seoul, South Korea AML Phase I Dacogen® decitabine Eisai Woodcliff Lake, NJ AML application submitted (888) 422-4743 ------------------------------------------Phase II (888) 422-4743 danusertib Nerviano Medical Sciences Nerviano, Italy CML Phase II www.nervianoms.com DCC-2036 Deciphera Pharmaceuticals Lawrence, KS ALL, CML Phase I/II (785) 830-2100 ------------------------------------------Phase I (785) 830-2100 DCDS-4501A Genentech South San Francisco, CA CLL (see also lymphoma) Phase I (800) 626-3553 DCDT-2980S Genentech South San Francisco, CA recurrent CLL (see also lymphoma) Phase I (800) 626-3553 Elacyt™ elacytarabine (Orphan Drug) Clavis Pharma Oslo, Norway late-stage AML (Fast Track) -------------------------------------------------early-stage AML Phase III www.clavispharma.com ------------------------------------------Phase II www.clavispharma.com Medicines in Development Cancer 2012 -------------------------------------------------pediatric AML -------------------------------------------------AML 31 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status elesclomol Synta Pharmaceuticals Lexington, MA AML (see also lung, ovarian) Phase I (781) 274-8200 entinostat Syndax Pharmaceuticals Waltham, MA (see also breast, colorectal, kidney, lung, lymphoma) Phase II (781) 419-1400 epratuzumab (Orphan Drug) Immunomedics Morris Plains, NJ UCB Atlanta, GA ALL in children (combination therapy) (see also lymphoma) Phase II (973) 605-8200 forodesine (Orphan Drug) BioCryst Pharmaceuticals Durham, NC CLL (see also lymphoma) Phase II (919) 859-1302 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA ALL, AML, CML (see also breast, colorectal, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach) -------------------------------------------------myelodysplastic syndromes Phase I/II (781) 274-8200 ------------------------------------------Phase I (781) 274-8200 GNKG-168 SBI Biotech Tokyo, Japan CLL Phase I www.sbibiotech.jp GRNVAC1 (dendritic cell vaccine) Argos Therapeutics Durham, NC Geron Menlo Park, CA AML (see also prostate) Phase II (650) 473-7700 GS-1101 (PI3K delta inhibitor) Gilead Sciences Foster City, CA second-line CLL (see also lymphoma) Phase III (800) 445-3235 GSK2110183 (protein kinase B inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also multiple myeloma) Phase II (888) 825-5249 GSK2130579A (WT1 antigen-specific cancer immunotherapeutic) GlaxoSmithKline Rsch. Triangle Park, NC AML Phase II (888) 825-5249 GVAX® Leukemia cancer vaccine (Orphan Drug) BioSante Pharmaceuticals Lincolnshire, IL AML, CML Phase II (847) 478-0500 HuM195-Ac-225 (lintuzumab Ac-225) Actinium Pharmaceuticals Newark, NJ AML Phase I (973) 344-6500 32 Medicines in Development Cancer 2012 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status HuM195-Bi-213 (lintuzumab Bi-213) Actinium Pharmaceuticals Newark, NJ AML Phase I/II (973) 344-6500 HuM195/rGel (lintuzumab-gelonin conjugate) Targa Therapeutics San Diego, CA AML, CML, myelodysplastic syndromes Phase I (858) 483-6600 ibrutinib (PCI-32765) Janssen Biotech Horsham, PA Pharmacyclics Sunnyvale, CA CLL (see also lymphoma, multiple myeloma) Phase I/II (800) 526-7736 (408) 774-0330 imatinib sublingual Kedem Pharmaceuticals Mesa, AZ CML in clinical trials (604) 324-4244 imetelstat Geron Menlo Park, CA CLL (see also breast, lung, multiple myeloma) Phase I/II (650) 473-7700 Imprime PGG® Biothera Eagan, MN CLL (see also colorectal, lung, skin) Phase I/II (651) 675-0300 INNO-305 (WT-1 vaccine) CytRx Los Angeles, CA AML, myelodysplastic syndromes (see also solid tumors) Phase I (310) 826-5648 inotuzumab ozogamicin Pfizer New York, NY ALL (see also lymphoma) Phase I (860) 732-5156 ISF35 (recombinant immunotherapeutic vaccine) Memgen San Diego, CA CLL (monotherapy) (see also lymphoma) -------------------------------------------------refractory metastatic CLL (combination therapy) Phase II (858) 524-5400 ------------------------------------------Phase I (858) 524-5400 JNJ-26481585 (quisinostat) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ myelodysplastic syndromes, metastatic leukemia (see also lymphoma) Phase I (800) 817-5286 JVRS-100 (lipid-DNA complex vaccine) Colby Pharmaceutical San Jose, CA KX2-391 Kinex Pharmaceuticals Buffalo, NY Medicines in Development Cancer 2012 Phase I (650) 333-3152 AML in the elderly (see also prostate) Phase I (716) 898-8626 33 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status LBH589 (panobinostat) Novartis Pharmaceuticals East Hanover, NJ ALL, AML, myelodysplastic syndromes (see also kidney, multiple myeloma, prostate, solid tumors) Phase II (888) 669-6682 LDE225 (erismodegib) Novartis Pharmaceuticals East Hanover, NJ CML (combination therapy) (see also pancreatic, solid tumors, skin) Phase I (888) 669-6682 lestaurtinib (Orphan Drug) Cephalon Frazer, PA AML Phase II (610) 344-0200 leukemia DNA vaccine Inovio Pharmaceuticals Blue Bell, PA University of Southampton Southampton, United Kingdom AML, CML Phase II (877) 446-6846 LG740 (activated T-cells) Lentigen Gaithersburg, MD University of Pennsylvania Philadelphia, PA ALL, B-cell prolymphocytic leukemia, CLL (see also lymphoma) Phase I (301) 527-4200 LOR-2040 (Orphan Drug) Lorus Therapeutics Toronto, Canada AML (combination therapy) (see also breast, colorectal, kidney, prostate) -------------------------------------------------CML, myelodysplastic syndromes Phase II (416) 798-1200 ------------------------------------------Phase I (416) 798-1701 lurbinectedin PharmaMar Madrid, Spain (see also solid tumors) Phase I www.pharmamar.com Marqibo® vincristine liposomal (Orphan Drug) Talon Therapeutics San Mateo, CA relapsed or refractory Philadelphia chromosome-negative ALL (Fast Track) (see also lymphoma, skin, other) -------------------------------------------------ALL in the elderly (Fast Track) application submitted (650) 588-6404 ------------------------------------------Phase III (650) 588-6404 milatuzumab Immunomedics Morris Plains, NJ CLL (monotherapy) (see also lymphoma, multiple myeloma) Phase I/II (973) 605-8200 MK-7956 (dinaciclib) (Orphan Drug) Merck Whitehouse Station, NJ CLL (see also lymphoma) Phase II (800) 672-6372 34 Medicines in Development Cancer 2012 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status MK-8242 Merck Whitehouse Station, NJ AML (see also solid tumors) Phase I (800) 672-6372 mocetinostat (MGCD0103, HDAC inhibitor) MethylGene Montreal, Canada CLL (see also lymphoma, solid tumors) Phase II completed (514) 337-3333 Mozobil® plerixafor Genzyme Cambridge, MA AML Phase I (617) 252-7500 navitoclax (ABT-263) Abbott Laboratories Abbott Park, IL first-line CLL (combination therapy) (see also lung, lymphoma) -------------------------------------------------CLL, lymphoid leukemia Phase II (847) 937-6100 ------------------------------------------Phase I (847) 937-6100 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ AML, myelodysplastic syndromes (see also breast, colorectal, head/neck, kidney, liver, lung, multiple myeloma, ovarian, other) Phase I/II (888) 842-2937 obatoclax (Orphan Drug) Cephalon Frazer, PA CLL (see also lung, lymphoma, multiple myeloma) Phase I/II completed (610) 344-0200 obinutuzumab (GA101/RG7159) Biogen Idec Weston, MA Genentech South San Francisco, CA first-line CLL (combination therapy) (see also lymphoma) Phase III (781) 464-2000 (800) 626-3553 Omapro™ omacetaxine (Orphan Drug) Cephalon Frazer, PA second-line CML (see also solid tumors) -------------------------------------------------AML, myelodysplastic syndromes application submitted (610) 344-0200 ------------------------------------------Phase II (610) 344-0200 ON 013105 Onconova Therapeutics Newtown, PA ALL (see also lymphoma) Phase I (267) 759-3680 oral azacitidine (Orphan Drug) Celgene Summit, NJ myelodysplastic syndromes (Fast Track) (see also lung, lymphoma, solid tumors) -------------------------------------------------AML, CML Phase II (908) 673-9000 Medicines in Development Cancer 2012 ------------------------------------------Phase I (908) 673-9000 35 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status oral clofaribine Genzyme Cambridge, MA myelodysplastic syndromes Phase I (617) 252-7500 OVI-123 (Orphan Drug) OncoVista Innovative Therapies San Antonio, TX TdT-positive leukemia Phase I (210) 677-6000 OXi4503 OXiGENE South San Francisco, CA AML, myelodysplastic syndromes Phase I (650) 635-7000 perifosine AEterna Zentaris Basking Ridge, NJ refractory metastatic CLL (see also brain, colorectal, kidney, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach) Phase II (908) 626-5428 PKC412 (midostaurin) Novartis Pharmaceuticals East Hanover, NJ AML Phase III (888) 669-6682 PLX3397 (CSF-1R kinase inhibitor) Plexxikon Berkeley, CA recurrent or refractory AML (see also brain, lymphoma, solid tumors) Phase I/II (510) 647-4000 ponatinib (Orphan Drug) ARIAD Pharmaceuticals Cambridge, MA Philadelphia-positive ALL, CML Phase II (617) 494-0400 ------------------------------------------Phase I (617) 494-0400 PR104 Proacta La Jolla, CA AML Phase I/II (858) 642-0386 Revlimid® lenalidomide (Orphan Drug) Celgene Summit, NJ CLL, myelodysplastic syndromes (see also lymphoma) Phase III (908) 673-9000 rigosertib (Orphan Drug) Onconova Therapeutics Newtown, PA myelodysplastic syndromes (intravenous) (see also lymphoma, ovarian, pancreatic) -------------------------------------------------CLL Phase III (267) 759-3680 -------------------------------------------------AML -------------------------------------------------AML -------------------------------------------------myelodysplastic syndromes (oral) 36 ------------------------------------------Phase II (267) 759-3680 ------------------------------------------Phase I/II (267) 759-3680 ------------------------------------------Phase I (267) 759-3680 Medicines in Development Cancer 2012 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status sapacitabine (CYC682) (Orphan Drug) Cyclacel Pharmaceuticals Berkeley Heights, NJ first-line AML (see also lung, solid tumors) -------------------------------------------------CLL (combination therapy), myelodysplastic syndromes Phase III (908) 517-7330 ------------------------------------------Phase II (908) 517-7330 SB989 (pracinostat) S*BIO Oakland, CA myelodysplastic syndromes (see also solid tumors, other) Phase I (650) 730-2860 SB1518 (pacritinib) S*BIO Oakland, CA myelodysplastic syndromes Phase II (650) 730-2860 ------------------------------------------Phase I/II (650) 730-2860 SF1126 (Orphan Drug) Semafore Pharmaceuticals Indianapolis, IN CLL (see also multiple myeloma, solid tumors) Phase I (317) 876-3075 SGI110 (DNMT inhibitor) Astex Pharmaceuticals Dublin, CA AML, myelodysplastic syndromes Phase I/II (925) 560-0100 SL-401 (recombinant fusion protein) (Orphan Drug) Stemline Therapeutics New York, NY AML, myelodysplastic syndromes Phase I/II (646) 502-2310 tamibarotene (Orphan Drug) CytRx Los Angeles, CA acute promyelocytic leukemia (APL) (Fast Track) (see also lung) -------------------------------------------------APL (combination therapy) Phase II (310) 826-5648 -------------------------------------------------myeloid leukemia ------------------------------------------Phase I (310) 826-5648 Tarceva® erlotinib Genentech South San Francisco, CA OSI Oncology Farmingdale, NY myelodysplastic syndromes (see also brain, breast, head/neck, liver, lung, other) Phase II (800) 626-3553 (631) 962-0600 Tasigna® nilotinib (Orphan Drug) Novartis Pharmaceuticals East Hanover, NJ CML (adolescents and children), ALL (adolescents and children) (see also skin, stomach) Phase II (888) 669-6682 Temodar® temozolomide Merck Whitehouse Station, NJ AML (see also lung) Phase II (800) 672-6372 TH-302 Threshold Pharmaceuticals South San Francisco, CA (see also brain, multiple myeloma, pancreatic, sarcoma) Phase I (650) 474-8200 thiarabine Access Pharmaceuticals Dallas, TX (see also lymphoma) Phase I/II (215) 904-5100 Medicines in Development Cancer 2012 37 Medicines in Development for Cancer Leukemia Product Name Sponsor Indication Development Status TL-32711 (birinapant) TetraLogic Pharmaceuticals Malvern, PA AML (see also solid tumors) Phase I/II (610) 889-9900 tosedostat (Orphan Drug) Chroma Therapeutics Oxon, United Kingdom AML Phase II www.chromatherapeutics.com trametinib GlaxoSmithKline Rsch. Triangle Park, NC relapsed or refractory leukemia (see also brain, lung, lymphoma, multiple myeloma, pancreatic, skin) Phase III (888) 825-5249 Treanda® bendamustine Cephalon Frazer, PA ALL in children, AML in children (see also lymphoma, multiple myeloma) Phase I/II (610) 344-0200 treosulfan Medac Wedel, Germany ALL, AML, myelodysplastic syndromes Phase II www.medac.de TRU-016 (humanized anti-CD37 therapeutic) Emergent BioSolutions Rockville, MD CLL (see also lymphoma) Phase II (301) 795-1800 Velcade® bortezomib Millennium Pharmaceuticals Cambridge, MA second-line T-cell prolymphocytic leukemia (see also lymphoma, other, cancer-related) Phase II (800) 390-5663 veltuzumab (Orphan Drug) Immunomedics Morris Plains, NJ CLL (see also lymphoma) Phase I/II (973) 605-8200 Vidaza® azacitidine (Orphan Drug) Celgene Summit, NJ AML in the elderly (see also lymphoma) Phase III (908) 673-9000 vosaroxin (Orphan Drug) Sunesis Pharmaceuticals South San Francisco, CA second-line AML (Fast Track) (see also ovarian) -------------------------------------------------AML in the elderly Phase III (650) 266-3739 ------------------------------------------Phase II (650) 266-3739 XmAb® 5574 (MOR208, anti-CD19 mAb) MorphoSys Planegg, Germany Xencor Monrovia, CA recurrent CLL Phase I www.morphosys.com (626) 305-5900 Zolinza® vorinostat Merck Whitehouse Station, NJ AML, myelodysplastic syndromes (see also breast, lung, lymphoma, multiple myeloma, other) Phase II (800) 672-6273 38 Medicines in Development Cancer 2012 Medicines in Development for Cancer Liver Cancer Product Name Sponsor ALN-VSP Alnylam Pharmaceuticals Cambridge, MA bavituximab Peregrine Pharmaceuticals Tustin, CA (see also lung, pancreatic) Phase I/II (715) 508-6000 BAY 86-9766 (MEK inhibitor) Ardea Biosciences San Diego, CA Bayer HealthCare Pharmaceuticals Wayne, NJ first-line liver cancer (combination therapy) (see also pancreatic) Phase II (888) 842-2937 belinostat Spectrum Pharmaceuticals Henderson, NV inoperable/unresectable liver cancer (see also colorectal, leukemia, lung, lymphoma, ovarian, other) Phase I/II (702) 835-6300 BIIB 022 Biogen Idec Cambridge, MA (see also lung) Phase I completed (617) 679-2000 brivanib (VEGFR/FGFR kinase inhibitor) Bristol-Myers Squibb Princeton, NJ first-line liver cancer, liver cancer (TACE) (see also colorectal, sarcoma) Phase III (800) 332-2056 cixutumumab (LY3012217/IMC-A12) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ (see also lung) Phase II (800) 545-5979 darinaparsin (ZIO-101) ZIOPHARM Oncology New York, NY (see also lymphoma, multiple myeloma, solid tumors) Phase II (646) 214-0700 DC Bead® doxorubicin-eluting beads Bayer HealthCare Pharmaceuticals Wayne, NJ Biocompatibles Surrey, United Kingdom E7050 Eisai Woodcliff Lake, NJ (see also brain, head/neck, skin, solid tumors, stomach) Phase I/II (888) 422-4743 foretinib (GSK1363089) GlaxoSmithKline Rsch. Triangle Park, NC (see also head/neck, kidney, lung) Phase I (888) 825-5249 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA (see also breast, colorectal, leukemia, lung, multiple myeloma, pancreatic, prostate, skin, stomach) Phase II (781) 274-8200 Inlyta® axitinib Pfizer New York, NY (see also kidney, other) Phase II (860) 732-5156 irinotecan eluting beads Biocompatibles International Surrey, United Kingdom liver metastases from colorectal cancer Phase II www.biocompatibles.com Medicines in Development Cancer 2012 Indication Development Status Phase I (617) 551-8200 Phase II (888) 842-2937 39 Medicines in Development for Cancer Liver Cancer Product Name Sponsor Indication Development Status JX-594 (pexastimogene devacirepvec) (Orphan Drug) Jennerex Biotherapeutics San Francisco, CA (see also colorectal) Phase II (415) 281-8886 lansoprazole (Orphan Drug) Apricus Biosciences San Diego, CA first-line liver cancer Phase II (858) 220-8041 linifanib Abbott Laboratories Abbott Park, IL first-line liver cancer (monotherapy) (see also breast, colorectal, kidney, lung) Phase III (847) 937-6100 mapatumumab Human Genome Sciences Rockville, MD liver cancer (combination therapy) (see also lung, multiple myeloma) Phase II (301) 309-8504 MB07133 (HepDirect HepB inhibitor) Ligand Pharmaceuticals La Jolla, CA inoperable/unresectable liver cancer Phase I/II completed (858) 550-7500 melphalan drug delivery system Delcath Systems New York, NY inoperable/unresectable liver cancer application submitted (212) 489-2100 muparfostat (PI-88) Progen Pharmaceuticals Queensland, Australia liver cancer (Fast Track) (see also skin) Phase III www.progen.com.au Nexavar® sorafenib (Orphan Drug) Bayer HealthCare Pharmaceuticals Wayne, NJ heptocellular carcinoma (adjuvant therapy) (see also breast, colorectal, head/neck, kidney, leukemia, lung, multiple myeloma, ovarian, other) Phase III (888) 842-2937 NV-1020 Catherex Philadelphia, PA OBP-301 Oncolys Biopharma Tokyo, Japan (see also breast, head/neck, lung) Phase I www.oncolys.com PEG arginine deiminase (ADI-PEG 20) Polaris Pharmaceuticals San Diego, CA hepatocellular carcinoma (see also prostate, skin, other) Phase III (858) 452-6688 PHY906 PhytoCeutica New Haven, CT (see also colorectal, pancreatic, cancer-related) Phase I/II completed (203) 777-3462 PV-10 (rose bengal sodium) (Orphan Drug) Provectus Pharmaceuticals Knoxville, TN liver cancer, liver metastases (see also skin) Phase I (866) 594-5999 RG7686 Roche Nutley, NJ metastatic liver cancer (combination therapy) Phase II (973) 235-5000 40 Phase I/II completed Medicines in Development Cancer 2012 Medicines in Development for Cancer Liver Cancer Product Name Sponsor Indication Development Status Tarceva® erlotinib Genentech South San Francisco, CA OSI Pharmaceuticals Farmingdale, NY first-line inoperable/unresectable liver cancer (combination therapy) (see also brain, breast, head/neck, leukemia, lung, other) -------------------------------------------------second-line liver cancer (combination therapy) Phase III (800) 626-3553 (631) 962-0600 TGF-ß R1 inhibitor (LY2157299) Eli Lilly Indianapolis, IN (see also brain) Phase II (800) 545-5979 ThermoDox® doxorubicin liposomal (Orphan Drug) Celsion Lawrenceville, NJ first-line inoperable/unresectable liver cancer (Fast Track) (see also breast, colorectal) Phase III (609) 896-9100 tigatuzumab (anti-DR5 antibody) Daiichi Sankyo Parsippany, NJ (see also breast, colorectal, lymphoma, ovarian, pancreatic) Phase II (973) 944-2600 tivantinib (ARQ 197) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ second-line liver cancer (see also colorectal, kidney, lung, pancreatic, sarcoma, other) -------------------------------------------------liver cancer (combination therapy) Phase II (781) 994-0300 (973) 944-2600 -----------------------------------------Phase I (781) 994-0300 (973) 944-2600 trebananib (AMG386) Amgen Thousand Oaks, CA (see also breast, colorectal, kidney, ovarian, stomach, other) Phase II (800) 772-6436 Xeloda® capecitabine Genentech South San Francisco, CA biliary cancer (combination therapy) (see also brain, colorectal, stomach) Phase II (800) 626-3553 Zadaxin® thymalfasin alfa 1 (Orphan Drug) SciClone Pharmaceuticals Foster City, CA (see also skin) Phase II/III (650) 358-3456 Medicines in Development Cancer 2012 ------------------------------------------Phase II (800) 626-3553 (631) 962-0600 41 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status Abraxane® albumin-bound paclitaxel Celgene Summit, NJ first-line non-small-cell lung cancer (NSCLC) (see also bladder, breast, ovarian, pancreatic, skin) application submitted (908) 673-9000 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL NSCLC (see also brain, breast, colorectal, lymphoma, ovarian, prostate, skin, other) Phase II (847) 937-6100 AC480 (pan-HER inhibitor) Ambit Biosciences San Diego, CA NCSLC (see also brain, breast) Phase I (858) 334-2100 Actimid® pomalidomide Celgene Summit, NJ small-cell lung cancer (SCLC) (see also lymphoma, multiple myeloma, pancreatic) Phase I/II (908) 673-9000 afatinib (BIBW2992) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT first-line NSCLC (see also brain, breast, head/neck) -------------------------------------------------second-line NSCLC (Fast Track) Phase III (800) 243-0127 ------------------------------------------Phase II/III (800) 243-0127 Alimta® pemetrexed Eli Lilly Indianapolis, IN first-line and maintenance NSCLC Phase III (800) 545-5979 AMG888/U3-1287 (anti-HER3 antibody) Amgen Thousand Oaks, CA Daiichi Sankyo Parsippany, NJ NSCLC Phase II (800) 772-6436 (973) 944-2600 amrubicin (Orphan Drug) Celgene Summit, NJ SCLC (Fast Track) (see also breast) -------------------------------------------------first-line SCLC Phase III (908) 673-9000 ------------------------------------------Phase II (908) 673-9000 amuvatinib (MP470) Astex Pharmaceuticals Dublin, CA SCLC (combination therapy) (see also lymphoma) Phase II (925) 560-0100 anti-PD1 (BMS-936558) Bristol-Myers Squibb Princeton, NJ (see also kidney, skin) Phase II (800) 332-2056 AP26113 ARIAD Pharmaceuticals Cambridge, MA NSCLC Phase I (617) 494-0400 apricoxib (TG01) Tragara Pharmaceuticals San Diego, CA second-line NSCLC (combination therapy) (see also pancreatic) Phase II (858) 350-6900 42 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status astuprotimut-R (MAGE-A3 antigen-specific cancer immunotherapeutic) GlaxoSmithKline Rsch. Triangle Park, NC adjuvant NSCLC (see also skin) Phase III (888) 825-5249 AT-101 (oral pan Bcl-2 inhibitor) Ascenta Therapeutics Malvern, PA NSCLC (combination therapy), SCLC (combination therapy) (see also brain, leukemia, lymphoma, prostate, stomach) Phase II (610) 408-0301 AUY922 (Hsp90 inhibitor) Novartis Pharmaceuticals East Hanover, NJ third-line NSCLC (see also breast, colorectal, multiple myeloma, stomach) -------------------------------------------------second-line late-stage NSCLC (combination therapy) Phase II (888) 669-6682 ------------------------------------------Phase I/II (888) 669-6682 Avastin® bevacizumab Genentech South San Francisco, CA adjuvant NSCLC (see also brain, breast, colorectal, ovarian, other) Phase III (800) 626-3553 bavituximab Peregrine Pharmaceuticals Tustin, CA first-line NSCLC, second-line NSCLC (see also liver, pancreatic) Phase II (715) 508-6000 belinostat Spectrum Pharmaceuticals Henderson, NV mesothelioma (see also colorectal, leukemia, liver, lymphoma, ovarian, other) -------------------------------------------------NSCLC Phase II completed (702) 835-6300 -------------------------------------------------SCLC ------------------------------------------Phase I/II (702) 835-6300 ------------------------------------------Phase I (702) 835-6300 BIIB 022 Biogen Idec Cambridge, MA NSCLC (see also liver) Phase I completed (617) 679-2000 BKM120 (PI3K inhibitor) Novartis Pharmaceuticals East Hanover, NJ late-stage NSCLC (see also brain, breast, other) Phase II (888) 669-6682 cabozantinib (XL184) Exelixis South San Francisco, CA NSCLC (see also breast, kidney, ovarian, prostate, other) Phase I/II (650) 837-7000 CBP-501 (peptide mimetic) CanBas Shizouka, Japan mesothelioma (combination therapy), first-line NSCLC (combination therapy) (see also solid tumors) Phase II www.canbas.co.jp Medicines in Development Cancer 2012 43 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status CC-223 (mTOR inhibitor) Celgene Summit, NJ NSCLC (see also lymphoma, multiple myeloma) Phase I (908) 673-9000 CEP-9722 (PARP inhibitor) Cephalon Frazer, PA NSCLC (combination therapy) (see also lymphoma) Phase II (610) 344-0200 Chk1 inhibitor (LY2603618) Eli Lilly Indianapolis, IN NSCLC (see also pancreatic) Phase II (800) 545-5979 cixutumumab (LY3012217/IMC-A12) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ NSCLC (see also liver) Phase II (800) 545-5979 CLR1404-I-124 Novelos Therapeutics Madison, WI NSCLC (diagnosis) Phase I/II (608) 441-8120 CLR1404-I-131 Novelos Therapeutics Madison, WI NSCLC (diagnosis) Phase I/II (608) 441-8120 CO-1686 (EGFR inhibitor) Clovis Oncology Boulder, CO second-line NSCLC Phase I/II (303) 625-5000 custirsen (OGX-001/TV-1011) OncoGenex Pharmaceuticals Bothell, WA Teva Pharmaceuticals Tikva, Israel first-line NSCLC (see also prostate) Phase II (425) 686-1500 dacomitinib (PF-00299804) Pfizer New York, NY NSCLC (see also solid tumors) Phase III (860) 732-5156 dalotuzumab (MK-0646) Merck Whitehouse Station, NJ recurrent NSCLC (combination therapy) (see also breast, pancreatic, other) Phase II (800) 672-6372 EC20 (technetium Tc-99m etarfolatide) Endocyte West Lafayette, IN NSCLC (diagnosis) (see also ovarian) Phase II www.endocyte.com EC145 (vintafolide) Endocyte West Lafayette, IN Merck Whitehouse Station, NJ NSCLC (see also ovarian) Phase II www.endocyte.com (800) 672-6372 efatutazone Daiichi Sankyo Parsippany, NJ NSCLC (see also colorectal, other) Phase II (973) 944-2600 elesclomol Synta Pharmaceuticals Lexington, MA NSCLC (see also leukemia, ovarian) Phase I/II (781) 274-8200 44 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status emepepimut-S EMD Serono Rockland, MA Oncothyreon Seattle, WA NSCLC (Fast Track) (see also prostate) Phase III (800) 283-8088 entinostat Syndax Pharmaceuticals Waltham, MA NSCLC (combination therapy) (see also breast, colorectal, kidney, leukemia, lymphoma) Phase II (781) 419-1400 ficlatuzumab (AV-299) AVEO Pharmaceuticals Cambridge, MA NSCLC (combination therapy) (see also solid tumors) Phase II (617) 299-5000 Folotyn® pralatrexate Allos Therapeutics Westminster, CO NSCLC (see also bladder, breast, lymphoma) Phase II (303) 426-6262 foretinib (GSK1363089) GlaxoSmithKline Rsch. Triangle Park, NC NSCLC (see also head/neck, kidney, liver) Phase I/II (888) 825-5249 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA second-line NSCLC (combination therapy) (see also breast, colorectal, leukemia, liver, multiple myeloma, pancreatic, prostate, skin, stomach) -------------------------------------------------SCLC Phase II/III (781) 274-8200 ------------------------------------------Phase II (781) 274-8200 ganitumab (AMG 479) Amgen Thousand Oaks, CA first-line SCLC (combination therapy) (see also breast, colorectal, pancreatic, sarcoma) Phase I/II (800) 772-6436 GI-4000 (cancer vaccine) GlobeImmune Louisville, CO NSCLC (see also colorectal, pancreatic) Phase I (303) 625-2700 Gleevec® imatinib Novartis Pharmaceuticals East Hanover, NJ NSCLC (combination therapy) (see also prostate, skin, other) Phase II (888) 669-6682 GSK2118436 (BRaf protein kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC BRAF mutation-positive disease NSCLC (see also brain, skin) Phase II (888) 825-5249 Halaven® eribulin Eisai Woodcliff Lake, NJ NSCLC (see also prostate, sarcoma) Phase III (888) 422-4743 HS-110 (cancer vaccine) Heat Biologics Chapel Hill, NC late-stage NSCLC (combination therapy) Phase I (919) 240-7133 Medicines in Development Cancer 2012 45 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status HyperAcute® Lung lung cancer immunotherapy NewLink Genetics Ames, IA metastatic NSCLC Phase II (515) 296-5555 IDM-2101 (multi-epitope cancer vaccine) Biotech Synergy San Diego, CA NSCLC Phase II (858) 459-6689 imetelstat Geron Menlo Park, CA late-stage NSCLC (see also breast, leukemia, multiple myeloma) Phase II (650) 473-7700 IMO-2055 (TLR9 agonist) Idera Pharmaceuticals Cambridge, MA (see also colorectal, head/neck) Phase I (617) 679-5000 Imprime PGG® Biothera Eagan, MN NSCLC (see also colorectal, leukemia, skin) Phase II (651) 675-0300 iniparib (BSI-201) Sanofi US Bridgewater, NJ squamous NSCLC (see also breast, ovarian) -------------------------------------------------non-squamous NSCLC Phase III (800) 981-2491 ------------------------------------------Phase II (800) 981-2491 Iressa® gefitinib AstraZeneca Wilmington, DE first-line EGFR mutation-positive NSCLC Phase III (800) 236-9933 ISIS-EIF4ERx Isis Pharmaceuticals Carlsbad, CA late-stage NSCLC (combination therapy) (see also prostate) Phase II (800) 679-4747 JNJ-26854165 (Hdm2 inhibitor) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ NSCLC (see also prostate, solid tumors) Phase I (800) 817-5286 Karenitecin® BNP1350 BioNumerik Pharmaceuticals San Antonio, TX NSCLC (see also ovarian, solid tumors) Phase II (210) 614-1701 KD019 (SSKI inhibitor) Kadmon Pharmaceuticals Warrendale, PA late-stage NSCLC Phase III (724) 778-6100 KD032 (ras/mTOR inhibitor) Kadmon Pharmaceuticals Warrendale, PA NSCLC (see also pancreatic) Phase II completed (724) 778-6100 linifanib Abbott Laboratories Abbott Park, IL NSCLC (see also breast, colorectal, kidney, liver) Phase II (847) 937-6100 litronesib (LY2523355) Eli Lilly Indianapolis, IN NSCLC (see also breast) Phase II (800) 545-5979 46 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status lorvotuzumab mertansine (IMGN901) (Orphan Drug) ImmunoGen Waltham, MA SCLC (see also multiple myeloma) Phase II (781) 895-0600 Lucanix® belagenpumatucel-L NovaRx San Diego, CA NSCLC (Fast Track) (see also brain) Phase III (858) 522-8600 mapatumumab Human Genome Sciences Rockville, MD NSCLC (combination therapy) (see also liver, multiple myeloma) Phase II (301) 309-8504 MEDI-575 (anti-PDGFR-alpha mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD NSCLC (see also brain) Phase II (800) 236-9933 (301) 398-0000 MGCD265 (multi-kinase inhibitor) MethylGene Montreal, Canada NSCLC (combination therapy) Phase I/II (514) 337-3333 MORAb-003 (farletuzumab) Eisai Woodcliff Lake, NJ NSCLC (see also ovarian) Phase II (888) 422-4743 MORAb-009 (amatuximab) Eisai Woodcliff Lake, NJ mesothelioma Phase II (888) 422-4743 motesanib Amgen Thousand Oaks, CA NSCLC (see also breast, colorectal, other) Phase III (800) 772-6436 naptumomab estafenatox Active Biotech Lund, Sweden NSCLC (Fast Track) (see also kidney, pancreatic) Phase I completed www.activebiotech.com navitoclax (ABT-263) Abbott Laboratories Abbott Park, IL NSCLC, SCLC (see also leukemia, lymphoma) Phase II (847) 937-6100 necitumumab (IMC-11F8) Bristol-Myers Squibb Princeton, NJ Eli Lilly Indianapolis, IN ImClone Systems Bridgewater, NJ NSCLC Phase III (800) 332-2056 (800) 545-5979 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ NSCLC (see also breast, colorectal, head/neck, kidney, leukemia, liver, multiple myeloma, ovarian, other) Phase III (888) 842-2937 Medicines in Development Cancer 2012 47 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status NGR-hTNF (Orphan Drug) MolMed Milan, Italy second-line mesothelioma Phase III www.molmed.com NK-012 Nippon Kayaku Tokyo, Japan SCLC (see also breast) Phase II www.nipponkayaku.co.jp NTX-010 Neotropix Malvern, PA SCLC (see also other) Phase II www.neotropix.com obatoclax Cephalon Frazer, PA first-line SCLC (see also leukemia, lymphoma, multiple myeloma) Phase II (610) 344-0200 OBP-301 Oncolys Biopharma Tokyo, Japan mesothelioma (see also breast, head/neck, liver) Phase I www.oncolys.com OGX-427 OncoGenex Pharmaceuticals Bothell, WA NSCLC (see also breast, ovarian) Phase I (425) 686-1500 ombrabulin (AVE8062) Sanofi US Bridgewater, NJ first-line NSCLC (see also ovarian, sarcoma) Phase II (800) 981-2491 onartuzumab Genentech South San Francisco, CA metastatic NSCLC (see also breast, colorectal) Phase III (800) 626-3553 Oncoprex™ (TUSC2/FUS1 gene therapy) Genprex Austin, TX NSCLC Phase I (512) 597-5900 Opaxio™ paclitaxel poliglumex Cell Therapeutics Seattle, WA NSCLC (see also brain, ovarian, stomach, other) Phase III (800) 215-2355 oral azacitidine Celgene Summit, NJ NSCLC (see also leukemia, lymphoma, solid tumors) Phase I (908) 673-9000 OSI-906 (IGF-1R/1R tyrosinase kinase inhibitor) OSI Pharmaceuticals Farmingdale, NY NSCLC (see also ovarian, other) Phase II (631) 962-0600 P2045 Bryan Oncor Somerville, MA NSCLC, SCLC Phase I completed palifosfamide (ZIO-201) ZIOPHARM Oncology New York, NY SCLC (see also sarcoma, solid tumors) Phase I (646) 214-0700 48 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status pegdinetanib (VEGFR-2 adnectin) (BMS-844203) Bristol-Myers Squibb Princeton, NJ NSCLC Phase II (800) 332-2056 perifosine AEterna Zentaris Basking Ridge, NJ NSCLC (see also brain, colorectal, kidney, leukemia, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach) Phase I/II (908) 626-5428 picoplatin (Orphan Drug) Ponaird Pharmaceuticals Seattle, WA second-line SCLC (Fast Track) (see also colorectal, ovarian, prostate) Phase II (206) 281-7001 plinabulin (NPI-2358) Nereus Pharmaceuticals San Diego, CA NSCLC Phase II (858) 587-4090 PRAME antigen-specific cancer immunotherapeutic (recombinant) GlaxoSmithKline Rsch. Triangle Park, NC NSCLC (see also skin) Phase I (888) 825-5349 PT107 (allogeneic tumor cell vaccine) Pique Therapeutics Durham, NC NSCLC Phase II (919) 806-4395 PX-866 Oncothyreon Seattle, WA NSCLC (combination therapy) (see also brain, head/neck, prostate) Phase II (206) 801-2100 ranpirnase Tamir Biotechnology Monmouth Junction, NJ NSCLC Phase II (732) 823-1003 regorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ NSCLC (see also colorectal, kidney, solid tumors, stomach) Phase I (888) 842-2837 Reolysin® reovirus Oncolytics Biotech Calgary, Canada NSCLC (combination therapy) (see also brain, colorectal, head/neck, ovarian, pancreatic, sarcoma, skin, solid tumors) Phase II (403) 670-7377 retaspimycin Infinity Pharmaceuticals Cambridge, MA NSCLC Phase II (617) 453-1000 RG7414 (EGFL7 inhibitor) Genentech South San Francisco, CA NSCLC (see also colorectal) Phase II (800) 626-3553 Medicines in Development Cancer 2012 49 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status RG7599 (antibody drug conjugate) Genentech South San Francisco, CA NSCLC (see also ovarian) Phase I (800) 626-3553 ridaforolimus ARIAD Pharmaceuticals Cambridge, MA Merck Whitehouse Station, NJ NSCLC (see also breast, kidney, prostate, sarcoma, other) Phase II (800) 672-6372 sapacitabine (CYC682) Cyclacel Pharmaceuticals Berkeley Heights, NJ NSCLC (see also leukemia, solid tumors) Phase II (908) 517-7330 SAR256212 (MM-121) (anti-ErbB3 mAb) Merrimack Pharmaceuticals Cambridge, MA Sanofi US Bridgewater, NJ NSCLC (see also breast, ovarian) Phase II (800) 981-2491 talactoferrin alfa (oral) (Orphan Drug) Agennix Princeton, NJ NSCLC (Fast Track) Phase III (609) 524-1000 tamibarotene CytRx Los Angeles, CA NSCLC (see also leukemia) Phase II (310) 826-5648 Tarceva® erlotinib Genentech South San Francisco, CA OSI Pharmaceuticals Farmingdale, NY adjuvant NSCLC (see also brain, breast, head/neck, leukemia, liver, other) Phase III (800) 626-3553 (631) 962-0600 Tavocept® dimesna BioNumerik Pharmaceuticals San Antonio, TX (see also cancer-related) Phase III (210) 614-1701 Tc-99m ethylenedicysteine glucosamine (EC-G) Cell Point Centennial, CO NSCLC (diagnosis) Phase II/III (303) 689-9693 Telcyta™ canfosfamide Telik Palo Alto, CA third-line NSCLC (see also lymphoma, ovarian) Phase III completed (650) 845-7700 Temodar® temozolomide Merck Whitehouse Station, NJ SCLC (see also leukemia) Phase II (800) 672-6372 tivantinib (ARQ 197) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ NSCLC (see also colorectal, kidney, liver, pancreatic, sarcoma, other) Phase III (781) 994-0300 (973) 944-2600 50 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lung Cancer Product Name Sponsor Indication Development Status topotecan liposomes injection Talon Therapeutics San Mateo, CA SCLC (see also ovarian) Phase I (650) 599-6404 trametinib GlaxoSmithKline Rsch. Triangle Park, NC second-line NSCLC (see also leukemia, lymphoma, multiple myeloma, pancreatic, skin) Phase II (888) 825-5249 Vargatef™ intedanib Boehringer Ingelheim Pharmaceuticals Ridgefield, CT second-line late-stage NSCLC (combination therapy) (see also ovarian) Phase III (800) 243-0127 veglin (VEGF antisense) VasGene Therapeutics Los Angeles, CA mesothelioma (see also kidney, skin) Phase I (323) 221-7818 volociximab Abbott Laboratories Abbott Park, IL Biogen Idec Weston, MA NSCLC Phase II (847) 937-6100 (781) 464-2000 Xalkori® crizotinib (Orphan Drug) Pfizer New York, NY first-line ALK-positive NSCLC, second-line ALK-positive NSCLC (see also solid tumors) -------------------------------------------------NSCLC (combination therapy) Phase III (860) 732-5156 YERVOY® ipilimumab Bristol-Myers Squibb Princeton, NJ NSCLC, SCLC (see also prostate, skin) in clinical trials (800) 332-2056 Zolinza® vorinostat (Orphan Drug) Merck Whitehouse Station, NJ mesothelioma (see also breast, leukemia, lymphoma, multiple myeloma, other) Phase III (800) 672-6273 Zybrestat™ fosbretabulin OXiGENE South San Francisco, CA first-line NSCLC (see also ovarian) Phase II (650) 635-7000 Medicines in Development Cancer 2012 ------------------------------------------Phase I/II (860) 732-5156 51 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status abexinostat (HDAC inhibitor) Pharmacyclics Sunnyvale, CA lymphoma (see also sarcoma) Phase I/II (408) 774-0330 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL (see also brain, breast, colorectal, lung, ovarian, prostate, skin, other) Phase I/II (847) 937-6100 Actimid® pomalidomide Celgene Summit, NJ Waldenström’s macroglobulinemia (see also lung, multiple myeloma, pancreatic) Phase I (908) 673-9000 Adcetris™ brentuximab vedotin Millennium Pharmaceuticals Cambridge, MA Seattle Genetics Bothell, WA post-transplant Hodgkin’s lymphoma relapse prevention (see also leukemia) -------------------------------------------------relapsed/refractory CD30-positive non-Hodgkin’s lymphoma, relapsed/ refractory anaplastic large-cell lymphoma -------------------------------------------------first-line anaplastic large-cell lymphoma, first-line Hodgkin’s lymphoma Phase III (800) 390-5663 (425) 527-4000 ------------------------------------------Phase II (800) 390-5663 (425) 527-4000 ------------------------------------------Phase I (800) 390-5663 (425) 527-4000 Adcetris™ Companion Diagnostic brentuximab vedotin companion diagnostic Millennium Pharmaceuticals Cambridge, MA Seattle Genetics Bothell, WA Ventana Medical Systems Tucson, AZ cutaneous T-cell lymphoma (diagnosis), T-cell lymphoma (diagnosis) in clinical trials (617) 679-7000 (425) 527-4000 (800) 227-2155 AEG35156 (XIAP inhibitor) Aegera Therapeutics Montreal, Canada B-cell lymphoma (see also leukemia) Phase I/II (514) 288-5532 AEZS-112 AEterna Zentaris Basking Ridge, NJ (see also solid tumors) Phase I (908) 626-5428 Afinitor® everolimus Novartis Pharmaceuticals East Hanover, NJ mantle cell lymphoma (see also breast, kidney) Phase II (888) 669-6682 AFM13 Affimed Therapeutics Heidelberg, Germany second-line Hodgkin’s disease Phase I www.affimed.com Alocrest™ vinorelbine liposomal Talon Therapeutics San Mateo, CA non-Hodgkin’s lymphoma (see also solid tumors) Phase I (650) 588-6404 52 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status AME-133v (ocaratuzumab) MENTRIK Biotech Dallas, TX non-Hodgkin’s lymphoma Phase II completed (214) 593-0500 Amplimexon® imexon AmpliMed Tucson, AZ second-line non-Hodgkin’s lymphoma Phase II (520) 529-1000 amuvatinib (MP470) Astex Pharmaceuticals Dublin, OH (see also lung) Phase I (925) 560-0100 anti-CD22 mAb Abiogen Pharma Pisa, Italy B-cell lymphoma Phase I www.abiogen.com Aplidin® plitidepsin PharmaMar Madrid, Spain (see also multiple myeloma, solid tumors) Phase I www.pharmamar.com AR-12 Arno Therapeutics Flemington, NJ (see also solid tumors) Phase I (862) 703-7170 AR-42 Arno Therapeutics Flemington, NJ (see also leukemia, multiple myeloma) Phase I/II (862) 703-7170 Arranon® nelarabine (Orphan Drug) GlaxoSmithKline Rsch. Triangle Park, NC first-line T-cell lymphoma (see also leukemia) -------------------------------------------------second-line T-cell lymphoma Phase III (888) 669-6682 ------------------------------------------Phase I/II (888) 669-6682 Arzerra® ofatumumab GlaxoSmithKline Rsch. Triangle Park, NC second-line diffuse large B-cell lymphoma, second-line follicular lymphoma (see also leukemia) -------------------------------------------------Waldenström’s macroglobulinemia Phase III (888) 825-5249 ------------------------------------------Phase II (888) 825-5249 ASP3026 Astellas Pharma US Deerfield, IL late-stage B-cell lymphoma (see also solid tumors) Phase I (800) 695-4321 AT-101 (oral pan Bcl-2 inhibitor) Ascenta Therapeutics Malvern, PA non-Hodgkin’s lymphoma (see also brain, leukemia, lung, prostate, stomach) Phase II (610) 408-0301 AT-406/Debio-1143 Ascenta Therapeutics Malvern, PA Debiopharm Lausanne, Switzerland lymphoma (see also leukemia) Phase I (610) 408-0301 www.debiopharm.com Medicines in Development Cancer 2012 53 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status AT7519 (CDK inhibitor) Astex Pharmaceuticals Dublin, CA mantle cell lymphoma (see also leukemia, multiple myeloma, solid tumors) Phase II (925) 560-0100 AT9283 (aurora/Jak2 inhibitor) Astex Pharmaceuticals Dublin, CA non-Hodgkin’s lymphoma (see also leukemia, multiple myeloma, solid tumors) Phase I (925) 560-0100 autologous cancer vaccine Bayer Innovation Dusseldorf, Germany Stellar Biotechnologies Port Hueneme, CA follicular lymphoma (prevention of relapse) Phase I (888) 842-2937 (805) 488-2800 AVL-292 (Btk inhibitor) Celgene Summit, NJ second-line non-Hodgkin’s lymphoma, second-line Waldenström’s macroglobulinemia (see also leukemia, unspecified) Phase I (908) 673-9000 Bcl-2 inhibitor (ABT-199/GDC-0199) Abbott Laboratories Abbott Park, IL Genentech South San Francisco, CA non-Hodgkin’s lymphoma (see also leukemia) Phase I (847) 937-6100 (800) 626-3553 belinostat (Orphan Drug) Spectrum Pharmaceuticals Henderson, NV peripheral T-cell lymphoma (PTCL) (Fast Track) (see also colorectal, leukemia, liver, lung, ovarian, other) Phase II (702) 835-6300 Bexxar® tositumomab and iodine I-131 tositumomab GlaxoSmithKline Rsch. Triangle Park, NC mantle cell lymphoma (combination therapy) Phase II (888) 825-5249 BiovaxID® B-cell lymphoma vaccine (personalized lymphoma vaccine) BioVest International Tampa, FL indolent follicular lymphoma (Fast Track) -------------------------------------------------mantle cell lymphoma Phase III (813) 864-2554 ------------------------------------------Phase II (813) 864-2554 CC-115 (kinase inhibitor) Celgene Summit, NJ non-Hodgkin’s lymphoma (see also multiple myeloma, solid tumors) Phase I (908) 673-9000 CC-122 Celgene Summit, NJ non-Hodgkin’s lymphoma (see also multiple myeloma, solid tumors) Phase I (908) 673-9000 CC-223 (mTOR inhibitor) Celgene Summit, NJ non-Hodgkin’s lymphoma (see also lung, multiple myeloma) Phase I (908) 673-9000 CEP-9722 (PARP inhibitor) Cephalon Frazer, PA mantle cell lymphoma (combination therapy) (see also lung) Phase I (610) 344-0200 54 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status Clearazide™ mechlorethamine gel (Orphan Drug) Ceptaris Therapeutics Malvern, PA cutaneous T-cell lymphoma (Fast Track) application submitted (610) 975-9290 CT-011 CureTech Yavne, Israel diffuse large B-cell lymphoma, second-line follicular lymphoma (combination therapy) (see also colorectal, leukemia) Phase II www.curetechbio.com darinaparsin (ZIO-101) (Orphan Drug) ZIOPHARM Oncology New York, NY second-line peripheral T-cell lymphoma (see also liver, multiple myeloma, solid tumors) -------------------------------------------------first-line peripheral T-cell lymphoma (combination therapy), non-Hodgkin’s lymphoma Phase II (646) 214-0700 ------------------------------------------Phase I (646) 214-0700 DCDS-4501A Genentech South San Francisco, CA non-Hodgkin’s lymphoma (see also leukemia) Phase I (800) 626-3553 DCDT-2980S Genentech South San Francisco, CA recurrent non-Hodgkin’s lymphoma (see also leukemia) Phase I (800) 626-3553 DI-Leu16-IL2 Alopexx Oncology Waltham, MA non-Hodgkin’s lymphoma Phase I (781) 497-9888 entinostat Syndax Pharmaceuticals Waltham, MA Hodgkin’s disease (see also breast, colorectal, kidney, leukemia, lung) Phase II (781) 419-1400 enzastaurin Eli Lilly Indianapolis, IN diffuse large B-cell lymphoma Phase III (800) 545-5979 epratuzumab (Orphan Drug) Immunomedics Morris Plains, NJ UCB Atlanta, GA diffuse large B-cell lymphoma (combination therapy), follicular lymphoma (combination therapy) (see also leukemia) Phase II (973) 605-8200 epratuzumab Y-90 Immunomedics Morris Plains, NJ diffuse large B-cell lymphoma Phase II (973) 605-8200 ------------------------------------------Phase I/II (973) 605-8200 Medicines in Development Cancer 2012 -------------------------------------------------recurrent non-Hodgkin’s lymphoma 55 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status EZN-2968 (HIF1-alpha inhibitor) Enzon Pharmaceuticals Piscataway, NJ (see also solid tumors) Phase I (973) 980-4500 Folotyn® pralatrexate (Orphan Drug) Allos Therapeutics Westminster, CO peripheral T-cell lymphoma (first-line therapy) (see also bladder, breast, lung) -------------------------------------------------B-cell non-Hodgkin’s lymphoma, lymphoma (combination therapy) -------------------------------------------------cutaneous T-cell lymphoma Phase III (303) 426-6262 forodesine (Orphan Drug) BioCryst Pharmaceuticals Durham, NC cutaneous T-cell lymphoma (see also leukemia) Phase II (919) 859-1302 galiximab Biogen Idec Cambridge, MA non-Hodgkin’s lymphoma (combination therapy) -------------------------------------------------first-line non-Hodgkin’s lymphoma (monotherapy) Phase II completed (617) 679-2000 ------------------------------------------Phase I completed (617) 679-2000 GDC-0349 (small molecule) Genentech South San Francisco, CA non-Hodgkin’s lymphoma (see also solid tumors) Phase I (800) 626-3553 GDC-0425 (ChK1 inhibitor) Genentech South San Francisco, CA (see also solid tumors) Phase I (800) 626-3553 GDC-0575 Genentech South San Francisco, CA (see also solid tumors) Phase I (800) 626-3553 GDC-0917 (IAP antagonist) Genentech South San Francisco, CA (see also solid tumors) Phase I (800) 626-3553 GDC-0980 (PI3 kinase/mTOR dual inhibitor) Genentech South San Francisco, CA non-Hodgkin’s lymphoma (see also breast, solid tumors) Phase I (800) 626-3553 GS-1101 (PI3K delta inhibitor) Gilead Sciences Foster City, CA indolent non-Hodgkin’s lymphoma (see also leukemia) Phase II (800) 445-3235 GSK461364 (polio-like kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC non-Hodgkin’s lymphoma (see also solid tumors) Phase I (888) 825-5249 GSK690693 (AKT kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also solid tumors) Phase I (888) 825-5249 56 ------------------------------------------Phase II (303) 426-6262 ------------------------------------------Phase I (303) 426-6262 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status GSK2126458 (PI3K/mTOR inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also solid tumors) Phase I (888) 825-5249 GSK2141795 (protein kinase B inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also solid tumors) Phase I (888) 825-5249 iboctadekin GlaxoSmithKline Rsch. Triangle Park, NC non-Hodgkin’s lymphoma (combination therapy) (see also ovarian) Phase I completed (888) 825-5249 ibrutinib (PCI-32765) Janssen Biotech Horsham, PA Pharmacyclics Sunnyvale, CA diffuse large B-cell lymphoma, mantle cell lymphoma (see also leukemia, multiple myeloma) Phase II (800) 526-7736 (408) 774-0330 IMGN529 ImmunoGen Waltham, MA metastatic non-Hodgkin’s lymphoma Phase I (781) 895-0600 INK128 (mTOR inhibitor) Intellikine La Jolla, CA Waldenström’s macroglobulinemia (see also multiple myeloma, solid tumors) Phase I (858) 768-6500 inotuzumab ozogamicin Pfizer New York, NY aggressive non-Hodgkin’s lymphoma (see also leukemia) -------------------------------------------------diffuse large B-cell lymphoma, indolent non-Hodgkin’s lymphoma Phase III (860) 732-5156 ------------------------------------------Phase II (860) 732-5156 interleukin-12 gene therapy OncoSec Medical San Diego, CA cutaneous T-cell lymphoma (see also skin) Phase II www.oncosec.com ISF35 Memgen San Diego, CA follicular lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, small lymphocytic lymphoma (see also leukemia) Phase II (858) 524-5400 JNJ-26481585 (quisinostat) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ cutaneous T-cell lymphoma (see also leukemia) Phase II (800) 817-5286 LEE011 (CDK4/6 inhibitor) Novartis Pharmaceuticals East Hanover, NJ (see also solid tumors) Phase I (888) 669-6682 LG740 (activated T-cells) Lentigen Gaithersburg, MD University of Pennsylvania Philadelphia, PA diffuse large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma (see also leukemia) Phase I (301) 527-4200 Medicines in Development Cancer 2012 57 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status lucatumumab (HDC122) Novartis Pharmaceuticals East Hanover, NJ XOMA Berkeley, CA lymphoma Phase I/II (888) 669-6682 ------------------------------------------Phase I (888) 669-6682 Marqibo® vincristine liposomal Talon Therapeutics San Mateo, CA non-Hodgkin’s lymphoma (see also leukemia, skin, other) Phase II (650) 588-6404 milatuzumab Immunomedics Morris Plains, NJ non-Hodgkin’s lymphoma (see also leukemia, multiple myeloma) Phase I/II (973) 605-8200 MK-7956 (dinaciclib) Merck Whitehouse Station, NJ mantle cell lymphoma (see also leukemia) Phase II (800) 672-6372 MK-8808 Merck Whitehouse Station, NJ late-stage follicular lymphoma (combination therapy) Phase I (800) 672-6372 MLN8237 (alisertib) Millennium Pharmaceuticals Cambridge, MA peripheral T-cell lymphoma (see also solid tumors) Phase III (800) 390-5663 MLN9708 (ixazomib) Millennium Pharmaceuticals Cambridge, MA lymphoma, Waldenström’s macroglobulinemia (see also multiple myeloma, solid tumors) Phase I (800) 390-5663 mocetinostat (MGCD0103, HDAC inhibitor) (Orphan Drug) MethylGene Montreal, Canada diffuse large B-cell lymphoma, follicular lymphoma (see also leukemia, solid tumors) Phase II (514) 337-3333 mogamulizumab (Orphan Drug) Amgen Thousand Oaks, CA cutaneous T-cell lymphoma, peripheral T-cell lymphoma Phase II (800) 772-6436 navitoclax (ABT-263) Abbott Laboratories Abbott Park, IL (see also leukemia, lung) Phase I/II (847) 937-6100 NPI-0052 (marizomib) Nereus Pharmaceuticals San Diego, CA (see also multiple myeloma, solid tumors) Phase I (858) 587-4090 obatoclax (Orphan Drug) Cephalon Frazer, PA first-line follicular lymphoma (combination therapy) (see also leukemia, lung, multiple myeloma) -------------------------------------------------mantle cell lymphoma Phase II completed (610) 344-0200 58 -------------------------------------------------follicular lymphoma ------------------------------------------Phase I/II completed (610) 344-0200 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status obinutuzumab (GA101/RG7159) Biogen Idec Weston, MA Genentech South San Francisco, CA first-line non-Hodgkin’s lymphoma (combination therapy), second-line non-Hodgkin’s lymphoma (combination therapy), first-line B-cell lymphoma (combination therapy) (see also leukemia) -------------------------------------------------second-line non-Hodgkin’s lymphoma (monotherapy) Phase III (781) 464-2000 (800) 626-3553 ------------------------------------------Phase II (781) 464-2000 (800) 626-3553 ON 013105 Onconova Therapeutics Newtown, PA (see also leukemia) Phase I (267) 759-3680 ONO-4059 ONO Pharmaceutical Osaka, Japan B-cell lymphoma Phase I www.ono.co.jp oral azacitidine Celgene Summit, NJ (see also leukemia, lung, solid tumors) Phase I (908) 673-9000 OSI-027 (TORC1/TORC2 inhibitor) OSI Pharmaceuticals Farmingdale, NY (see also kidney) Phase I (631) 962-0600 P 27600 Piramal Life Sciences Mumbai, India mantle cell lymphoma Phase II www.piramallifesciences.com perifosine AEterna Zentaris Basking Ridge, NJ lymphoma (combination therapy), Waldenström’s macroglobulinemia (see also brain, colorectal, kidney, leukemia, lung, multiple myeloma, sarcoma, solid tumors, stomach) Phase II (908) 626-5428 PG11047 Progen Pharmaceuticals Queensland, Australia (see also solid tumors) Phase I www.progen-pharma.com pixantrone Cell Therapeutics Seattle, WA diffuse large B-cell lymphoma (see also breast) Phase III (800) 215-2355 PLX3397 (CSF-1R kinase inhibitor) Plexxikon Berkeley, CA recurrent or refractory Hodgkin’s disease (see also brain, leukemia, solid tumors) Phase II (510) 647-4000 Medicines in Development Cancer 2012 59 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status Revlimid® lenalidomide Celgene Summit, NJ non-Hodgkin’s lymphoma (see also leukemia) Phase III (908) 673-9000 RG7602 Genentech South San Francisco, CA (see also solid tumors) Phase I (800) 626-3553 rigosertib Onconova Therapeutics Newtown, PA (see also leukemia, ovarian, pancreatic) Phase II (267) 759-3680 Rituxan® rituxumab (fast infusion) Biogen Idec Weston, MA Genentech South San Francisco, CA non-Hodgkin’s lymphoma application submitted (781) 464-2000 (800) 626-3553 SAR245409 (XL765) (PI3K/mTOR inhibitor) Sanofi US Bridgewater, NJ Exelixis South San Francisco, CA non-Hodgkin’s lymphoma (see also breast) Phase II (800) 981-2491 (650) 837-7000 SGN-75 (vorsetuzumab mafodotin) Seattle Genetics Bothell, WA non-Hodgkin’s lymphoma (see also kidney) Phase I (425) 527-4000 SHP-141 Shape Pharmaceuticals Cambridge, MA cutaneous T-cell lymphoma Phase I www.shapepharma.com sotrastaurin (AEB071) Novartis Pharmaceuticals East Hanover, NJ diffuse large B-cell lymphoma Phase I (888) 669-6682 stem cell therapy Benitec Biopharma Sydney, Australia City of Hope National Medical Center Duarte, CA AIDS-related lymphoma Phase I www.benitec.com teglarinad Cephalon Frazer, PA (see also solid tumors) Phase I (610) 344-0200 Telcyta™ canfosfamide Telik Palo Alto, CA diffuse large B-cell lymphoma, mantle cell lymphoma, non-Hodgkin’s lymphoma (see also lung, ovarian) Phase II (650) 845-7700 thiarabine Access Pharmaceuticals Dallas, TX (see also leukemia) Phase I/II (215) 904-5100 60 Medicines in Development Cancer 2012 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status tigatuzumab (anti-DR5 antibody) Daiichi Sankyo Parsippany, NJ (see also breast, colorectal, liver, ovarian, pancreatic) Phase I completed (973) 944-2600 TKM-PLK1 (RNAi) Tekmira Pharmaceuticals Burnaby, Canada (see also solid tumors) Phase I (604) 419-3200 trametinib GlaxoSmithKline Rsch. Triangle Park, NC (see also leukemia, lung, multiple myeloma, pancreatic, skin) Phase I (888) 825-5249 Treanda® bendamustine Cephalon Frazer, PA first-line non-Hodgkin’s lymphoma (combination therapy) (see also leukemia, multiple myeloma) -------------------------------------------------second-line mantle cell lymphoma (combination therapy) application submitted (610) 344-0200 ------------------------------------------Phase II (610) 344-0200 TRU-016 (humanized anti-CD37 therapeutic) Emergent BioSolutions Rockville, MD non-Hodgkin’s lymphoma (see also leukemia) Phase I/II (301) 795-1800 UNBS-5162 Drais Pharmaceuticals Bridgewater, NJ (see also solid tumors) Phase I (908) 895-1200 Velcade® bortezomib Millennium Pharmaceuticals Cambridge, MA first-line mantle cell lymphoma (see also leukemia, cancer-related, other) -------------------------------------------------non-Hodgkin’s B-cell lymphoma Phase III (800) 390-5663 -------------------------------------------------diffuse large B-cell lymphoma ------------------------------------------Phase III (800) 390-5663 ------------------------------------------Phase II (800) 390-5663 veltuzumab Immunomedics Morris Plains, NJ non-Hodgkin’s lymphoma (see also leukemia) Phase I/II (973) 605-8200 Vidaza® azacitidine Celgene Summit, NJ (see also leukemia) Phase III (908) 673-9000 VTX-2337 VentiRx Pharmaceuticals Seattle, WA B-cell lymphoma (see also solid tumors) -------------------------------------------------lymphoma Phase I/II (206) 689-2259 ------------------------------------------Phase I (206) 689-2259 Medicines in Development Cancer 2012 61 Medicines in Development for Cancer Lymphoma Product Name Sponsor Indication Development Status XmAb®2513 (CD30-antigen inhibitor) Xencor Monrovia, CA Hodgkin’s disease, T-cell lymphoma Phase I (626) 305-5900 YM155 (sepantronium) Astellas Pharma US Deerfield, IL non-Hodgkin’s lymphoma (see also breast) Phase II (800) 695-4321 zanolimumab (Orphan Drug) Emergent BioSolutions Rockville, MD cutaneous T-cell lymphoma Phase II (301) 795-1800 ------------------------------------------Phase I (301) 795-1800 Zevalin® ibritumomab tiuxetan Spectrum Pharmaceuticals Henderson, NV second-line diffuse large B-cell lymphoma -------------------------------------------------mantle cell lymphoma Phase III (702) 835-6300 ------------------------------------------Phase II (702) 835-6300 Zolinza® vorinostat Merck Whitehouse Station, NJ B-cell lymphoma (see also breast, leukemia, lung, multiple myeloma, other) Phase II (800) 672-6273 -------------------------------------------------peripheral T-cell lymphoma Multiple Myeloma Product Name Sponsor Indication Development Status ACE-041 (dalantercept) Acceleron Pharma Cambridge, MA (see also head/neck) Phase I (617) 649-9200 Actimid® pomalidomide (Orphan Drug) Celgene Summit, NJ recurrent multiple myeloma (see also lung, lymphoma, pancreatic) application submitted (908) 673-9000 ACY-1215 (HDAC6 inhibitor) Acetylon Pharmaceuticals Boston, MA ALXN6000 (samalizumab) Alexion Pharmaceuticals Cheshire, CT 62 Phase I/II (617) 245-1300 (see also leukemia) Phase I/II completed (203) 272-2596 Medicines in Development Cancer 2012 Medicines in Development for Cancer Multiple Myeloma Product Name Sponsor Indication Development Status Aplidin® plitidepsin (Orphan Drug) PharmaMar Madrid, Spain (see also lymphoma, solid tumors) Phase III www.pharmamar.com AR-42 Arno Therapeutics Flemington, NJ (see also leukemia, lymphoma) Phase I/II (862) 703-7170 ARRY-520 (KSP inhibitor) Array BioPharma Boulder, CO multiple myeloma (see also leukemia, solid tumors) -------------------------------------------------multiple myeloma (combination therapy) Phase II (877) 633-2436 ------------------------------------------Phase I (877) 633-2436 AT7519 (CDK inhibitor) Astex Pharmaceuticals Dublin, CA second-line multiple myeloma (see also leukemia, lymphoma, solid tumors) Phase I/II (925) 560-0100 AT9283 (aurora/Jak2 inhibitor) Astex Pharmaceuticals Dublin, CA (see also leukemia, lymphoma, solid tumors) Phase II (925) 560-0100 AUY922 (Hsp90 inhibitor) Novartis Pharmaceuticals East Hanover, NJ (see also breast, colorectal, lung, stomach) Phase I/II (888) 669-6682 BHQ880 (mAb) Novartis Pharmaceuticals East Hanover, NJ (see also solid tumors) Phase II (888) 669-6682 BI-505 (Orphan Drug) BioInvent International Lund, Sweden second-line late-stage multiple myeloma Phase I www.bioinvent.com BIW-8962 Kyowa Hakko Kirin Pharma Princeton, NJ carfilzomib (Orphan Drug) Onyx Pharmaceuticals South San Francisco, CA Phase I/II (609) 919-1100 third-line multiple myeloma (Fast Track) (see also solid tumors) -------------------------------------------------multiple myeloma (combination therapy) application submitted (650) 266-0000 ------------------------------------------Phase I/II (650) 266-0000 CB3304 (noscapine) Cougar Biotechnology Raritan, NJ CC-115 (kinase inhibitor) Celgene Summit, NJ (see also lymphoma, solid tumors) Phase I (908) 673-9000 CC-122 Celgene Summit, NJ (see also lymphoma, solid tumors) Phase I (908) 673-9000 CC-223 (mTOR inhibitor) Celgene Summit, NJ (see also lung, lymphoma) Phase I (908) 673-9000 Medicines in Development Cancer 2012 Phase I/II www.cougarbiotechnology.com 63 Medicines in Development for Cancer Multiple Myeloma Product Name Sponsor CP-18770 (delanzomib) Cephalon Frazer, PA CX-4945 (CK2 inhibitor) Cylene Pharmaceuticals San Diego, CA daratumumab Genmab Princeton, NJ darinaparsin (ZIO-101) ZIOPHARM Oncology New York, NY (see also liver, lymphoma, solid tumors) Phase II (646) 214-0700 DFRF-4539A Genentech South San Francisco, CA refractory metastatic multiple myeloma Phase I (800) 626-3553 elotuzumab (BMS-901608) Bristol-Myers Squibb Princeton, NJ ENMD-2076 (Orphan Drug) EntreMed Rockville, MD relapsed or refractory multiple myeloma (see also ovarian, other) Phase I (240) 864-2600 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA second-line multiple myeloma (see also breast, colorectal, leukemia, liver, lung, pancreatic, prostate, skin, stomach) Phase I (781) 274-8200 GL-0817 Gliknik Baltimore, MD (see also head/neck) Phase II www.gliknik.com GSK2110183 (protein kinase B inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also leukemia) Phase I/II (888) 825-5249 GVAX® Myeloma cancer vaccine BioSante Pharmaceuticals Lincolnshire, IL ibrutinib (PCI-32765) Janssen Biotech Horsham, PA Pharmacyclics Sunnyvale, CA (see also leukemia, lymphoma) Phase II (800) 526-7736 (408) 774-0330 imetelstat Geron Menlo Park, CA second-line multiple myeloma (monotherapy) (see also breast, leukemia, lung) Phase II (650) 473-7700 indatuximab ravtansine (Orphan Drug) Biotest Dreieich, Germany relapsed or refractory multiple myeloma Phase I/II www.biotest.de 64 Indication Development Status Phase II (610) 344-0200 (see also solid tumors) Phase I (858) 875-5100 Phase I/II (609) 430-2481 Phase III (800) 332-2056 Phase II (847) 478-0500 Medicines in Development Cancer 2012 Medicines in Development for Cancer Multiple Myeloma Product Name Sponsor Indication Development Status INK128 (mTOR inhibitor) Intellikine La Jolla, CA (see also lymphoma, solid tumors) Phase I (858) 768-6500 IPH-2101 (anti-KIR mAb) Innate Pharma Marseille, France multiple myeloma (monotherapy) -------------------------------------------------multiple myeloma (combination therapy) Phase II www.innate-pharma.com ------------------------------------------Phase I/II www.innate-pharma.com KW-2478 Kyowa Hakko Kirin Pharma Princeton, NJ multiple myeloma (combination therapy) Phase I/II (609) 919-1100 LBH589 (panobinostat) Novartis Pharmaceuticals East Hanover, NJ (see also kidney, leukemia, prostate, solid tumors) Phase III (888) 669-6682 lorvotuzumab mertansine (IMGN901) ImmunoGen Waltham, MA (see also lung) Phase I (781) 895-0600 mapatumumab Human Genome Sciences Rockville, MD multiple myeloma (combination therapy) (see also liver, lung) Phase II (301) 309-8504 melphalan intravenous (captisol-enabled) (Orphan Drug) CyDex Pharmaceuticals Lenexa, KS milatuzumab Immunomedics Morris Plains, NJ recurrent multiple myeloma (see also leukemia, lymphoma) Phase I/II (973) 605-8200 MLN9708 (ixazomib) Millennium Pharmaceuticals Cambridge, MA newly diagnosed multiple myeloma (combination therapy), second-line multiple myeloma (see also lymphoma, solid tumors) Phase I/II (800) 390-5663 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ (see also breast, colorectal, head/ neck, kidney, leukemia, liver, lung, ovarian, other) Phase I/II (888) 842-2937 NPI-0052 (marizomib) Nereus Pharmaceuticals San Diego, CA (see also lymphoma, solid tumors) Phase I (858) 587-4090 obatoclax Cephalon Frazer, PA (see also leukemia, lung, lymphoma) Phase I completed (610) 344-0200 Medicines in Development Cancer 2012 Phase II www.ligand.com/cydex 65 Medicines in Development for Cancer Multiple Myeloma Product Name Sponsor Indication Development Status perifosine (Orphan Drug) AEterna Zentaris Basking Ridge, NJ recurrent multiple myeloma (combination therapy) (Fast Track) (see also brain, colorectal, kidney, leukemia, lung, lymphoma, sarcoma, solid tumors, stomach) Phase III (908) 626-5428 RG7444 (MFGR-1877S) Genentech South San Francisco, CA refractory metastatic multiple myeloma (see also solid tumors) Phase I (800) 626-3553 RG7598 (antibody drug conjugate) Genentech South San Francisco, CA samarium SM-153 lexidronam injection EUSA Pharma Langhorne, PA (see also breast, prostate, sarcoma, other) Phase I/II (800) 833-3533 SF1126 Semafore Pharmaceuticals Indianapolis, IN (see also leukemia, solid tumors) Phase I (317) 876-3075 siltuximab Janssen Biotech Horsham, PA (see also prostate, other) Phase II (800) 526-7736 SNS01-T (nano-encapsulated gene therapy) (Orphan Drug) Senesco Technologies Bridgewater, NJ second-line multiple myeloma Phase I/II (908) 864-4444 TH-302 Threshold Pharmaceuticals South San Francisco, CA (see also brain, leukemia, pancreatic, sarcoma) Phase I/II (650) 474-8200 TKI258 (dovitinib) Novartis Pharmaceuticals East Hanover, NJ (see also breast, kidney, prostate, skin, other) Phase II (888) 669-6682 trametinib GlaxoSmithKline Rsch. Triangle Park, NC multiple myeloma (see also leukemia, lung, lymphoma, pancreatic, skin) Phase I/II (888) 825-5249 Treanda® bendamustine Cephalon Frazer, PA second-line multiple myeloma (combination therapy) (see also leukemia, lymphoma) Phase I/II (610) 344-0200 Xgeva™ denosumab Amgen Thousand Oaks, CA (see also cancer-related, other) Phase II (800) 772-6436 Zolinza® vorinostat (Orphan Drug) Merck Whitehouse Station, NJ metastatic multiple myeloma (see also breast, leukemia, lung, lymphoma, other) Phase III (800) 672-6273 66 Phase I (800) 626-3553 Medicines in Development Cancer 2012 Medicines in Development for Cancer Ovarian Cancer Product Name Sponsor Indication Development Status Å6 Angstrom Pharmaceuticals Solana Beach, CA (see also other) Phase II (858) 314-2356 abagovomab (anti-idiotype mAb vaccine) (Orphan Drug) Menarini Florence, Italy Abraxane® albumin-bound paclitaxel Celgene Summit, NJ (see also bladder, breast, lung, pancreatic, skin) Phase II (908) 673-9000 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL (see also brain, breast, colorectal, lung, lymphoma, prostate, skin, other) Phase II (847) 937-6100 AE37 peptide vaccine Antigen Express Worcester, MA (see also breast) Phase I (508) 852-8783 AEZS-108 (Orphan Drug) AEterna Zentaris Basking Ridge, NJ (see also bladder, prostate, other) Phase II (908) 626-5428 Avastin® bevacizumab (Orphan Drug) Genentech South San Francisco, CA relapsed, platinum-sensitive ovarian cancer (see also brain, breast, colorectal, lung, other) -------------------------------------------------first-line metastatic ovarian cancer application submitted (800) 626-3553 Phase III www.menarini.com ------------------------------------------Phase III (800) 626-3553 BC-819 (gene therapy) (Orphan Drug) BioCancell Therapeutics Jerusalem, Israel late-stage ovarian cancer (see also bladder, pancreatic) Phase I/II www.biocancell.com belinostat Spectrum Pharmaceuticals Henderson, NV late-stage ovarian cancer (combination therapy) (see also colorectal, leukemia, liver, lung, lymphoma, other) Phase II completed (702) 835-6300 cabozantinib (XL184) Exelixis South San Francisco, CA (see also breast, kidney, lung, prostate, other) Phase II (650) 837-7000 catumaxomab Fresenius Biotech North America Waltham, MA (see also other) Phase II www.fresenius-biotech.com CVac™ MUC-1 cancer vaccine Prima BioMed Sydney, Australia Medicines in Development Cancer 2012 Phase II/III www.primabiomed.com.au 67 Medicines in Development for Cancer Ovarian Cancer Product Name Sponsor DCVax®-Ovarian dendritic cell-based vaccine Northwest Biotherapeutics Bethesda, MD DMUC-5754A Genentech South San Francisco, CA second-line ovarian cancer (see also other) Phase I (800) 626-3553 DPX-0907 Immunovaccine Halifax, Canada (see also breast, prostate) Phase I (902) 492-1819 DPX-survivac cancer vaccine Immunovaccine Halifax, Canada E7850 (irofulven) Eisai Woodcliff Lake, NJ (see also prostate, other) Phase II (888) 422-4743 EC20 (technetium Tc-99m etarfolatide) Endocyte West Lafayette, IN ovarian cancer (diagnosis) (see also lung) Phase III www.endocyte.com EC145 (vintafolide) Endocyte West Lafayette, IN Merck Whitehouse Station, NJ platinum-resistant ovarian cancer (see also lung) Phase III www.endocyte.com (800) 672-6372 EGEN-001 (Orphan Drug) EGEN Huntsville, AL (see also colorectal, other) Phase II (256) 512-0077 elesclomol Synta Pharmaceuticals Lexington, MA (see also leukemia, lung) Phase II (781) 274-8200 ENMD-2076 (Orphan Drug) EntreMed Rockville, MD platinum-resistant ovarian cancer (see also multiple myeloma, other) Phase II (240) 864-2600 etirinotecan pegol (NKTR-102) (Orphan Drug) Nektar Therapeutics San Francisco, CA platinum-resistant ovarian cancer (see also breast, colorectal, solid tumors) Phase II (855) 482-6587 FANG™ Vaccine autologous tumor cell vaccine Gradalis Carrollton, TX adjuvant ovarian cancer (see also colorectal, skin) Phase II (214) 442-8100 folate binding protein (E39) vaccine Galena Biopharma Lake Oswego, OR (see also breast, other) Phase I/II (855) 855-4253 iboctadekin GlaxoSmithKline Rsch. Triangle Park, NC (see also lymphoma) Phase I completed (888) 825-5249 68 Indication Development Status Phase I (240) 497-9024 Phase I (902) 492-1819 Medicines in Development Cancer 2012 Medicines in Development for Cancer Ovarian Cancer Product Name Sponsor Indication Development Status IMT-1012 immunotherapeutic vaccine Immunotope Doylestown, PA (see also breast) Phase I (215) 253-4180 iniparib (BSI-201) Sanofi US Bridgewater, NJ (see also breast, lung) Phase II (800) 981-2491 Karenitecin® cositecan BioNumerik Pharmaceuticals San Antonio, TX advanced ovarian cancer (see also lung, solid tumors) Phase III (210) 614-1701 KHK-2866 Kyowa Hakko Kirin Pharma Princeton, NJ ovarian cancer (combination therapy) (see also solid tumors) Phase I (609) 919-1100 MK-1775 (Wee1 inhibitor) Merck Whitehouse Station, NJ second-line ovarian cancer Phase II (800) 672-6372 MORAb-003 (farletuzumab) Eisai Woodcliff Lake, NJ platinum-sensitive ovarian cancer (see also lung) Phase III (888) 422-4743 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ first-line ovarian cancer (see also breast, colorectal, head/neck, kidney, leukemia, liver, lung, multiple myeloma, other) Phase II (888) 842-2937 OGX-427 OncoGenex Pharmaceuticals Bothell, WA (see also breast, lung) Phase I (425) 686-1500 olaratumab (LY3012207) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ (see also brain) Phase II (800) 545-5979 ombrabulin (AVE8062) Sanofi US Bridgewater, NJ second-line ovarian cancer (see also lung, sarcoma) Phase II (800) 981-2491 Opaxio™ paclitaxel poliglumex Cell Therapeutics Seattle, WA (see also brain, lung, stomach, other) Phase III (800) 215-2355 oregovomab (Orphan Drug) Quest PharmaTech Edmonton, Canada OSI-906 (IGF-1R/1R tyrosinase kinase inhibitor) OSI Pharmaceuticals Farmingdale, NY OVax® autologous cell vaccine (Orphan Drug) AVAX Technologies Philadelphia, PA Medicines in Development Cancer 2012 Phase I/II (780) 448-1400 (see also lung, other) Phase II (631) 962-0600 Phase I/II (215) 241-9760 69 Medicines in Development for Cancer Ovarian Cancer Product Name Sponsor Indication Development Status phenoxodiol Marshall Edwards San Diego, CA second-line late-stage ovarian cancer (Fast Track) (see also prostate, other) Phase III (858) 792-6300 picoplatin Ponaird Pharmaceuticals Seattle, WA (see also colorectal, lung, prostate) Phase II (206) 281-7001 Quinamed® amonafide Cephalon Frazer, PA (see also breast, prostate) Phase II (610) 344-0200 Reolysin® reovirus Oncolytics Biotech Calgary, Canada ovarian cancer (combination therapy) (see also brain, colorectal, head/neck, lung, pancreatic, sarcoma, skin, solid tumors) -------------------------------------------------ovarian cancer (monotherapy) Phase II (403) 670-7377 ------------------------------------------Phase I (403) 670-7377 RG7458 Genentech South San Francisco, CA RG7599 (antibody drug conjugate) Genentech South San Francisco, CA (see also lung) Phase I (800) 626-3553 RG7600 (antibody drug conjugate) Genentech South San Francisco, CA platinum-resistant ovarian cancer (see also pancreatic) Phase I (800) 626-3553 rigosertib Onconova Therapeutics Newtown, PA (see also leukemia, lymphoma, pancreatic) Phase II (267) 759-3680 rucaparib Clovis Oncology Boulder, CO (see also breast) Phase II (303) 625-5000 sagopilone Bayer HealthCare Pharmaceuticals Wayne, NJ (see also breast, prostate) Phase II completed (888) 842-2937 SAR256212 (MM-121) (anti-ErbB3 mAb) Merrimack Pharmaceuticals Cambridge, MA Sanofi US Bridgewater, NJ (see also breast, lung) Phase I (800) 981-2491 SG2000 Spirogen London, United Kingdom squalamine (Orphan Drug) OHR Pharmaceutical New York, NY resistant ovarian cancer Phase II (212) 682-8452 Telcyta™ canfosfamide Telik Palo Alto, CA (see also lung, lymphoma) Phase III completed (650) 845-7700 70 Phase I (800) 626-3553 Phase II www.spirogen.com Medicines in Development Cancer 2012 Medicines in Development for Cancer Ovarian Cancer Product Name Sponsor Indication Development Status tigatuzumab (anti-DR5 antibody) Daiichi Sankyo Parsippany, NJ (see also breast, colorectal, liver, lymphoma, pancreatic) Phase II (973) 944-2600 topotecan liposomes injection Talon Therapeutics San Mateo, CA (see also lung) Phase I (650) 588-6404 trabectedin (Orphan Drug) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ second-line ovarian cancer (see also breast, prostate, sarcoma) Phase III (800) 817-5286 TRC 105 (ENG protein inhibitor) TRACON Pharmaceuticals San Diego, CA (see also breast, prostate, other) Phase II (858) 550-0780 trebananib (AMG386) Amgen Thousand Oaks, CA (see also breast, colorectal, kidney, liver, stomach, other) Phase III (800) 772-6436 Vargatef™ intedanib Boehringer Ingelheim Pharmaceuticals Ridgefield, CT first-line late-stage ovarian cancer (combination therapy) (see also lung) Phase III (800) 243-0127 vosaroxin Sunesis Pharmaceuticals South San Francisco, CA (see also leukemia) Phase II (650) 266-3739 Votrient™ pazopanib GlaxoSmithKline Rsch. Triangle Park, NC (see also kidney, other) Phase III (888) 825-5249 Zybrestat™ fosbretabulin (Orphan Drug) OXiGENE South San Francisco, CA (see also lung) Phase II (650) 635-7000 Pancreatic Cancer Product Name Sponsor Indication Development Status Abraxane® albumin-bound paclitaxel (Orphan Drug) Celgene Summit, NJ (see also bladder, breast, lung, ovarian, skin) Phase III (908) 673-9000 Actimid® pomalidomide Celgene Summit, NJ (see also lung, lymphoma, multiple myeloma) Phase I/II (908) 673-9000 Medicines in Development Cancer 2012 71 Medicines in Development for Cancer Pancreatic Cancer Product Name Sponsor anti-MUC1 mAb Quest PharmaTech Edmonton, Canada anti-PSCA mAb Agensys Santa Monica, CA Astellas Pharma US Deerfield, IL metastatic pancreatic cancer (combination therapy) Phase II (800) 695-4321 apricoxib (TG01) Tragara Pharmaceuticals San Diego, CA pancreatic (combination therapy) (see also lung) Phase II (858) 350-6900 Archexin® RX-0201 (Orphan Drug) Rexahn Pharmaceuticals Rockville, MD metastatic pancreatic cancer (combination therapy) Phase II (240) 268-5300 ASG-5ME Agensys Santa Monica, CA Seattle Genetics Bothell, WA metastatic pancreatic cancer (see also prostate) Phase I (800) 695-4321 (425) 527-4000 bavituximab Peregrine Pharmaceuticals Tustin, CA first-line pancreatic cancer (see also liver, lung) Phase II (715) 508-6000 BAY 86-9766 (MEK inhibitor) Ardea Biosciences San Diego, CA Bayer HealthCare Pharmaceuticals Wayne, NJ first-line pancreatic cancer (combination therapy) (see also liver) Phase I/II (888) 842-2937 BC-819 (gene therapy) (Orphan Drug) BioCancell Therapeutics Jerusalem, Israel first-line late-stage pancreatic cancer (combination therapy) (Fast Track) (see also bladder, ovarian) Phase II www.biocancell.com Chk1 inhibitor (LY2603618) Eli Lilly Indianapolis, IN (see also lung) Phase II (800) 545-5979 CO-101 (lipid drug conjugate of gemcitabine) (Orphan Drug) Clovis Oncology Boulder, CO first-line metastatic pancreatic cancer, second-line metastatic pancreatic cancer Phase II (303) 625-5000 CO-101 companion diagnostic (hENT1 IHC assay) Clovis Oncology Boulder, CO Ventana Medical Systems Tucson, AZ pancreatic cancer (diagnosis) in clinical trials (303) 625-5000 CPI-613 (Orphan Drug) Cornerstone Pharmaceuticals Cranbury, NJ combination therapy (see also other) Phase I/II (609) 409-7050 72 Indication Development Status Phase I/II (780) 448-1400 Medicines in Development Cancer 2012 Medicines in Development for Cancer Pancreatic Cancer Product Name Sponsor Indication Development Status CRS-207 (cancer vaccine) Aduro BioTech Berkeley, CA metastatic pancreatic cancer (combination therapy) Phase II (510) 848-4400 dalotuzumab (MK-0646) Merck Whitehouse Station, NJ (see also breast, lung, other) Phase I/II (800) 672-6372 encapsulated cell therapy (macrobeads) Rogosin Institute New York, NY refractory metastatic pancreatic cancer (see also colorectal, prostate) Phase II (212) 746-1566 FG-3019 (connective tissue growth factor) FibroGen San Francisco, CA ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA (see also breast, colorectal, leukemia, liver, lung, multiple myeloma, prostate, skin, stomach) Phase II (781) 274-8200 ganitumab (AMG 479) Amgen Thousand Oaks, CA first-line metastatic pancreatic cancer (combination therapy) (see also breast, colorectal, lung, sarcoma) Phase III (800) 772-6436 GI-4000 GlobeImmune Louisville, CO (see also colorectal, lung) Phase II (303) 625-2700 glufosfamide (Orphan Drug) Eleison Pharmaceuticals Princeton, NJ pancreatic cancer (Fast Track) Phase III completed (215) 554-3530 GS-6624 (monoclonal antibody) Gilead Sciences Foster City, CA (see also colorectal) Phase II (800) 445-3235 GV1001 (hTERT RNA vaccine) KAEL-GemVax Seoul, South Korea Phase I www.kaelgemvax.com GVAX® Pancreatic cancer vaccine (Orphan Drug) BioSante Pharmaceuticals Lincolnshire, IL Aduro BioTech Berkeley, CA Phase II (847) 478-0500 (510) 848-4400 HyperAcute® Pancreas algenpantucel-L (Orphan Drug) NewLink Genetics Ames, IA Phase III (515) 296-5555 IMP321 Immutep Châtenay-Malabry, France Phase I www.immutep.org INNO-206 (Orphan Drug) CytRx Los Angeles, CA Medicines in Development Cancer 2012 Phase II (415) 978-1200 pancreatic ductal adenocarcinoma (see also sarcoma, solid tumors) Phase II (310) 826-5648 73 Medicines in Development for Cancer Pancreatic Cancer Product Name Sponsor Indication Development Status Istodax® romidepsin Celgene Summit, NJ (see also kidney, prostate, other) Phase I/II (908) 673-9000 Jakafi™ ruxolitinib Incyte Wilmington, DE (see also other) Phase II (855) 446-2983 KD032 (ras/mTOR inhibitor) Kadmon Pharmaceuticals Warrendale, PA (see also lung) Phase I/II completed (724) 778-6100 LDE225 (erismodegib) Novartis Pharmaceuticals East Hanover, NJ neoadjuvant pancreatic cancer (see also leukemia, solid tumors, skin) Phase I/II (888) 669-6682 LE-DT (liposomal docetaxel) Insys Therapeutics Phoenix, AZ first-line pancreatic cancer Phase II (602) 910-2617 M402 (low molecular weight heparin) Momenta Pharmaceuticals Cambridge, MA metastatic pancreatic cancer Phase I/II (617) 491-9700 masitinib AB Science USA Short Hills, NJ (see also stomach) Phase III (973) 218-2437 MM-398 (nanotherapeutic) (Orphan Drug) Merrimack Pharmaceuticals Cambridge, MA metastatic pancreatic cancer Phase II (617) 441-1000 naptumomab estafenatox Active Biotech Lund, Sweden (see also kidney, lung) Phase I completed www.activebiotech.com NPC-1C (ensituximab) (Orphan Drug) Neogenix Oncology Rockville, MD late-stage, metastatic pancreatic cancer (see also colorectal) Phase I (301) 917-6893 paclitaxel polymeric micelle formulation Samyang Biopharmaceuticals Seoul, South Korea late-stage pancreatic cancer Phase II www.samyangpharm.com PancAtak™ gene therapy Advantagene Auburndale, MA PCI-27483 (factor VIIa inhibitor) Pharmacyclics Sunnyvale, CA PEGPH20 (pegylated recombinant human hyaluronidase) Halozyme Therapeutics San Diego, CA 74 Phase I (617) 916-5445 metastatic pancreatic cancer (combination therapy) Phase II (408) 774-0330 Phase I/II (858) 794-8889 Medicines in Development Cancer 2012 Medicines in Development for Cancer Pancreatic Cancer Product Name Sponsor Indication Development Status PHY906 PhytoCeutica New Haven, CT (see also colorectal, liver, cancer-related) Phase I/II (203) 777-3462 polyclonal antibody stimulator (Orphan Drug) Cancer Advances Durham, NC (see also colorectal, stomach) Phase III (919) 361-2162 Reolysin® reovirus Oncolytics Biotech Calgary, Canada pancreatic cancer (combination therapy) (see also brain, colorectal, head/ neck, lung, ovarian, sarcoma, skin, solid tumors) Phase II (403) 670-7377 Rexin-G® (Orphan Drug) Epeius Biotechnologies San Marino, CA metastatic pancreatic cancer (Fast Track) (see also breast, sarcoma) Phase I/II (626) 441-6695 RG7600 (antibody drug conjugate) Genentech South San Francisco, CA platinum-resistant pancreatic cancer (see also ovarian) Phase I (800) 626-3553 rigosertib Onconova Therapeutics Newtown, PA (see also leukemia, lymphoma, ovarian) Phase II/III (267) 759-3680 RP101 RESprotect Dresden, Germany SecreFlo™ synthetic human secretin Repligen Waltham, MA pancreatic cancer (diagnosis) Phase 0 (781) 250-0111 SPRYCEL® dasatinib Bristol-Myers Squibb Princeton, NJ (see also brain, breast, prostate, other) in clinical trials (800) 332-2056 TH-302 Threshold Pharmaceuticals South San Francisco, CA (see also brain, leukemia, multiple myeloma, sarcoma) Phase II (650) 474-8200 tigatuzumab (anti-DR5 antibody) Daiichi Sankyo Parsippany, NJ (see also breast, colorectal, liver, lymphoma, ovarian) Phase II completed (973) 944-2600 tivantinib (ARQ 197) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ (see also colorectal, kidney, liver, lung, sarcoma, other) Phase I (781) 994-0300 (973) 944-2600 trametinib GlaxoSmithKline Rsch. Triangle Park, NC first-line pancreatic cancer (see also leukemia, lung, lymphoma, multiple myeloma, skin) Phase II (888) 825-5249 uridine triacetate (PN401) Wellstat Therapeutics Gaithersburg, MD (see also stomach) Phase III (240) 631-2500 Medicines in Development Cancer 2012 Phase II/III www.resprotect.de 75 Medicines in Development for Cancer Pancreatic Cancer Product Name Sponsor Virulizin® Lorus Therapeutics Toronto, Canada Y-90 clivatuzumab (Orphan Drug) Immunomedics Morris Plains, NJ Indication Development Status Phase III (416) 798-1200 first-line pancreatic cancer (Fast Track) Phase I/II (973) 605-8200 Prostate Cancer Product Name Sponsor Indication Development Status 99mTc-MIP-1405 Molecular Insight Pharmaceuticals Cambridge, MA prostate cancer (diagnosis) Phase I (617) 492-5554 ABI-008 (nab®-docetaxel) Celgene Summit, NJ first-line hormone-refractory prostate cancer Phase I/II (908) 673-9000 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL (see also brain, breast, colorectal, lung, lymphoma, ovarian, skin, other) Phase I (847) 937-6100 AEZS-108 AEterna Zentaris Basking Ridge, NJ (see also bladder, ovarian, other) Phase II (908) 626-5428 anti-OX40 mAb AgonOx Portland, OR AP1903 Bellicum Pharmaceuticals Houston, TX Apatone® ascorbic acid/menadione IC-MedTech San Diego, CA Phase I/II (619) 749-6500 APC-100 Adamis Pharmaceuticals San Diego, CA Phase I/II www.adamispharmaceuticals. com ARC-100 Archer Biosciences New York, NY hormone-refractory prostate cancer (see also brain, breast, skin) Phase II (646) 747-9090 ARN-509 Aragon Pharmaceuticals San Diego, CA hormone-refractory prostate cancer Phase I/II (858) 369-7600 76 Phase I (800) 979-7202 (see also cancer-related) Phase I/II (713) 341-6472 Medicines in Development Cancer 2012 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor Indication Development Status ASG-5ME Agensys Santa Monica, CA Seattle Genetics Bothell, WA castration-resistant prostate cancer (see also pancreatic) Phase I (800) 695-4321 (425) 527-4000 AT-101 (oral pan Bcl-2 inhibitor) Ascenta Therapeutics Malvern, PA hormone-refractory prostate cancer (combination therapy) (see also brain, leukemia, lung, lymphoma, stomach) -------------------------------------------------hormone-sensitive prostate cancer Phase II (610) 408-0301 ------------------------------------------Phase I (610) 408-0301 AZD3514 (androgen receptor down-regulator) AstraZeneca Wilmington, DE bafetinib CytRx Los Angeles, CA BPX-101 (dendritic cell vaccine) Bellicum Pharmaceuticals Houston, TX cabozantinib (XL184) Exelixis South San Francisco, CA castration-resistant prostate cancer (see also breast, kidney, lung, ovarian, other) Phase III (650) 837-7000 CBLC102 (mepacrine) Cleveland BioLabs Buffalo, NY Incuron Moscow, Russia hormone-refractory prostate cancer Phase II completed (716) 849-6810 CD1089 (seocalcitol) Cougar Biotechnology Raritan, NJ cilengitide EMD Serono Rockland, MA (see also brain) Phase III (800) 283-8088 custirsen (OGX-011/TV-1011) OncoGenex Pharmaceuticals Bothell, WA Teva Pharmaceuticals Tikva, Israel first-line prostate cancer (combination therapy), second-line hormonerefractory prostate cancer (combination therapy) (Fast Track) (see also lung) Phase III (425) 686-1500 CYT-500 EUSA Pharma Langhorne, PA DPX-0907 Immunovaccine Halifax, Canada Medicines in Development Cancer 2012 Phase I (800) 236-9933 second-line metastatic hormonerefractory prostate cancer (see also brain, leukemia) Phase II (310) 826-5648 Phase I/II (713) 341-6472 Phase I www.cougarbiotechnology.com Phase I (800) 833-3533 (see also breast, ovarian) Phase I (902) 492-1819 77 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor Indication Development Status DSTP-3086S Genentech South San Francisco, CA metastatic hormone-refractory prostate cancer Phase I (800) 626-3553 E7850 (irofulven) Eisai Woodcliff Lake, NJ hormone-refractory prostate cancer (see also ovarian, other) Phase II (888) 422-4743 EMD-525797 (anti-integrin mAb) EMD Serono Rockland, MA metastatic castration-resistant prostate cancer Phase II/III (800) 283-8088 emepepimut-S EMD Serono Rockland, MA Oncothyreon Seattle, WA newly-diagnosed prostate cancer (see also lung) Phase II (800) 283-8088 encapsulated cell therapy (macrobeads) Rogosin Institute New York, NY refractory metastatic prostate cancer (see also colorectal, pancreatic) Phase II (212) 746-1566 enzalutamide (MDV3100) Astellas Pharma Tokyo, Japan Medivation San Francisco, CA hormone-refractory prostate cancer (Fast Track) Phase III (415) 543-3470 EPO-806 (patupilone) Novartis Pharmaceuticals East Hanover, NJ (see also brain) Phase II (888) 669-6682 EZN-4176 (antisense oligonucleotide) Enzon Pharmaceuticals Piscataway, NJ Firmagon® degarelix Ferring Pharmaceuticals Parsippany, NJ 3-month formulation ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA second-line hormone-refractory prostate cancer (see also breast, colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, skin, stomach) Phase II (781) 274-8200 Gleevec® imatinib Novartis Pharmaceuticals East Hanover, NJ hormone-refractory prostate cancer (see also lung, skin, other) Phase II (888) 669-6682 GRNVAC1 (dendritic cell vaccine) Argos Therapeutics Durham, NC Geron Menlo Park, CA (see also leukemia) Phase I/II (650) 473-7700 78 Phase I (973) 980-4500 -------------------------------------------------neoadjuvant therapy Phase III (973) 796-1600 ------------------------------------------Phase III (973) 796-1600 Medicines in Development Cancer 2012 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor Indication Development Status GTx-758 (selective estrogen receptor alpha agonist) GTx Memphis, TN first-line advanced prostate cancer, second-line advanced prostate cancer Phase II (901) 523-9700 GVAX® Prostate cancer vaccine BioSante Pharmaceuticals Lincolnshire, IL Aduro BioTech Berkeley, CA (Fast Track) Phase III (847) 478-0500 (510) 848-4400 Halaven® eribulin Eisai Woodcliff Lake, NJ (see also lung, sarcoma) Phase II (888) 422-4743 HE3235 Harbor Therapeutics San Diego, CA hormone-refractory prostate cancer Phase I/II (858) 587-9333 intetumumab Janssen Biotech Horsham, PA (see also skin) Phase II completed (800) 526-7736 IRX4204 Io Therapeutics Santa Ana, CA ISIS-EIF4ERx Isis Pharmaceuticals Carlsbad, CA prostate cancer (combination therapy) (see also lung) Phase II (800) 679-4747 Istodax® romidepsin Celgene Summit, NJ (see also kidney, pancreatic, other) Phase II (908) 673-9000 J 591 Lu-177 (anti-PMSA mAb) BZL Biologics New York, NY metastatic prostate cancer, non-metastatic prostate cancer Phase II (212) 315-5575 JNJ-26854165 (Hdm2 inhibitor) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ (see also lung, solid tumors) Phase I (800) 817-5286 KX2-391 Kinex Pharmaceuticals Buffalo, NY (see also leukemia) Phase II (716) 898-8626 LBH589 (panobinostat) Novartis Pharmaceuticals East Hanover, NJ (see also kidney, leukemia, multiple myeloma, solid tumors) Phase II (888) 669-6682 LFA102 (anti-prolactin receptor antibody) Novartis Pharmaceuticals East Hanover, NJ XOMA Berkeley, CA (see also breast) Phase I (888) 669-6682 LOR-2040 Lorus Therapeutics Toronto, Canada metastatic prostate cancer (see also breast, colorectal, kidney, leukemia) Phase II (416) 798-1200 Medicines in Development Cancer 2012 Phase II www.io-therapeutics.com 79 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor MER-104 (GnRH antagonist) Merrion Pharmaceuticals Wilmington, DE Phase I (910) 799-1847 MVA-BN® PRO antigen cancer vaccine BN ImmunoTherapeutics Mountain View, CA Phase I/II (650) 681-4660 NeuVax™ cancer vaccine E75 Galena Biopharma Lake Oswego, OR (see also breast) Phase I/II (855) 855-4253 nimotuzumab YM Biosciences USA Lehigh Valley, PA (see also brain, breast) Phase II (610) 560-0600 NX-1207 Nymox Pharmaceutical Quebec, Canada ODM-201 (androgen receptor antagonist) Endo Pharmaceuticals Chadds Ford, PA Orion Espoo, Finland oncolytic virus CZ BioMed Tampa, FL Phase I (813) 600-4088 Onyvax-105 anti-idiotype cancer vaccine 105AD7 VaxOnco Seoul, South Korea Phase II www.vaxonco.com Onyvax-P (prostate cancer vaccine) VaxOnco Seoul, South Korea Phase II ozarelix Spectrum Pharmaceuticals Henderson, NV hormone-dependent prostate cancer Phase II (702) 835-6300 PEG arginine deiminase (ADI-PEG 20) Polaris Pharmaceuticals San Diego, CA prostate cancer (combination therapy) (see also liver, skin, other) Phase I (858) 452-6688 phenoxodiol Marshall Edwards San Diego, CA prostate cancer (Fast Track) (see also ovarian, other) Phase II completed (858) 792-6300 picoplatin Ponaird Pharmaceuticals Seattle, WA (see also colorectal, lung, prostate) Phase II (206) 281-7001 ProstAtak™ gene therapy Advantagene Auburndale, MA adjuvant prostate cancer (Fast Track) Phase III (617) 916-5445 80 Indication Development Status Phase II (800) 936-9669 castration-resistant prostate cancer Phase II (800) 462-3636 Medicines in Development Cancer 2012 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor prostate cancer vaccine (anti-GnRH) Novartis Vaccines & Diagnostics Cambridge, MA Pepscan Therapeutics Lelystad, Netherlands Prostvac™ rilimogene galvacirepvec BM ImmunoTherapeutics Mountain View, CA castration-resistant prostate cancer (Fast Track) Phase III (650) 681-4660 Provenge® sipuleucel-T Dendreon Seattle, WA recurrent early-stage prostate cancer Phase III (877) 256-4545 ------------------------------------------Phase II (877) 256-4545 PRX-302 Sophiris Bio La Jolla, CA Phase II (858) 777-1760 PSMA ADC (anti-drug conjugate) Progenics Pharmaceuticals Tarrytown, NY Phase I (914) 789-2800 PSMA protein vaccine (recombinant soluble) Progenics Pharmaceuticals Tarrytown, NY Phase I (914) 789-2800 PSMA VRP therapeutic vaccine Progenics Pharmaceuticals Tarrytown, NY Phase I (914) 789-2800 PX-866 Oncothyreon Seattle, WA hormone-refractory prostate cancer (see also brain, head/neck, lung) Phase II (206) 801-2100 Quinamed® amonafide Cephalon Frazer, PA (see also breast, ovarian) Phase II (610) 344-0200 REIC gene therapy Momotaro-Gene Okayama, Japan ridaforolimus ARIAD Pharmaceuticals Cambridge, MA Merck Whitehouse Station, NJ (see also breast, kidney, lung, sarcoma, other) Phase II (800) 672-6372 sagopilone Bayer HealthCare Pharmaceuticals Wayne, NJ (see also breast, ovarian) Phase II completed (888) 842-2937 samarium SM-153 lexidronam injection EUSA Pharma Langhorne, PA (see also breast, multiple myeloma, sarcoma, other) Phase II (800) 833-3533 siltuximab Janssen Biotech Horsham, PA hormone-refractory prostate cancer (see also multiple myeloma, other) Phase I (800) 526-7736 Medicines in Development Cancer 2012 Indication Development Status Phase I/II (617) 871-7000 -------------------------------------------------neoadjuvant early-stage prostate cancer Phase I www.mt-gene.com 81 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor Indication Development Status SPRYCEL® dasatinib Bristol-Myers Squibb Princeton, NJ (see also brain, breast, pancreatic, other) in clinical trials (800) 332-2056 TAK-448 (KISS1R protein agonist) Millennium Pharmaceuticals Cambridge, MA TAK-700 (orteronel) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 first-line metastatic prostate cancer (combination therapy), second-line metastatic prostate cancer (combination therapy) -------------------------------------------------prostate cancer Phase III (800) 390-5663 metastatic prostate cancer Phase III www.activebiotech.com ------------------------------------------Phase I www.activebiotech.com ------------------------------------------Phase II (800) 390-5663 tasquinimod (TASQ) Active Biotech Lund, Sweden TeloB-Vax telomerase cancer vaccine Adamis Pharmaceuticals San Diego, CA tesetaxel Genta Berkeley Heights, NJ (see also bladder, breast, skin, stomach) Phase II (908) 286-9800 tigapotide Kotinos Pharmaceuticals New York, NY hormone-refractory prostate cancer Phase II (212) 935-3000 TKI258 (dovitinib) Novartis Pharmaceuticals East Hanover, NJ (see also breast, kidney, multiple myeloma, skin, other) Phase II (888) 669-6682 TNFerade™ golnerminogene pradenovec GenVec Gaithersburg, MD (see also head/neck, skin, stomach) Phase I (877) 943-6832 TOK-001 Tokai Pharmaceuticals Cambridge, MA castration-resistant prostate cancer Phase I (617) 225-4305 trabectedin Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ (see also breast, ovarian, sarcoma) Phase II (800) 817-5286 TRC 105 (ENG protein inhibitor) TRACON Pharmaceuticals San Diego, CA (see also breast, ovarian, other) Phase I/II (858) 550-0780 82 -------------------------------------------------second-line metastatic prostate cancer Phase I www.adamispharmaceuticals. com Medicines in Development Cancer 2012 Medicines in Development for Cancer Prostate Cancer Product Name Sponsor Indication Development Status Trofex™ iofolastat I-124 Molecular Insight Pharmaceuticals Cambridge, MA prostate cancer (diagnosis) Phase I (617) 491-5554 TroVax® tumor-associated antigen vaccine Oxford BioMedica Oxford, United Kingdom hormone-refractory prostate cancer (combination therapy) Phase II www.oxfordbiomedica.co.uk VT-464 Viamet Pharmaceuticals Morrisville, NC YERVOY® ipilimumab Bristol-Myers Squibb Princeton, NJ prostate cancer (post-hormonal therapy), prostate cancer (post-chemotherapy) (see also lung, skin) in clinical trials (800) 332-2056 Zaltrap™ aflibercept Regeneron Pharmaceuticals Tarrytown, NY Sanofi US Bridgewater, NJ first-line androgen-independent prostate cancer (see also colorectal) Phase III (914) 345-7400 (800) 981-2491 Zytiga® abiraterone Janssen Biotech Horsham, PA first-line metastatic prostate cancer (see also breast) -------------------------------------------------neoadjuvant prostate cancer Phase III (800) 526-7736 ------------------------------------------Phase II (800) 526-7736 Product Name Sponsor Indication Development Status 8H9 I-131 mAb United Therapeutics Silver Spring, MD soft tissue sarcoma (see also brain, other) Phase I (301) 608-9292 abexinostat (HDAC inhibitor) Pharmacyclics Sunnyvale, CA sarcoma (see also lymphoma) Phase I/II (408) 774-0330 brivanib (VEGFR/FGFR kinase inhibitor) Bristol-Myers Squibb Princeton, NJ (see also colorectal, liver) Phase II (800) 332-2056 cancer vaccine MabVax Therapeutics San Diego, CA (see also breast) Phase II (858) 259-9405 ganitumab (AMG 479) Amgen Thousand Oaks, CA (see also breast, colorectal, lung, pancreatic) Phase II (800) 772-6436 Halaven® eribulin Eisai Woodcliff Lake, NJ (see also lung, prostate) Phase III (888) 422-4743 Phase I/II (919) 467-8539 Sarcoma Medicines in Development Cancer 2012 83 Medicines in Development for Cancer Sarcoma Product Name Sponsor Indication Development Status INNO-206 (Orphan Drug) CytRx Los Angeles, CA soft tissue sarcoma (see also pancreatic, solid tumors) Phase II (310) 826-5648 Junovan™ mifamurtide (Orphan Drug) Millennium Pharmaceuticals Cambridge, MA osteosarcoma Phase III (800) 390-5663 ombrabulin (AVE8062) Sanofi US Bridgewater, NJ (see also lung, ovarian) Phase III (800) 981-2491 palifosfamide (ZIO-201) (Orphan Drug) ZIOPHARM Oncology New York, NY first-line soft tissue sarcoma (combination therapy) (see also lung, solid tumors) -------------------------------------------------second-line soft tissue sarcoma (combination therapy) -------------------------------------------------soft tissue sarcoma (monotherapy) Phase III (646) 214-0700 perifosine AEterna Zentaris Basking Ridge, NJ (see also brain, colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, solid tumors, stomach) Phase II (908) 626-5428 PM-00104 PharmaMar Madrid, Spain Ewing’s sarcoma (see also cervical, other) Phase II www.pharmamar.com Reolysin® reovirus Oncolytics Biotech Calgary, Canada (see also brain, colorectal, head/ neck, lung, ovarian, pancreatic, skin, solid tumors) Phase II (403) 670-7377 Rexin-G® (Orphan Drug) Epeius Biotechnologies San Marino, CA osteosarcoma (see also breast, pancreatic) -------------------------------------------------soft tissue sarcoma Phase II (626) 441-6695 ------------------------------------------Phase I/II (626) 441-6695 ridaforolimus (Orphan Drug) ARIAD Pharmaceuticals Cambridge, MA Merck Whitehouse Station, NJ metastatic sarcoma (Fast Track) (see also breast, kidney, lung, prostate, other) -------------------------------------------------sarcoma application submitted (800) 672-6372 (626) 441-6695 ------------------------------------------Phase II (800) 672-6372 (626) 441-6695 robatumumab Merck Whitehouse Station, NJ osteosarcoma, sarcoma (see also colorectal, solid tumors) Phase II (800) 672-6372 84 ------------------------------------------Phase II (646) 214-0700 ------------------------------------------Phase I/II (646) 214-0700 Medicines in Development Cancer 2012 Medicines in Development for Cancer Sarcoma Product Name Sponsor Indication Development Status samarium SM-153 lexidronam injection EUSA Pharma Langhorne, PA osteosarcoma (see also breast, multiple myeloma, prostate, other) Phase I/II (800) 833-3533 saridegib (Orphan Drug) Infinity Pharmaceuticals Cambridge, MA chondrosarcoma (inoperable/unresectable) Phase II (617) 453-1000 TH-302 (Orphan Drug) Threshold Pharmaceuticals South San Francisco, CA soft tissue sarcoma (see also brain, leukemia, multiple myeloma, pancreatic) Phase III (650) 474-8200 tivantinib (ARQ 197) (Orphan Drug) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ soft tissue sarcoma (see also colorectal, kidney, liver, lung, pancreatic, other) Phase II (781) 994-0300 (973) 944-2600 trabectedin (Orphan Drug) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ soft tissue sarcoma (see also breast, ovarian, prostate) -------------------------------------------------soft tissue sarcoma (adolescents and children) Phase III (800) 817-5286 ------------------------------------------Phase II (800) 817-5286 Product Name Sponsor Indication Development Status Abraxane® albumin-bound paclitaxel (Orphan Drug) Celgene Summit, NJ malignant melanoma (see also bladder, breast, lung, ovarian, pancreatic) Phase III (908) 673-9000 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL malignant melanoma (see also brain, breast, colorectal, lung, lymphoma, ovarian, prostate, other) Phase II (847) 937-6100 Ad-IL-12 DNA therapeutic (INXN-2001) ZIOPHARM Oncology New York, NY malignant melanoma Phase I (646) 214-0700 Allovectin® velimogene aliplasmid (Orphan Drug) Vical San Diego, CA first-line malignant melanoma Phase III (858) 646-1100 Skin Cancer Medicines in Development Cancer 2012 85 Medicines in Development for Cancer Skin Cancer Product Name Sponsor Indication Development Status ALT-801 Altor BioScience Miramar, FL malignant melanoma (see also other) Phase I/II (954) 443-8600 anti-PD1 (BMS-936558) Bristol-Myers Squibb Princeton, NJ melanoma (see also kidney, lung) Phase II (800) 332-2056 APN301 (ch14.18 mAb/interleukin-2 fusion protein) Apeiron Biologics Vienna, Austria malignant melanoma (see also brain) Phase II www.apeiron-biologics.com ARC-100 Archer Biosciences New York, NY malignant melanoma (combination therapy) (see also brain, breast, prostate) Phase II (646) 747-9090 ARRY-162 (MEK inhibitor) Array BioPharma Boulder, CO malignant melanoma (BRAFV600E or NRAS mutations) (see also solid tumors) Phase II (877) 633-2436 astuprotimut-R (MAGE-A3 antigen-specific cancer immunotherapeutic) GlaxoSmithKline Rsch. Triangle Park, NC malignant melanoma (see also lung) -------------------------------------------------inoperable/unresectable malignant melanoma Phase III (888) 825-5249 ------------------------------------------Phase II (888) 825-5249 autologous stem cell therapy California Stem Cells Irvine, CA malignant melanoma Phase II (949) 534-9149 c31510 Cytotech Natick, MA basal cell cancer, squamous call cancer Phase II (615) 515-5438 Cavatak™ coxsackievirus A21 (Orphan Drug) Viralytics Pymble, Australia malignant melanoma Phase II www.viralytics.com CB-10-01 cancer vaccine Cosmo Pharmaceuticals Lainate, Italy malignant melanoma Phase II www.cosmopharmaceuticals. com CDX-011 (glembatumumab vedotin) Celldex Therapeutics Needham, MA malignant melanoma (see also breast) Phase II (781) 433-0771 CYT107 (interleukin-7) Cytheris Rockville, MD malignant melanoma (see also kidney) Phase I (301) 231-0451 DC-IL-12 DNA therapeutic (INXN-3001) ZIOPHARM Oncology New York, NY malignant melanoma Phase I (646) 214-0700 DEDN-6526A Genentech South San Francisco, CA malignant melanoma Phase I (800) 626-3553 86 Medicines in Development Cancer 2012 Medicines in Development for Cancer Skin Cancer Product Name Sponsor Indication Development Status dendritic cancer cell vaccine EMD Millipore Billerica, MA malignant melanoma Phase I (781) 533-6000 E7050 Eisai Woodcliff Lake, NJ late-stage malignant melanoma (see also brain, head/neck, liver, solid tumors, stomach) Phase I/II (888) 422-4743 E7080 (lenvatinib) Eisai Woodcliff Lake, NJ melanoma (see also brain, other) Phase II (888) 422-4743 ecromeximab Life Science Pharmaceuticals Darien, CT malignant melanoma (combination therapy) Phase II (203) 656-2500 Erivedge™ vismodegib Genentech South San Francisco, CA early-stage basal cell cancer (resectable) Phase II (800) 626-3553 FANG™ Vaccine autologous tumor cell vaccine Gradalis Carrollton, TX malignant melanoma (see also colorectal, ovarian) Phase II (214) 442-8100 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA malignant melanoma (see also breast, colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, stomach) Phase II (781) 274-8200 GDC-0973 (MEK inhibitor) Genentech South San Francisco, CA second-line metastatic malignant melanoma (combination therapy) (see also solid tumors) Phase I (800) 626-3553 Gleevec® imatinib Novartis Pharmaceuticals East Hanover, NJ malignant melanoma (see also lung, prostate, other) Phase II (888) 669-6682 GSK2118436 (BRaf protein kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC first-line BRAF mutation-positive latestage malignant melanoma (see also brain, lung) Phase III (888) 825-5249 -------------------------------------------------BRAF mutation-positive metastatic malignant melanoma (combination therapy) ------------------------------------------Phase II (888) 825-5249 GSK2241658A (cancer vaccine) GlaxoSmithKline Rsch. Triangle Park, NC metastatic malignant melanoma Phase I (888) 825-5249 GSK2302025A (cancer vaccine) GlaxoSmithKline Rsch. Triangle Park, NC first-line metastatic malignant melanoma Phase I (888) 825-5249 Medicines in Development Cancer 2012 87 Medicines in Development for Cancer Skin Cancer Product Name Sponsor Indication Development Status HyperAcute® Melanoma melanoma vaccine NewLink Genetics Ames, IA malignant melanoma Phase II (515) 296-5555 IMC-gp100 (cancer vaccine) Immunocore Oxon, United Kingdom malignant melanoma Phase 0 www.immunocore.com Imprime PGG® Biothera Eagan, MN malignant melanoma (see also colorectal, leukemia, lung) Phase I (651) 675-0300 INCB24360 Incyte Wilmington, DE malignant melanoma (see also solid tumors) Phase II (855) 446-2983 interleukin-12 gene therapy OncoSec Medical San Diego, CA malignant melanoma, merkel cell carcinoma (see also lymphoma) Phase II www.oncosec.com intetumumab Janssen Biotech Horsham, PA malignant melanoma (see also prostate) Phase I/II (800) 526-7736 LDE225 (erismodegib) Novartis Pharmaceuticals East Hanover, NJ basal cell cancer (see also leukemia, pancreatic, solid tumors) Phase II (888) 669-6682 LGK974 (WNT signaling pathway inhibitor) Novartis Pharmaceuticals East Hanover, NJ malignant melanoma (see also breast) Phase I (888) 669-6682 LGX818 (RAF inhibitor) Novartis Pharmaceuticals East Hanover, NJ metastatic malignant melanoma (see also colorectal) Phase I (888) 669-6682 Lymphoseek® Tc-99m tilmanocept Navidea Pharmaceuticals Dublin, OH malignant melanoma (diagnosis) (see also breast, head/neck) application submitted (614) 793-7500 M-200 prophage cancer vaccine (vitespen) (Orphan Drug) Agenus Lexington, MA metastatic melanoma (Fast Track) Phase III (781) 674-4400 Marqibo® vincristine liposomal (Orphan Drug) Talon Therapeutics San Mateo, CA malignant melanoma (see also leukemia, lymphoma, other) Phase II (650) 588-6404 melanoma DNA vaccine Ichor Medical Systems San Diego, CA Memorial Sloan-Kettering Cancer Center New York, NY malignant melanoma Phase I (858) 550-2022 MORAb-004 Eisai Woodcliff Lake, NJ malignant melanoma Phase II (888) 422-4743 88 Medicines in Development Cancer 2012 Medicines in Development for Cancer Skin Cancer Product Name Sponsor Indication Development Status muparfostat (PI-88) (Orphan Drug) Progen Pharmaceuticals Queensland, Australia malignant melanoma (see also liver) Phase II www.progen.com.au MVax® melanoma vaccine AVAX Technologies Philadelphia, PA malignant melanoma Phase III (215) 241-9760 NX-101 NexGenix New York, NY dermal neurofibromatoses Phase II (212) 974-3006 Ontak® denileukin diftitox Eisai Woodcliff Lake, NJ malignant melanoma Phase II (888) 422-4743 PEG arginine deiminase (ADI-PEG 20) Polaris Pharmaceuticals San Diego, CA metastatic malignant melanoma (see also liver, prostate, other) Phase II (858) 452-6688 Picato® ingenol mebutate LEO Pharma Parsippany, NJ basal cell cancer Phase II (877) 494-4536 POL-103A (melanoma vaccine) (Orphan Drug) Polynoma San Diego, CA malignant melanoma Phase III (858) 205-2501 PRAME antigen-specific cancer immunotherapeutic (recombinant) GlaxoSmithKline Rsch. Triangle Park, NC metastatic malignant melanoma (see also lung) Phase I (888) 825-5349 PTI-188 Pain Therapeutics Austin, TX malignant melanoma Phase I completed (512) 501-2444 PV-10 (rose bengal sodium) (Orphan Drug) Provectus Pharmaceuticals Knoxville, TN malignant melanoma (see also liver) Phase II completed (866) 594-5999 RAF265 (raf kinase inhibitor) Novartis Pharmaceuticals East Hanover, NJ malignant melanoma (see also solid tumors) Phase I (888) 669-6682 Reolysin® reovirus Oncolytics Biotech Calgary, Canada malignant melanoma (see also brain, colorectal, head/neck, lung, ovarian, pancreatic, sarcoma, solid tumors) Phase II (403) 670-7377 RG7256 (BRAF kinase inhibitor) Roche Nutley, NJ malignant melanoma Phase I (973) 235-5000 RG7636 (antibody drug conjugate) Roche Nutley, NJ malignant melanoma Phase I (800) 626-3553 Medicines in Development Cancer 2012 89 Medicines in Development for Cancer Skin Cancer Product Name Sponsor Indication Development Status talminogene laherparepvec Amgen Thousand Oaks, CA malignant melanoma Phase III (800) 772-6436 Tasigna® nilotinib Novartis Pharmaceuticals East Hanover, NJ malignant melanoma (c-Kit mutation) (see also leukemia, stomach) Phase III (888) 669-6682 tesetaxel (Orphan Drug) Genta Berkeley Heights, NJ malignant melanoma (see also bladder, breast, prostate, stomach) Phase II (908) 286-9800 TKI258 (dovitinib) Novartis Pharmaceuticals East Hanover, NJ malignant melanoma (see also breast, kidney, multiple myeloma, prostate, other) Phase I/II (888) 669-6682 TNFerade™ golnerminogene pradenovec GenVec Gaithersburg, MD malignant melanoma (see also head/neck, prostate, stomach) Phase II (877) 943-6832 trametinib GlaxoSmithKline Rsch. Triangle Park, NC malignant melanoma (monotherapy) (see also leukemia, lung, lymphoma, multiple myeloma, pancreatic) -------------------------------------------------malignant melanoma (combination therapy) Phase III (888) 825-5249 ------------------------------------------Phase II (888) 825-5249 veglin (VEGF antisense) VasGene Therapeutics Los Angeles, CA Kaposi’s sarcoma (see also lung, kidney) Phase I (323) 221-7818 YERVOY® ipilimumab Bristol-Myers Squibb Princeton, NJ melanoma (adjuvant therapy), melanoma brain metastases (see also lung, prostate) in clinical trials (800) 332-2056 Zadaxin® thymalfasin alfa 1 (Orphan Drug) SciClone Pharmaceuticals Foster City, CA malignant melanoma (see also liver) Phase II/III (650) 358-3456 Product Name Sponsor Indication Development Status AbGn-7 AbGenomics Los Altos, CA Phase I (650) 988-9912 ABI-009 (sirolimus albumin bound) Celgene Summit, NJ Phase I (908) 673-9000 Solid Tumors 90 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status ABT-348 (aurora kinase inhibitor) Abbott Laboratories Abbott Park, IL late-stage solid tumors (see also other) Phase I (847) 937-6100 ABT-700 (c-Met inhibitor) Abbott Laboratories Abbott Park, IL Phase I (847) 937-6100 ABT-767 (PARP inhibitor) Abbott Laboratories Abbott Park, IL Phase I (847) 937-6100 ABT-806 (EGFR inhibitor) Abbott Laboratories Abbott Park, IL Phase I (847) 937-6100 AC220 (quizartinib) Ambit Biosciences San Diego, CA Astellas Pharma US Deerfield, IL (see also leukemia) Phase I (858) 334-2100 (800) 695-4321 AEZS-112 AEterna Zentaris Basking Ridge, NJ (see also lymphoma) Phase I (908) 626-5428 AI-850 Acusphere Lexington, MA Phase I (617) 648-8800 ALB-109564(a) (tubulin inhibitor) AMRI Albany, NY Bessor Pharma Framingham, MA Phase I www.amriglobal.com AlloStim™ Immunovative Therapies Shoham, Israel (see also other) Phase I/II www.immunovative.co.il Alocrest™ vinorelbine liposomal Talon Therapeutics San Mateo, CA (see also lymphoma) Phase I (650) 588-6404 AMG 208 (c-Met inhibitor) Amgen Thousand Oaks, CA Phase I (800) 772-6436 AMG 337 (c-Met inhibitor) Amgen Thousand Oaks, CA Phase I (800) 772-6436 AMG 780 (angioprotein inhibitor) Amgen Thousand Oaks, CA Phase I (800) 772-6436 AMG 820 (c-fms antagonist) Amgen Thousand Oaks, CA Phase I (800) 772-6436 Medicines in Development Cancer 2012 91 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status AMG 900 (aurora kinase inhibitor) Amgen Thousand Oaks, CA (see also other) Phase I (800) 772-6436 AMP-224 Amplimmune Gaithersburg, MD Phase I (301) 309-9800 anti-CD137 (BMS-663513) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 anti-IGF-1R mAb Genentech South San Francisco, CA Phase I (800) 626-3553 anti-PD-L1 (BMS-936559) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 Aplidin® plitidepsin PharmaMar Madrid, Spain (see also lymphoma, multiple myeloma) Phase I www.pharmamar.com AR-12 Arno Therapeutics Flemington, NJ (see also lymphoma) Phase I (862) 703-7170 AR-67 Arno Therapeutics Flemington, NJ (see also brain, leukemia) Phase I (862) 703-7170 ARQ 092 (AKT inhibitor) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ inoperable/unresectable late-stage solid tumors Phase I (781) 994-0300 (973) 944-2600 ARQ 621 (Eg5 inhibitor) ArQule Woburn, MA late-stage solid tumors (see also other) Phase I (781) 994-0300 ARQ 736 (BRAF inhibitor) ArQule Woburn, MA late-stage solid tumors Phase I (781) 994-0300 ARQ 761 (E2F1 stimulant) ArQule Woburn, MA ARRY-162 (MEK inhibitor) Array BioPharma Boulder, CO late-stage solid tumors (see also skin) Phase I (877) 633-2436 ARRY-520 (KSP inhibitor) Array BioPharma Boulder, CO (see also leukemia, multiple myeloma) Phase I (877) 633-2436 92 Phase I (781) 994-0300 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor ASG-22ME Agensys Santa Monica, CA Seattle Genetics Bothell, WA ASP3026 Astellas Pharma US Deerfield, IL late-stage solid tumors (see also lymphoma) Phase I (800) 695-4321 AT7519 (CDK inhibitor) Astex Pharmaceuticals Dublin, CA (see also leukemia, lymphoma, multiple myeloma) Phase I (925) 560-0100 AT9283 (aurora/Jak2 inhibitor) Astex Pharmaceuticals Dublin, CA (see also leukemia, lymphoma, multiple myeloma) Phase I (925) 560-0100 AT13387 (Hsp90 inhibitor) Astex Pharmaceuticals Dublin, CA refractory solid tumors (see also stomach) Phase I (925) 560-0100 ATI-1123 (docetaxel liposomal) Azaya Therapeutics San Antonio, TX Phase I (210) 341-6600 AZD1480 (JAK1/JAK2 inhibitor) AstraZeneca Wilmington, DE Phase I (800) 236-9933 AZD2014 (TOR kinase inhibitor) AstraZeneca Wilmington, DE Phase I (800) 236-9933 AZD4547 (FGFR tyrosine kinase inhibitor) AstraZeneca Wilmington, DE Phase II (800) 236-9933 AZD5363 (AKT inhibitor) Astex Pharmaceuticals Dublin, CA AstraZeneca Wilmington, DE Phase I (800) 236-9933 AZD8330 (ARRY-424704) (MEK inhibitor) Array BioPharma Boulder, CO AstraZeneca Wilmington, DE Phase I (800) 236-9933 AZD8931 (erbB kinase inhibitor) AstraZeneca Wilmington, DE (see also breast) Phase II (800) 236-9933 BAY 10-00394 (Pan-CDK inhibitor) Bayer HealthCare Pharmaceuticals Wayne, NJ late-stage solid tumors Phase I (888) 842-2937 BAY 79-4620 (antibody-drug conjugate) Bayer HealthCare Pharmaceuticals Wayne, NJ Medicines in Development Cancer 2012 Indication Development Status Phase I (800) 695-4321 (425) 527-4000 Phase I (888) 842-2937 93 Medicines in Development for Cancer Solid Tumors Product Name Sponsor BAY 80-6946 Bayer HealthCare Pharmaceuticals Wayne, NJ Phase I (888) 842-2937 BAY 87-2243 (HIF-1ἀ pathway inhibitor) Bayer HealthCare Pharmaceuticals Wayne, NJ Phase I (888) 842-2937 BAY 94-9343 (antibody drug conjugate) Bayer HealthCare Pharmaceuticals Wayne, NJ Phase I (888) 842-2937 BBI503 (stemness kinase inhibitor) Boston Biomedical Norwood, MA late-stage solid tumors Phase I (781) 278-0900 BBI608 (stemness inhibitor) Boston Biomedical Norwood, MA late-stage solid tumors Phase I (781) 278-0900 belotecan OnKor Pharmaceuticals Seattle, WA Phase II (206) 694-4424 BEZ235 (kinase inhibitor) Novartis Pharmaceuticals East Hanover, NJ Phase I/II (888) 669-6682 BGJ398 (FGF-R kinase inhibitor) Novartis Pharmaceuticals East Hanover, NJ Phase I (888) 669-6682 BGT226 (MTOR/PI3K inhibitor) Novartis Pharmaceuticals East Hanover, NJ Phase I/II (888) 669-6682 BHQ880 (mAb) Novartis Pharmaceuticals East Hanover, NJ (see also multiple myeloma) Phase I (888) 669-6682 BI-811283 (aurora kinase B inhibitor) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT (see also leukemia) Phase I (800) 243-0127 BI-831266 Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Phase I (800) 243-0127 BI-836845 (IgG1-lambda) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Phase I (800) 243-0127 BI-847325 Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Phase I (800) 243-0127 94 Indication Development Status Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor BI-853520 (TYK2 inhibitor) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Phase I (800) 243-0127 BIIB 015 Biogen Idec Cambridge, MA Phase I completed (617) 679-2000 BIIB 028 Biogen Idec Cambridge, MA Phase I completed (617) 679-2000 BIND-014 (docetaxel nanopharmaceutical) BIND Biosciences Cambridge, MA Phase I (617) 491-3400 BMN-673 (PARP inhibitor) BioMarin Pharmaceuticals Novato, CA BQS481 (Eg5 inhibitor) Novartis Pharmaceuticals East Hanover, NJ BYL719 (PI3K-alpha inhibitor) Novartis Pharmaceuticals East Hanover, NJ late-stage solid tumors Phase I (888) 669-6682 CA-18C3 XBiotech Austin, TX (see also cancer-related, other) Phase I/II (512) 386-2900 CALAA 01 (siRNA) Calando Pharmaceuticals Pasadena, CA carfilzomib Onyx Pharmaceuticals South San Francisco, CA (see also multiple myeloma) Phase II (650) 266-0000 CBP-501 (peptide mimetic) CanBas Shizouka, Japan (see also lung) Phase I www.canbas.co.jp CC-115 (kinase inhibitor) Celgene Summit, NJ (see also lymphoma, multiple myeloma) Phase I (908) 673-9000 CC-122 Celgene Summit, NJ (see also lymphoma, multiple myeloma) Phase I (908) 673-9000 CDX-1127 Celldex Therapeutics Needham, MA (see also other) Phase I (781) 433-0771 CDX-1401 (cancer vaccine) Celldex Therapeutics Needham, MA solid tumors expressing the NY-ESO-1 protein Phase I/II (781) 433-0771 CEP-11981 (VEGF-R/TIE2 kinase inhibitor) Cephalon Frazer, PA Medicines in Development Cancer 2012 Indication (see also other) Development Status Phase I/II (415) 506-6700 Phase I (888) 669-6682 Phase I (626) 683-7200 Phase I completed (610) 344-0200 95 Medicines in Development for Cancer Solid Tumors Product Name Sponsor CG201 (cancer vaccine) CG Therapeutics Seattle, WA CRLX101 Cerulean Pharma Cambridge, MA crolibulin EpiCept Tarrytown, NY Phase I/II (914) 606-3500 CUDC-101 Curis Lexington, MA Phase I (617) 503-6500 CVX 060 (PF-04856884) (Ang2 antagonist) Pfizer New York, NY (see also kidney) Phase I (860) 732-5156 CX-4945 (CK2 inhibitor) Cylene Pharmaceuticals San Diego, CA (see also multiple myeloma) Phase I (858) 875-5100 CYC116 (aurora kinase/VEGFR2 inhibitor) Cyclacel Pharmaceuticals Berkeley Heights, NJ Phase I (908) 517-7330 CYT-6091 (Aurimune) CytImmune Sciences Rockville, MD Phase I (301) 825-3041 D-1MT NewLink Genetics Ames, IA D-3263 (TRPM8 protein stimulant) Dendreon Seattle, WA dacomitinib (PF-00299804) Pfizer New York, NY (see also lung) Phase II (860) 732-5156 darinaparsin (ZIO-101) ZIOPHARM Oncology New York, NY (see also liver, lymphoma, multiple myeloma) Phase I (646) 214-0700 DS-2248 Daiichi Sankyo Parsippany, NJ Phase I (973) 944-2600 DS-7423 Daiichi Sankyo Parsippany, NJ Phase I (973) 944-2600 96 Indication Development Status Phase II (206) 336-5604 late-stage solid tumors (see also breast) Phase I/II (617) 551-9600 Phase I (515) 296-5555 Phase I (877) 256-4545 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status E7050 Eisai Woodcliff Lake, NJ metastatic solid tumors (see also brain, head/neck, liver, skin, stomach) Phase I/II (888) 422-4743 EC17 Endocyte West Lafayette, IN Phase I www.endocyte.com EC0489 Endocyte West Lafayette, IN Phase I www.endocyte.com elsamitrucin Spectrum Pharmaceuticals Henderson, NV EMD-1214063 (c-Met kinase inhibitor) EMD Serono Rockland, MA Phase I (800) 283-8088 enavatuzumab Abbott Laboratories Abbott Park, IL Phase I (847) 937-6100 EP-100 Esperance Pharmaceuticals Baton Rouge, LA Phase I (225) 615-8944 ETBX-011 cancer vaccine Etubics Seattle, WA late-stage metastatic solid tumors Phase I (206) 838-5110 etirinotecan pegol (NKTR-102) Nektar Therapeutics San Francisco, CA combination therapy (see also breast, colorectal, ovarian) Phase I (855) 482-6587 EZN-2208 (PEG-SN38, firtecan pegol) Enzon Pharmaceuticals Piscataway, NJ solid tumors (pediatric) (see also breast, colorectal) -------------------------------------------------combination therapy Phase I/II (973) 980-4500 ------------------------------------------Phase I (973) 980-4500 EZN-2968 (HIF1-alpha inhibitor) Enzon Pharmaceuticals Piscataway, NJ (see also lymphoma) Phase I (973) 980-4500 ficlatuzumab (AV-299) AVEO Pharmaceuticals Cambridge, MA (see also lung) Phase I (617) 299-5000 fluciclatide F-18 GE Healthcare Waukesha, WI National Cancer Institute Bethesda, MD solid tumors (diagnosis) Phase II (262) 513-4000 FP-1039/HGS1036 Five Prime Therapeutics South San Francisco, CA Human Genome Sciences Rockville, MD late-stage solid tumors Phase I (415) 365-5600 (301) 309-8504 Medicines in Development Cancer 2012 late-stage solid tumors Phase I (702) 835-6300 97 Medicines in Development for Cancer Solid Tumors Product Name Sponsor G-202 GenSpera San Antonio, TX Phase I (210) 479-8112 GC1008 (fresolimumab) Genzyme Cambridge, MA Phase I (617) 252-7500 GDC-0032 (PI3 kinase inhibitor) Genentech South San Francisco, CA GDC-0068 (Akt inhibitor) Genentech South San Francisco, CA GDC-0349 (small molecule) Genentech South San Francisco, CA (see also lymphoma) Phase I (800) 626-3553 GDC-0425 (ChK1 inhibitor) Genentech South San Francisco, CA (see also lymphoma) Phase I (800) 626-3553 GDC-0575 Genentech South San Francisco, CA (see also lymphoma) Phase I (800) 626-3553 GDC-0623 (MEK inhibitor) Genentech South San Francisco, CA metastatic solid tumors Phase I (800) 626-3553 GDC-0917 (IAP antagonist) Genentech South San Francisco, CA (see also lymphoma) Phase I (800) 626-3553 GDC-0973 (MEK inhibitor) Genentech South San Francisco, CA (see also skin cancer) Phase I (800) 626-3553 GDC-0980 (PI3 kinase/mTOR dual inhibitor) Genentech South San Francisco, CA (see also breast, lymphoma) Phase I (800) 626-3553 Genz644282 (toposisomerase-1 inhibitor) Genzyme Cambridge, MA Phase I (800) 981-2491 GGTI-2418 Kirax Bonita Springs, FL Phase I (239) 444-5400 GI-6301 (brachyury peptide vaccine) GlobeImmune Louisville, CO Phase I (303) 625-2700 GL-ONC1 Genelux San Diego, CA Phase I (858) 483-0024 GO-203-2c Genus Oncology Vernon Hills, IL 98 Indication Development Status metastatic solid tumors Phase I (800) 626-3553 Phase I/II (800) 626-3553 late-stage solid tumors Phase I (847) 549-6500 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status GSK461364 (polio-like kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also lymphoma) Phase I (888) 825-5249 GSK690693 (AKT kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also lymphoma) Phase I (888) 825-5249 GSK1070916A (selective aurora kinase B/C inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC GSK2126458 (PI3K/mTOR inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also lymphoma) Phase I (888) 825-5249 GSK2141795 (protein kinase B inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC (see also lymphoma) Phase I (888) 825-5249 GSK2256098 (FAK inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC Phase I (888) 825-5249 GSK2636771 (PI3K beta-selective inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC Phase I (888) 825-5249 HSP990 (heat shock protein) Novartis Pharmaceuticals East Hanover, NJ Phase I (888) 669-6682 IGF-1R antagonist (BMS-754807) Bristol-Myers Squibb Princeton, NJ Phase II (800) 332-2056 IMF-001 (cancer vaccine) ImmunoFrontier Tokyo, Japan IMGN388 ImmunoGen Waltham, MA Phase I (781) 895-0600 INC280 (c-Met inhibitor) Novartis Pharmaceuticals East Hanover, NJ Phase I/II (888) 669-6682 INCB24360 Incyte Wilmington, DE (see also skin) Phase I/II (855) 446-2983 indium-111 (ABT-806) Abbott Laboratories Abbott Park, IL solid tumors (diagnosis) Phase I (847) 937-6100 INK128 (mTOR inhibitor) Intellikine La Jolla, CA (see also lymphoma, multiple myeloma) Phase I (858) 768-6500 INK1117 (PI3Kα inhibitor) Intellikine La Jolla, CA Medicines in Development Cancer 2012 Phase I (888) 825-5249 NY-ESO-1 antigen-expressing solid tumors Phase I www.immunofrontier.com Phase I (858) 768-6500 99 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status INNO-206 CytRx Los Angeles, CA (see also pancreatic, sarcoma) Phase I/II (310) 826-5648 INNO-305 (WT-1 vaccine) CytRx Los Angeles, CA (see also leukemia) Phase I (310) 826-5648 JI-101 (angiogenesis inhibitor) Jubilant Biosys Malvern, PA JNJ-26854165 (Hdm2 inhibitor) Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ JX-929 Jennerex Biotherapeutics San Francisco, CA Karenitecin® BNP1350 BioNumerik Pharmaceuticals San Antonio, TX solid tumors (adults and pediatric) (see also lung, ovarian) Phase I (210) 614-1701 KHK-2866 Kyowa Hakko Kirin Pharma Princeton, NJ advanced solid tumors (see also ovarian) Phase I (609) 919-1100 LBH589 (panobinostat) Novartis Pharmaceuticals East Hanover, NJ (see also kidney, leukemia, multiple myeloma, prostate) Phase I (888) 669-6682 LCI699 (aldosterone synthase inhibitor) Novartis Pharmaceuticals East Hanover, NJ Phase II (888) 669-6682 LCL161 (IAP inhibitor) Novartis Pharmaceuticals East Hanover, NJ Phase I (888) 669-6682 LDE225 (erismodegib) Novartis Pharmaceuticals East Hanover, NJ LDK378 (ALK inhibitor) Novartis Pharmaceuticals East Hanover, NJ LEE011 (CDK4/6 inhibitor) Novartis Pharmaceuticals East Hanover, NJ LEQ506 (Smo antagonist) Novartis Pharmaceuticals East Hanover, NJ Phase I (888) 669-6682 L-MDAM BioNumerik Pharmaceuticals San Antonio, TX Phase I (210) 614-1701 LOR 253 (MTF-1 inhibitor) Lorus Therapeutics Toronto, Canada 100 Phase I/II (610) 240-8690 late-stage solid tumors (see also lung, prostate) Phase I (800) 817-5286 Phase I (415) 281-8886 solid tumors (adults and pediatric) (see also leukemia, pancreatic, skin) Phase I (888) 669-6682 Phase I (888) 669-6682 (see also lymphoma) metastatic solid tumors Phase I (888) 669-6682 Phase I (416) 798-1200 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor LP-261 Locus Pharmaceuticals Blue Bell, PA lurbinectedin PharmaMar Madrid, Spain (see also leukemia) Phase I www.pharmamar.com ME-143 (NADH oxidase inhibitor) Marshall Edwards San Diego, CA refractory solid tumors Phase I (858) 792-6300 MEDI-565 (anti-CEA BiTE) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD Phase I (800) 236-9933 (301) 398-0000 MEDI-573 (anti-IGF mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD Phase I (800) 236-9933 (301) 398-0000 MEDI-0639 (anti-delta-like 4 mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD Phase I (800) 236-9933 (301) 398-0000 MEDI-3617 (anti-ANG-2 mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD Phase I (800) 236-9933 (301) 398-0000 MG-1102 Green Cross Yongin, South Korea Mogam Biotechnology Research Institute Yongin, South Korea second-line solid tumors Phase I www.eng.greencross.com MGA271 (anti-B7-H3) MacroGenics Rockville, MD refractory metastatic solid tumors Phase I (301) 251-5172 MGAH22 (anti-HER2 mAb) MacroGenics Rockville, MD Phase I (301) 251-5172 MINT1526A Genentech South San Francisco, CA Phase I (800) 626-3553 MK-1496 Merck Whitehouse Station, NJ Phase I completed (800) 672-6372 Medicines in Development Cancer 2012 Indication Development Status Phase I (215) 358-2000 101 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status MK-3475 Merck Whitehouse Station, NJ metastatic late-stage solid tumors Phase I (800) 672-6372 MK-4827 (PARP inhibitor) Merck Whitehouse Station, NJ Phase I (800) 672-6372 MK-5108/VX-689 (aurora kinase A inhibitor) Merck Whitehouse Station, NJ Vertex Pharmaceuticals Cambridge, MA Phase I (800) 672-6372 (617) 444-6100 MK-8242 Merck Whitehouse Station, NJ (see also leukemia) Phase I (800) 672-6372 MLN0128 Millennium Pharmaceuticals Cambridge, MA (see also other) Phase I (800) 390-5663 MLN0518 (tandutinib) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 MLN1117 Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 MLN2480 (raf kinase inhibitor) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 MLN4924 (NEDD8 inhibitor) Millennium Pharmaceuticals Cambridge, MA (see also other) Phase I (800) 390-5663 MLN8237 (alisertib) Millennium Pharmaceuticals Cambridge, MA (see also lymphoma) Phase II (800) 390-5663 MLN9708 (ixazomib) Millennium Pharmaceuticals Cambridge, MA (see also lymphoma, multiple myeloma) Phase I (800) 390-5663 MM-151 (EGFR antagonist) Merrimack Pharmaceuticals Cambridge, MA mocetinostat (MGCD0103, HDAC inhibitor) MethylGene Montreal, Canada MPDL-3280A Genentech South San Francisco, CA 102 Phase I (617) 441-1000 (see also leukemia, lymphoma) Phase I/II (514) 337-3333 Phase I (800) 626-3553 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor MSC2015103B (MEK inhibitor) EMD Serono Rockland, MA Phase I (800) 283-8088 MTKi-328 BeiGene Beijing, China Phase I www.beigene.com MTRN-2696 Spectrum Pharmaceuticals Henderson, NV Phase I (702) 835-6300 NKP-1339 Niiki Pharma Hoboken, NJ Phase I (201) 710-5512 NKTR-105 (pegylated docetaxel) Nektar Therapeutics San Francisco, CA Phase I (415) 482-5300 NMS-1116354 (CDC7 protein kinase inhibitor) Nerviano Medical Services Nerviano, Italy Phase I www.nervianoms.com NMS-1286937 (PIK-1 inhibitor) Nerviano Medical Services Nerviano, Italy Phase I www.nervianoms.com NPI-0052 (marizomib) Nereus Pharmaceuticals San Diego, CA olaparib (PARP inhibitor) AstraZeneca Wilmington, DE Omapro™ omacetaxine Cephalon Frazer, PA OMP-18R5 (Wnt pathway) Bayer HealthCare Pharmaceuticals Wayne, NJ OncoMed Pharmaceuticals Redwood City, CA Phase I (888) 842-2837 (650) 995-8200 OMP-21M18 (DLL4 inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC OncoMed Pharmaceuticals Redwood City, CA Phase I (888) 825-5249 (650) 995-8200 OMP-59R5 (notch pathway) GlaxoSmithKline Rsch. Triangle Park, NC OncoMed Pharmaceuticals Redwood City, CA Phase I (888) 825-5249 (650) 995-8200 omtriptolide Pharmagenesis Redwood City, CA Pierre Fabre Pharmaceuticals Parsippany, NJ Phase I (650) 842-7060 www.pierre-fabre.com Medicines in Development Cancer 2012 Indication (see also lymphoma, multiple myeloma) Development Status Phase I (858) 587-4090 Phase I (800) 236-9933 (see also leukemia) Phase II (610) 344-0200 103 Medicines in Development for Cancer Solid Tumors Product Name Sponsor ONT-10 (cancer vaccine) Oncothyreon Seattle, WA Phase I (206) 769-9219 ONX-0801 Onyx Pharmaceuticals South San Francisco, CA Phase I (650) 266-0000 OPB-51602 Otsuka America Pharmaceutical Rockville, MD Phase I (800) 562-3974 oprozomib Onyx Pharmaceuticals South San Francisco, CA Phase I (650) 266-0000 oral azacitidine Celgene Summit, NJ (see also leukemia, lung, lymphoma) Phase II (908) 673-9000 ortataxel Spectrum Pharmaceuticals Henderson, NV taxane-refractory solid tumors Phase II (702) 835-6300 OSI-930 (c-kit/VEGFR-2) OSI Pharmaceuticals Farmingdale, NY Phase I (631) 962-0600 p28 peptide CDG Therapeutics Chicago, IL Phase I www.cdgti.com paclitaxel liposomal Sun Pharma Mumbai, India Phase I www.sunpharma.com palifosfamide (ZIO-201) ZIOPHARM Oncology New York, NY pbi-shRNA™ STMN1 LP (anti-stathim gene therapy) Gradalis Carrollton, TX perifosine AEterna Zentaris Basking Ridge, NJ PF-00337210 (VEGFR2 antagonist) Pfizer New York, NY Phase I completed (860) 732-5156 PF-03446962 (ALK-1 mAb) Pfizer New York, NY Phase I (860) 732-5156 104 Indication Development Status (see also lung, sarcoma) Phase I (646) 214-0700 Phase I (214) 442-8100 solid tumors (pediatric) (see also brain, colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, stomach) Phase I (908) 626-5428 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor PF-04605412 (anti-α5β1 integrin mAb) Pfizer New York, NY PF-04691502 (PI3K/mTOR inhibitor) Pfizer New York, NY (see also other) Phase I (860) 732-5156 PF-05212384 (mTOR/PI3K inhibitor) Pfizer New York, NY (see also other) Phase I (860) 732-5156 PG11047 Progen Pharmaceuticals Queensland, Australia (see also lymphoma) Phase I www.progen-pharma.com PLX3397 (CSF-1R kinase inhibitor) Plexxikon Berkeley, CA metastatic solid tumors (see also brain, leukemia, lymphoma) Phase I (510) 647-4000 PM-060184 PharmaMar Madrid, Spain Phase I www.pharmamar.com PNT2258 (bcl-2 oncogene inhibitor) ProNAi Therapeutics Ann Arbor, MI Phase I (269) 815-8098 PRI-724 (CBP/catenin inhibitor) PRISM BioLab Yokohama, Japan Phase I www.prismbiolab.com PRLX93936 Prolexys Pharmaceuticals Salt Lake City, UT Phase I PTC299 PTC Therapeutics South Plainfield, NJ purine nucleoside phosphorylase gene therapy PNP Therapeutics Birmingham, AL Phase I www.pnptherapeutics.com PWT33597 (PI3K alpha/mTOR kinase) Pathway Therapeutics San Francisco, CA Phase I www.pathwaytx.com QBI-139 Quintessence Biosciences Madison, WI Phase I (608) 441-2950 RAF265 (raf kinase inhibitor) Novartis Pharmaceuticals East Hanover, NJ Medicines in Development Cancer 2012 Indication Development Status Phase I (860) 732-5156 (see also breast, other) (see also skin) Phase II (908) 222-7000 Phase I/II (888) 669-6682 105 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status regorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ (see also colorectal, kidney, lung, stomach) Phase I (888) 842-2837 Reolysin® reovirus Oncolytics Biotech Calgary, Canada solid tumors (pediatric) (see also brain, colorectal, head/neck, lung, ovarian, pancreatic, sarcoma, skin) Phase I (403) 670-7377 RG7112 (MDM2 antagonist) Roche Nutley, NJ (see also other) Phase I (973) 235-5000 RG7116 (ErbB-3 receptor antagonist) Roche Nutley, NJ Phase I (973) 235-5000 RG7155 (anti-CSF-1R mAb) Roche Nutley, NJ Phase I (973) 235-5000 RG7167 (CIF/MEK inhibitor) Roche Nutley, NJ Phase I (973) 235-5000 RG7304 (MAP/raf inhibitor) Roche Nutley, NJ Phase I (973) 235-5000 RG7321 (PI3Kα inhibitor) Genentech South San Francisco, CA Roche Nutley, NJ Phase II (800) 626-3553 (973) 235-5000 RG7347 (NRP1 antagonist) Genentech South San Francisco, CA Roche Nutley, NJ Phase I (800) 626-3553 (973) 235-5000 RG7356 (CD44 antigen inhibitor) Roche Nutley, NJ Phase I (973) 235-5000 RG7388 (MDM2 inhibitor) Roche Nutley, NJ (see also other) Phase I (973) 235-5000 RG7444 (HFGR-1877S) Genentech South San Francisco, CA (see also multiple myeloma) Phase I (800) 626-3553 RG7446 (mAb) Genentech South San Francisco, CA RG7594 (mAb) Genentech South San Francisco, CA 106 Phase I (800) 626-3553 advanced solid tumors Phase I (800) 626-3553 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status RG7602 Genentech South San Francisco, CA (see also lymphoma) Phase I (800) 626-3553 robatumumab Merck Whitehouse Station, NJ solid tumors (combination therapy) (see also colorectal, sarcoma) -------------------------------------------------solid tumors (pediatric) Phase II (800) 672-6372 ------------------------------------------Phase I (800) 672-6372 RRx-001 RadioRx Mountain View, CA sapacitabine (CYC682) Cyclacel Pharmaceuticals Berkeley Heights, NJ SAR125844 (Met kinase inhibitor) Sanofi US Bridgewater, NJ Phase I (800) 981-2491 SAR153192 (anti-DLL4 mAb) Sanofi US Bridgewater, NJ Phase I (800) 981-2491 SAR245408/MSC1936369B combination therapy (PI3K inhibitor/MEK inhibitor) Merck Serono Geneva, Switzerland Sanofi US Bridgewater, NJ Phase I (800) 981-2491 SAR245409/MSC1936369B combination therapy (PI3K-mTOR inhibitor/MEK inhibitor) Merck Serono Geneva, Switzerland Sanofi US Bridgewater, NJ Phase I (800) 981-2491 SAR256212 (MM-121) companion diagnostic Merrimack Pharmaceuticals Cambridge, MA Sanofi US Bridgewater, NJ SAR307746 (REGN910) (anti-Ang2 mAb) Regeneron Pharmaceuticals Tarrytown, NY Sanofi US Bridgewater, NJ SAR566658 (maytansin-loaded anti-DS6) Sanofi US Bridgewater, NJ DS6-positive solid tumors Phase I (800) 981-2491 SB989 (pracinostat) S*BIO Oakland, CA late-stage solid tumors (see also leukemia, other) Phase I (650) 730-2860 Medicines in Development Cancer 2012 Phase I (650) 681-9885 (see also leukemia, lung) solid tumors (diagnosis) Phase I (908) 517-7330 Phase II (800) 981-2491 Phase I (914) 347-7000 (800) 981-2491 107 Medicines in Development for Cancer Solid Tumors Product Name Sponsor SCH-900353 Merck Whitehouse Station, NJ seliciclib (CYC202) Cyclacel Pharmaceuticals Berkeley Heights, NJ selumetinib (AZD6244/ARRY-142886) (MEK inhibitor) AstraZeneca Wilmington, DE Phase II (800) 236-9933 selumetinib (AZD6244/ARRY-142886)/ MK2206 combination (MEK/AKT inhibitor) AstraZeneca Wilmington, DE Merck Whitehouse Station, NJ Phase I (800) 236-9933 (800) 672-6372 SF1126 Semafore Pharmaceuticals Indianapolis, IN simotaxel IV Taxolog Fairfield, NJ Phase I (866) 829-6564 solid tumor immunotherapy (mAb) Genentech South San Francisco, CA Phase I (800) 626-3553 sonepcizumab Lpath San Diego, CA Phase I (858) 678-0800 SPI-1620 (endothelin B receptor agonist) Spectrum Pharmaceuticals Henderson, NV Phase I (702) 835-6300 TAG vaccine Gradalis Carrollton, TX Phase I (214) 442-8100 TAK-385 (gonadotrophin hormone-releasing hormone receptor antagonist) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 TAK-441 (hedgehog signaling pathway inhibitor) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 TAK-701 (HGF inhibitor) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 TAK-733 (MEK inhibitor) Millennium Pharmaceuticals Cambridge, MA Phase I (800) 390-5663 108 Indication Development Status Phase I (800) 672-6372 (see also head/neck) (see also leukemia, multiple myeloma) Phase I (908) 517-7330 Phase I (317) 876-3075 Medicines in Development Cancer 2012 Medicines in Development for Cancer Solid Tumors Product Name Sponsor TAK-960 (Plk1 inhibitor) Millennium Pharmaceuticals Cambridge, MA teglarinad Cephalon Frazer, PA (see also lymphoma) Phase I (610) 344-0200 terameprocol Erimos Pharmaceuticals Houston, TX solid tumors (IV-infusion) (see also brain, cervical, head/neck, other) Phase I (713) 541-2000 TKM-PLK1 (RNAi) Tekmira Pharmaceuticals Burnaby, Canada (see also lymphoma) Phase I (604) 419-3200 TL-32711 (birinapant) TetraLogic Pharmaceuticals Malvern, PA (see also leukemia) Phase I/II (610) 889-9900 TLC-388 TLC Biopharmaceuticals South San Francisco, CA Phase I (650) 872-8816 TRC093 (IgG1 mAb) TRACON Pharmaceuticals San Diego, CA Phase I completed (858) 550-0780 TRC102 (DNA repair inhibitor) TRACON Pharmaceuticals San Diego, CA Phase I (858) 550-0780 tremelimumab (anti-CTLA4 mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD Phase II (800) 236-9933 (301) 398-0000 TST-10088 Cangene Winnipeg, Canada Phase I (204) 275-4200 U3-1565 (anti-HB-EGF antibody) Amgen Thousand Oaks, CA Daiichi Sankyo US Parsippany, NJ Phase I (800) 772-6436 (973) 944-2600 UNBS-5162 Drais Pharmaceuticals Bridgewater, NJ V934/V935 Merck Whitehouse Station, NJ Phase I completed (800) 672-6372 V935 (telomerase inhibitor vaccine) Geron Menlo Park, CA Merck Whitehouse Station, NJ Phase I (650) 473-7700 (800) 672-6372 Medicines in Development Cancer 2012 Indication Development Status Phase I (800) 390-5663 (see also lymphoma) Phase I (908) 895-1200 109 Medicines in Development for Cancer Solid Tumors Product Name Sponsor Indication Development Status VGX-100 (VEGF-C mAb) Circadian Technologies Victoria, Australia VTX-2337 VentiRx Pharmaceuticals Seattle, WA VX15 Vaccinex Rochester, NY Phase I (585) 271-2700 WX-UK1 Wilex Munich, Germany Phase I www.wilex.de X-82 (dual VEGFR/PDGFR inhibitor) Tyrogenex West Palm Beach, FL advanced solid tumors Phase I (561) 835-9356 Xalkori® crizotinib Pfizer New York, NY (see also lung) Phase I (860) 732-5156 XMT-1001 Mersana Therapeutics Cambridge, MA Phase I (617) 498-0020 XMT-1107 Mersana Therapeutics Cambridge, MA Phase I (617) 498-0020 Phase I www.circadian.com.au (see also lymphoma) Phase I (206) 689-2259 Stomach Cancer Product Name Sponsor Indication Development Status AT-101 (oral pan Bcl-2 inhibitor) Ascenta Therapeutics Malvern, PA late-stage esophageal cancer (combination therapy) (see also brain, leukemia, lung, lymphoma, prostate) Phase I/II (610) 408-0301 AT13387 (Hsp90 inhibitor) Astex Pharmaceuticals Dublin, CA late-stage gastrointestinal stromal tumors (GIST) (second-line therapy) (see also solid tumors) Phase II (925) 560-0100 AUY922 (Hsp90 inhibitor) Novartis Pharmaceuticals East Hanover, NJ second-line GIST (see also breast, colorectal, lung, multiple myeloma) Phase II (888) 669-6682 BIIB 2024 Biogen Idec Cambridge, MA GIST (see also breast) Phase II completed (617) 679-2000 110 Medicines in Development Cancer 2012 Medicines in Development for Cancer Stomach Cancer Product Name Sponsor Indication Development Status crenolanib (CP-868-596) AROG Pharmaceuticals Dallas, TX GIST (see also brain) Phase II (214) 594-0002 E7050 Eisai Woodcliff Lake, NJ gastric cancer (combination therapy) (see also brain, head/neck, liver, skin, solid tumors) Phase I/II (888) 422-4743 ERBITUX® cetuximab Bristol-Myers Squibb Princeton, NJ Eli Lilly Indianapolis, IN gastric cancer (see also colorectal) in clinical trials (800) 332-2056 (800) 545-5979 ganetespib (Hsp90i) Synta Pharmaceuticals Lexington, MA esophageal cancer, gastric cancer, GIST (see also breast, colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin) Phase II (781) 274-8200 masitinib (Orphan Drug) AB Science USA Short Hills, NJ GIST (see also pancreatic) Phase III (973) 218-2437 Opaxio™ paclitaxel poliglumex Cell Therapeutics Seattle, WA esophageal cancer (see also brain, lung, ovarian, other) Phase II (800) 215-2355 perifosine AEterna Zentaris Basking Ridge, NJ GIST (see also brain, colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors) Phase II (908) 626-5428 polyclonal antibody stimulator (Orphan Drug) Cancer Advances Durham, NC gastric cancer (see also colorectal, pancreatic) Phase III (919) 361-2162 ramucirumab (IMC-1121B) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ gastric cancer (see also breast, colorectal) Phase III (800) 545-5979 regorafenib (Orphan Drug) Bayer HealthCare Pharmaceuticals Wayne, NJ GIST (Fast Track) (see also colorectal, kidney, lung, solid tumors) Phase III (888) 842-2837 S-1 Taiho Pharma U.S.A. Princeton, NJ gastric cancer Phase III (609) 750-5300 Tasigna® nilotinib (Orphan Drug) Novartis Pharmaceuticals East Hanover, NJ GIST (see also leukemia, skin) Phase III (888) 669-6682 Medicines in Development Cancer 2012 111 Medicines in Development for Cancer Stomach Cancer Product Name Sponsor Indication Development Status telatinib (Orphan Drug) ACT Biotech San Francisco, CA gastric cancer (combination therapy) (see also colorectal) Phase II (415) 230-3900 tesetaxel (Orphan Drug) Genta Berkeley Heights, NJ gastric cancer (see also bladder, breast, prostate, skin) Phase II (908) 286-9800 TNFerade™ golnerminogene pradenovac GenVec Gaithersburg, MD esophageal cancer (see also head/neck, prostate, skin) Phase II (877) 943-6832 trebananib (AMG386) Amgen Thousand Oaks, CA esophageal cancer, gastric cancer (see also breast, colorectal, kidney, liver, ovarian, other) Phase II (800) 772-6436 Tykerb® lapatinib GlaxoSmithKline Rsch. Triangle Park, NC gastric cancer (see also breast, head/neck) Phase III (888) 825-5249 uridine triacetate (PN401) Wellstat Therapeutics Gaithersburg, MD gastric cancer (see also pancreatic) Phase II (240) 631-2500 Xeloda® capecitabine Genentech South San Francisco, CA esophageal cancer (see also brain, colorectal, liver) Phase II (800) 626-3553 Cancer/Chemotherapy-Related Conditions Product Name Sponsor Indication Development Status AG103 ActoGenix Zwijnaarde, Belgium oral mucositis associated with cancer treatment Phase I www.actogenix.com AP1903 Bellicum Pharmaceuticals Houston, TX graft-versus-host disease (see also prostate) Phase I (713) 341-6472 ARX-02 (sufentanil sublingual) AcelRx Pharmaceuticals Redwood City, CA breakthrough cancer pain Phase II (650) 216-3500 CA-18C3 XBiotech Austin, TX cancer-related cachexia (see also other, solid tumors) Phase I/II (512) 386-2900 112 Medicines in Development Cancer 2012 Medicines in Development for Cancer Cancer/Chemotherapy-Related Conditions Product Name Sponsor Indication Development Status CD1400 (oltipraz) Canopus BioPharma Studio City, CA chemotherapy- and radiation-induced mucositis Phase II www.canopusbiopharma.com CLT-008 Cellerant Therapeutics San Carlos, CA chemotherapy-related neutropenia (see also other) Phase I/II (650) 232-2122 dronabinol oral solution INSYS Therapeutics Phoenix, AZ chemotherapy-induced nausea and vomiting Phase III (602) 910-2617 E6014 Eisai Woodcliff Lake, NJ oral mucositis Phase III (888) 422-4743 Emend® aprepitant Merck Whitehouse Station, NJ chemotherapy-induced nausea and vomiting (pediatric) Phase III (800) 672-6372 Emend® IV aprepitant Merck Whitehouse Station, NJ chemotherapy-induced nausea and vomiting (pediatric) Phase I (800) 672-6372 fentanyl inhalation Akela Pharma Austin, TX cancer pain Phase II/III (512 834-0449 ferroportin mAb Eli Lilly Indianapolis, IN anemia associated with cancer Phase I (800) 545-5979 fulranumab Johnson & Johnson Pharmaceutical Research & Development Raritan, NJ cancer pain (adjunctive treatment) Phase II (800) 817-5286 hepcidin mAb Eli Lilly Indianapolis, IN anemia associated with cancer Phase I (800) 545-5979 LG631 Lentigen Gaithersburg, MD chemoprotection in patients undergoing treatment for glioblastoma Phase I (301) 527-4200 mesenchymal stem cell therapy (Orphan Drug) Mesoblast New York, NY for bone marrow regeneration in patients undergoing bone marrow transplantation Phase III (212) 880-2060 morphine intranasal Marina Biotech Bothell, WA cancer pain Phase II (425) 908-3600 MultiStem® stem cell therapy (Orphan Drug) Athersys Cleveland, OH graft-versus-host disease in patients undergoing bone marrow transplant Phase I (216) 431-9900 Medicines in Development Cancer 2012 113 Medicines in Development for Cancer Cancer/Chemotherapy-Related Conditions Product Name Sponsor Indication Development Status nabiximols Otsuka America Pharmaceutical Rockville, MD cancer pain (adjunctive treatment) Phase III (800) 562-3974 netupitant/palonosetron Helsinn Therapeutics Bridgewater, NJ chemotherapy-induced nausea and vomiting Phase III (908) 231-1435 NP-2 gene therapy (intradermal) Diamyd Medical Pittsburgh, PA cancer pain Phase II (412) 770-1310 Nplate® romiplostim Amgen Thousand Oaks, CA chemotherapy-associated thrombocytopenia Phase II (800) 772-6436 PHY906 PhytoCeutica New Haven, CT chemotherapy-induced gastrointestinal disorders (see also colorectal, liver, pancreatic) Phase I/II (203) 777-3462 Prochymal® remestemcel-L (Orphan Drug) Osiris Therapeutics Columbia, MD graft-versus-host disease Phase III (443) 545-1800 ProDermaCel™ norepinephrine topical ProCertus BioPharm Madison, WI prevention of oral mucositis, prevention of radiation-induced skin damage Phase I/II (608) 273-8862 Promacta® eltrombopag GlaxoSmithKline Rsch. Triangle Park, NC chemotherapy-induced thrombocytopenia Phase II (888) 669-6682 RGI-2001 REGiMMUNE Santa Clara, CA graft-versus-host disease Phase I/II www.regimmune.com rolapitant TESARO Waltham, MA chemotherapy-induced nausea and vomiting Phase III (339) 970-0900 SGX201 Soligenix Princeton, NJ acute radiation enteritis in patients with cancer Phase I/II (609) 538-8200 sotatercept (ACE-011) Celgene Summit, NJ chemotherapy-induced anemia (see also other) Phase II/III (908) 673-9000 tanezumab Pfizer New York, NY cancer pain (adjunctive treatment) Phase II (860) 732-5156 Tavocept® dimesna BioNumerik Pharmaceuticals San Antonio, TX chemoprotection (see also lung) Phase III (210) 614-1701 114 Medicines in Development Cancer 2012 Medicines in Development for Cancer Cancer/Chemotherapy-Related Conditions Product Name Sponsor Indication Development Status T-cell replacement therapy Bellicum Pharmaceuticals Houston, TX graft-versus-host disease in patients with late-stage cancer undergoing bone marrow transplantation Phase I (713) 341-6472 TH-9402 (Orphan Drug) Kiadis Pharma Amsterdam, Netherlands graft-versus-host disease Phase I/II www.kiadis.com TXA127 Tarix Pharmaceuticals Cambridge, MA chemotherapy-induced thrombocytopenia Phase II www.tarixpharma.com Velcade® bortezomib Millennium Pharmaceuticals Cambridge, MA steroid-refractory graft-versus-host disease (see also leukemia, lymphoma, other) Phase II (800) 390-5663 XEN-2174 Xenome Queensland, Australia cancer pain Phase II www.xenome.com Xgeva™ denosumab Amgen Thousand Oaks, CA prevention of cancer-related bone damage or malignant hypercalcemia (see also multiple myeloma, other) Phase III (800) 772-6436 Product Name Sponsor Indication Development Status 8H9 I-131 mAb United Therapeutics Silver Spring, MD peritoneal cancer (see also brain, sarcoma) Phase I (301) 608-9292 Å6 Angstrom Pharmaceuticals Solana Beach, CA gynecologic cancer (see also ovarian) Phase I (858) 314-2356 ABT-348 (aurora kinase inhibitor) Abbott Laboratories Abbott Park, IL hematological malignancies (see also solid tumors) Phase I (847) 937-6100 ABT-888 (veliparib) (PARP inhibitor) Abbott Laboratories Abbott Park, IL fallopian tube cancer (see also brain, breast, colorectal, lung, lymphoma, ovarian, prostate, skin) Phase II (847) 937-6100 AEZS-108 AEterna Zentaris Basking Ridge, NJ late-stage endometrial cancer (see also bladder, ovarian, prostate) Phase II (908) 626-5428 AlloStim™ Immunovative Therapies Shoham, Israel hematological malignancies (see also solid tumors) Phase I/II www.immunovative.co.il Other Cancers Medicines in Development Cancer 2012 115 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status Alpharadin® radium-223 chloride Bayer HealthCare Pharmaceuticals Wayne, NJ bone metastases from castration-resistant prostate cancer (see also solid tumors) application submitted (888) 842-2837 ALT-801 Altor BioScience Miramar, FL urogenital cancer (see also skin) Phase I/II (954) 443-8600 AMG 319 (PI3K-delta inhibitor) Amgen Thousand Oaks, CA hematological malignancies Phase I (800) 772-6436 AMG 900 (aurora kinase inhibitor) Amgen Thousand Oaks, CA hematological malignancies (see also solid tumors) Phase I (800) 772-6436 anti-CD70 ADC (BMS-936561) Bristol-Myers Squibb Princeton, NJ hematological malignancies Phase I (800) 332-2056 anti-CXCR4 (BMS-936564) Bristol-Myers Squibb Princeton, NJ hematological malignancies Phase I (800) 332-2056 ARQ 621 (Eg5 inhibitor) ArQule Woburn, MA hematological malignancies (see also solid tumors) Phase I (781) 994-0300 Avastin® bevacizumab Genentech South San Francisco, CA high-risk carcinoid tumor (see also brain, breast, colorectal, lung, ovarian) Phase III (800) 626-3553 BAY 10-02670 Bayer HealthCare Pharmaceuticals Wayne, NJ uterine leiomyoma Phase I (888) 842-2937 belinostat Spectrum Pharmaceuticals Henderson, NV peritoneal cancer, thymoma (see also colorectal, leukemia, liver, lung, lymphoma, ovarian) -------------------------------------------------first-line thymoma Phase II (702) 835-6300 -------------------------------------------------recurrent hematological malignancies (combination therapy) ------------------------------------------Phase I/II (702) 835-6300 ------------------------------------------Phase I (702) 835-6300 BKM120 (PI3K inhibitor) Novartis Pharmaceuticals East Hanover, NJ second-line endometrial cancer, second-line urogenital cancer (see also brain, breast, lung) Phase II (888) 669-6682 BMN-673 (PARP inhibitor) BioMarin Pharmaceuticals Novato, CA hematological malignancies Phase I (415) 506-6700 116 Medicines in Development Cancer 2012 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status BP-100-1-01 Bio-Path Ogden, Utah hematological malignancies Phase I (801) 580-2326 CA-18C3 XBiotech Austin, TX hematological malignancies (see also cancer-related, solid tumors) Phase I (512) 386-2900 cabozantinib (XL184) (Orphan Drug) Exelixis South San Francisco, CA medullary thyroid cancer (see also breast, kidney, lung, ovarian, prostate) Phase III (650) 837-7000 catumaxomab Fresenius Biotech North America Waltham, MA malignant ascites (see also ovarian) Phase II www.fresenius-biotech.com CDX-1127 Celldex Therapeutics Needham, MA hematological malignancies (see also solid tumors) Phase I (781) 433-0771 clodronic acid Bayer HealthCare Pharmaceuticals Wayne, NJ bone metastases Phase III (888) 842-2937 CLT-008 Cellerant Therapeutics San Carlos, CA hematological malignancies (see also cancer-related) Phase I (650) 232-2122 CPI-613 (Orphan Drug) Cornerstone Pharmaceuticals Cranbury, NJ hematological malignancies (see also pancreatic) Phase I (609) 409-7050 dalotuzumab (MK-0646) Merck Whitehouse Station, NJ neuroendocrine tumors (see also breast, lung, pancreatic) Phase II (800) 672-6372 DMUC-5754A Genentech South San Francisco, CA first-line fallopian tube cancer, second-line peritoneal cancer (see also ovarian) Phase I (800) 626-3553 DN24-02 (lapuleucel-T) dendritic cell vaccine Dendreon Seattle, WA high-risk, HER2-positive urogenital cancer (adjuvant therapy) Phase II (877) 256-4545 E7080 (lenvatinib) Eisai Woodcliff Lake, NJ thyroid cancer (see also brain, skin) -------------------------------------------------endometrial cancer Phase III (888) 422-4743 ------------------------------------------Phase II (888) 422-4743 E7850 (irofulven) Eisai Woodcliff Lake, NJ thyroid cancer (see also ovarian, prostate) Phase II (888) 422-4743 efatutazone Daiichi Sankyo Parsippany, NJ thyroid cancer (see also colorectal, lung) Phase I/II (973) 944-2600 Medicines in Development Cancer 2012 117 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status EGEN-001 EGEN Huntsville, AL fallopian tube cancer, peritoneal cancer (see also colorectal, ovarian) Phase II (256) 512-0077 elagolix Abbott Laboratories Abbott Park, IL Neurocrine Biosciences San Diego, CA uterine leiomyoma Phase II (847) 938-6100 (858) 617-7600 ENMD-2076 EntreMed Rockville, MD late-stage cancer (see also multiple myeloma, ovarian) Phase I (240) 864-2600 Femara® letrozole Novartis Pharmaceuticals East Hanover, NJ recurrent, metastatic endometrial cancer (combination therapy) Phase II (888) 669-6682 folate binding protein (E39) vaccine Galena Biopharma Lake Oswego, OR endometrial cancer (see also breast, ovarian) Phase I/II (855) 855-4253 fostamatinib (SYK inhibitor) AstraZeneca Wilmington, DE Rigel Pharmaceuticals South San Francisco, CA hematological malignancies Phase II (800) 236-9933 (650) 624-1100 Gleevec® imatinib Novartis Pharmaceuticals East Hanover, NJ fibroma (see also lung, prostate, skin) Phase II (888) 669-6682 Inlyta® axitinib Pfizer New York, NY thyroid cancer (see also kidney, liver) Phase II (860) 732-5156 IPI-145 Infinity Pharmaceuticals Cambridge, MA hematological malignancies Phase I (617) 453-1000 Istodax® romidepsin Celgene Summit, NJ hematological malignancies (see also kidney, pancreatic, prostate) Phase I (908) 673-9000 IXEMPRA® ixabepilone Bristol-Myers Squibb Princeton, NJ endometrial cancer in clinical trials (800) 332-2056 Jakafi™ ruxolitinib Incyte Wilmington, DE hematological malignancies (see also pancreatic) Phase II (855) 446-2983 KB004 KaloBios Pharmaceuticals South San Francisco, CA hematological malignancies Phase I (650) 243-3100 Marqibo® vincristine liposomal Talon Therapeutics San Mateo, CA pediatric cancers (see also leukemia, lymphoma, skin) Phase I/II (650) 588-6404 118 Medicines in Development Cancer 2012 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status MEDI-551 (anti-CD19 mAb) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD hematological malignancies Phase I (800) 236-9933 (301) 398-0000 MER-101 (zoledronic acid oral) Merrion Pharmaceuticals Wilmington, NC bone metastases Phase II www/merrionpharma.com Mirena® levonorgestrel-releasing intrauterine system Bayer HealthCare Pharmaceuticals Wayne, PA endometrial cancer, endometrial hyperplasia Phase II (888) 842-2937 MK-0752 (notch signaling pathway inhibitor) Merck Whitehouse Station, NJ central nervous system (CNS) cancer in patients ages 3-21 (see also breast) Phase I (800) 672-6372 MK-2206 (c-akt inhibitor) Merck Whitehouse Station, NJ inoperable/unresectable neuroendocrine tumors (see also breast) Phase II (800) 672-6372 MLN0128 Millennium Pharmaceuticals Cambridge, MA hematological malignancies (see also solid tumors) Phase I (800) 390-5663 MLN4924 (NEDD8 inhibitor) Millennium Pharmaceuticals Cambridge, MA hematological malignancies (see aslo solid tumors) Phase I (800) 390-5663 motesanib Amgen Thousand Oaks, CA thyroid cancer (see also breast, colorectal, lung) Phase II (800) 772-6436 moxetumomab pasudotox (CAT-8015) AstraZeneca Wilmington, DE MedImmune Gaithersburg, MD hematological malignancies Phase I (800) 236-9933 (301) 398-0000 MSC1936369B EMD Serono Rockland, MA hematological malignancies Phase I/II (800) 283-8088 Nexavar® sorafenib Bayer HealthCare Pharmaceuticals Wayne, NJ thyroid cancer (see also breast, colorectal, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian) -------------------------------------------------neuroendocrine tumors Phase III (888) 842-2937 hematological malignancies Phase I/II www.gamida-cell.com NiCord® umbilical cord blood stem cell therapy Gamida Cell Jerusalem, Israel Medicines in Development Cancer 2012 ------------------------------------------Phase I (888) 842-2937 119 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status NTX-010 Neotropix Malvern, PA neuroendocrine tumors (see also lung) Phase I www.neotropix.com Opaxio™ paclitaxel poliglumex Cell Therapeutics Seattle, WA fallopian tube cancer, peritoneal cancer (see also brain, lung, ovarian, stomach) Phase III (800) 215-2355 OPR-003 EUSA Pharma Langhorne, PA Vaccinex Rochester, NY hematological malignancies Phase I (800) 833-3533 (585) 271-2700 OSI-906 (IGF-1R/1R tyrosinase kinase inhibitor) OSI Pharmaceuticals Farmingdale, NY adrenocortical carcinoma (see also lung, ovarian) Phase III (631) 962-0600 PEG arginine deiminase (ADI-PEG 20) Polaris Pharmaceuticals San Diego, CA pediatric cancer (see also liver, prostate, skin) Phase I (858) 452-6688 PF-04691502 (PI3K/mTOR inhibitor) Pfizer New York, NY endometrial cancer (see also solid tumors) Phase II (860) 732-5156 PF-05212384 (mTOR/PI3K inhibitor) Pfizer New York, NY endometrial cancer (see also solid tumors) Phase II (860) 732-5156 PHA848125 Nerviano Medical Services Nerviano, Italy thymoma Phase II www.nervianoms.com phenoxodiol Marshall Edwards San Diego, CA fallopian tube cancer (combination therapy) (see also ovarian, prostate) Phase I/II (858) 792-6300 PM-00104 PharmaMar Madrid, Spain endometrial cancer (see also cervical, sarcoma) Phase II www.pharmamar.com PTC299 PTC Therapeutics South Plainfield, NJ central nervous system (CNS) cancer in children (see also breast, solid tumors) Phase II (908) 222-7000 RG7112 (MDM2 antagonist) Roche Nutley, NJ hematological malignancies (see also solid tumors) Phase I (973) 235-5000 RG7388 (MDM2 inhibitor) Roche Nutley, NJ hematological malignancies (see also solid tumors) Phase I (973) 235-5000 RG7593 (mAb) Roche Nutley, NJ hematological malignancies Phase I (973) 235-5000 120 Medicines in Development Cancer 2012 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status RG7596 (antibody drug conjugate) Genentech South San Francisco, CA hematological malignancies Phase I (800) 626-3553 ridaforolimus ARIAD Pharmaceuticals Cambridge, MA Merck Whitehouse Station, NJ endometrial cancer (see also breast, kidney, lung, prostate, sarcoma) Phase II (800) 672-6372 rintatolimod Hemispherx Biopharma Philadelphia, PA cancer vaccine adjuvant Phase I/II (215) 988-0080 samarium SM-153 lexidronam injection EUSA Pharma Langhorne, PA bone metastases (see also breast, multiple myeloma, prostate, sarcoma) Phase III (800) 833-3533 SAR3419 (maytansin-loaded anti-CD19 mAb) Sanofi US Bridgewater, NJ ImmunoGen Needham, MA B-cell malignancies Phase II (800) 981-2491 (781) 895-0600 SAR245408 (XL147) (oral PI3K inhibitor) Sanofi US Bridgewater, NJ Exelixis South San Francisco, CA endometrial cancer (see also breast) Phase II (800) 981-2491 (650) 837-7000 SAR650984 (anti-CD38 naked mAb) Sanofi US Bridgewater, NJ hematological malignancies Phase I (800) 981-2491 SB989 (pracinostat) S*BIO Oakland, CA hematological malignancies (see also leukemia, solid tumors) Phase I (650) 730-2860 siltuximab Janssen Biotech Horsham, PA giant lymph node hyperplasia (see also multiple myeloma, prostate) Phase II (800) 526-7736 SOM230 (pasireotide) Novartis Pharmaceuticals East Hanover, NJ carcinoid tumors Phase III (888) 669-6682 ------------------------------------------Phase II (888) 669-6682 sotatercept (ACE-011) Celgene Summit, NJ cancer metastases (see also cancer-related) Phase II (908) 673-9000 SPRYCEL® dasatinib Bristol-Myers Squibb Princeton, NJ pediatric cancer (see also brain, breast, pancreatic, prostate) in clinical trials (800) 332-2056 Medicines in Development Cancer 2012 -------------------------------------------------meningioma, neuroendocrine tumors 121 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status StemEx® carlecortemcel-L (Orphan Drug) Gamida Cell Jerusalem, Israel Teva North America North Wales, PA hematological malignancies (Fast Track) Phase III (888) 838-2872 TAK-901 (aurora kinase B inhibitor) Millennium Pharmaceuticals Cambridge, MA hematological malignancies Phase I (800) 390-5663 Tarceva® erlotinib Genentech South San Francisco, CA OSI Pharmaceuticals Farmingdale, NY gynecological cancer (see also brain, breast, head/neck, leukemia, liver, lung) Phase II (800) 626-3553 (631) 962-0600 telapristone Repros Therapeutics The Woodlands, TX uterine leiomyoma Phase I/II (281) 719-3400 terameprocol Erimos Pharmaceuticals Houston, TX hematological malignancies (intravenous) (see also brain, cervical, head/neck, solid tumors) Phase I (713) 541-2000 TG02 S*BIO Oakland, CA Tragara Pharmaceuticals San Diego, CA hematological malignancies Phase I (650) 235-5539 (858) 350-6900 tivantinib (ARQ 197) ArQule Woburn, MA Daiichi Sankyo Parsippany, NJ germ cell and embryonal neoplasms (see also colorectal, kidney, liver, lung, pancreatic, sarcoma) Phase II (781) 994-0300 (973) 944-2600 TKI258 (dovitinib) Novartis Pharmaceuticals East Hanover, NJ second-line endometrial cancer, urothelial carcinoma (see also breast, kidney, multiple myeloma, prostate, skin) Phase II (888) 669-6682 TRC 105 (ENG protein inhibitor) TRACON Pharmaceuticals San Diego, CA fallopian tube cancer, peritoneal cancer (see also breast, ovarian, prostate) Phase II (858) 550-0780 trebananib (AMG386) Amgen Thousand Oaks, CA fallopian tube cancer, peritoneal cancer (see also breast, colorectal, kidney, liver, stomach) Phase III (800) 772-6436 122 Medicines in Development Cancer 2012 Medicines in Development for Cancer Other Cancers Product Name Sponsor Indication Development Status ulipristal Watson Pharmaceuticals Parsippany, NJ uterine leiomyoma Phase III (800) 900-1644 VB-111 VBL Therapeutics Or Yehuda, Israel thyroid cancer (see also brain) Phase I/II www.vblrx.com Velcade® bortezomib Millennium Pharmaceuticals Cambridge, MA adenocarcinoma (combination therapy) (see also leukemia, lymphoma, cancer-related) Phase II (800) 390-5663 volasertib Boehringer Ingelheim Pharmaceuticals Ridgefield, CT urogenital cancer Phase II (800) 243-0127 Votrient™ pazopanib GlaxoSmithKline Rsch. Triangle Park, NC fallopian tube cancer, peritoneal cancer (see also kidney, ovarian) Phase III (888) 825-5249 Xgeva™ denosumab Amgen Thousand Oaks, CA prevention of bone metastases in men with castrate-resistant prostate cancer (see also cancer-related, multiple myeloma) -------------------------------------------------prevention of bone metastases in women with early-stage breast cancer -------------------------------------------------giant cell tumor of bone application submitted (800) 772-6436 ------------------------------------------Phase III (800) 772-6436 ------------------------------------------Phase II (800) 772-6436 Zelboraf® vemurafenib Genentech South San Francisco, CA Plexxikon Berkeley, CA inoperable/unresectable thyroid cancer (see also brain, colorectal) Phase II (800) 626-3553 (510) 647-4000 Zolinza® vorinostat Merck Whitehouse Station, NJ gynecological cancer, peritoneal cancer (see also breast, leukemia, lung, lymphoma, multiple myeloma) Phase I/II (800) 672-6273 Medicines in Development Cancer 2012 123 Medicines in Development for Cancer Unspecified Cancer Product Name Sponsor Indication Development Status ABC294640 Apogee Biotechnology Hummelstown, PA late-stage disease Phase I (843) 792-3420 ABI-011 (nab®-5404) Celgene Summit, NJ Phase I (908) 673-9000 AFX-9901 Afecta Pharmaceuticals Irvine, CA in clinical trials (949) 253-4688 AGS-6MF Agensys Santa Monica, CA Astellas Pharma US Deerfield, IL Phase I (800) 695-4321 AGS-16M8F Agensys Santa Monica, CA Astellas Pharma US Deerfield, IL Phase I (800) 695-4321 ALT-836 Altor BioScience Miramar, FL Phase I/II (954) 443-8600 anti-KIR (BMS-986015) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 anti-LAG3 (BMS-986016) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 ANX-514 (docetaxel for injectable emulsion) ADVENTRX Pharmaceuticals San Diego, CA Phase I (858) 552-0866 ARRY-300 (MEK inhibitor) Array BioPharma Boulder, CO Novartis Pharmaceuticals East Hanover, NJ Phase I (877) 633-2436 (888) 669-6682 ARRY-382 (c-fms antagonist) Array BioPharma Boulder, CO Celgene Summit, NJ metastatic cancer Phase I (877) 633-2436 (908) 673-9000 AVL-292 (Btk inhibitor) Celgene Summit, NJ (see also leukemia, lymphoma) Phase I (908) 673-9000 B7-2/GM-CSF cancer gene therapy vaccine NuVax Therapeutics Tustin, CA BAY 94-9392 (PET imaging) Bayer HealthCare Pharmaceuticals Wayne, NJ 124 Phase I (714) 505-4461 cancer (diagnosis) Phase I (888) 842-2937 Medicines in Development Cancer 2012 Medicines in Development for Cancer Unspecified Cancer Product Name Sponsor cancer vaccine Immunitor USA Vancouver, Canada Phase I/II www.immunitor.com cancer vaccine (fibrocyte vaccine) Cytokine PharmaSciences King of Prussia, PA Phase I (610) 687-1776 carboxyamidotriazole orotate (CTO) Tactical Therapeutics New York, NY Phase I (212) 651-9653 CBLB502 Cleveland BioLabs Buffalo, NY Phase I (716) 849-6810 CDK 4/6 inhibitor (LY2835219) Eli Lilly Indianapolis, IN Phase II (800) 545-5979 CDX-301 (Fms-like tyrosine kinase 3 ligand) Celldex Therapeutics Needham, MA Phase I (781) 433-0771 cell therapy Cell Medica London, United Kingdom Center for Cell and Gene Therapy Houston, TX Phase II www.cellmedica.co.uk CEN-109 Centella Therapeutics Palo Alto, CA Chk1 inhibitor Eli Lilly Indianapolis, IN Phase I (800) 545-5979 c-Met inhibitor Eli Lilly Indianapolis, IN Phase I (800) 545-5979 c-Met mAb (LY2875358) Eli Lilly Indianapolis, IN Phase II (800) 545-5979 CSF-1R mAb (IMC-CS4) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ Phase I (800) 545-5979 curmucin Signpath Pharma Quakertown, PA Phase I (267) 772-0107 CXCR4 peptide inhibitor (LY2510924) Eli Lilly Indianapolis, IN Phase II (800) 545-5979 Medicines in Development Cancer 2012 Indication cancer (diagnosis) Development Status Phase II www.centellatx.com 125 Medicines in Development for Cancer Unspecified Cancer Product Name Sponsor cytotropic heterogeneous molecular lipids (CHML) Glory Pharmaceuticals Vienna, VA Phase I (703) 204-1703 DM-CHOC-PEN Dekk-Tec New Orleans, LA Phase I (504) 583-6135 EC0225 Endocyte West Lafayette, IN Phase I www.endocyte.com EGFR/IGFR tandem adnectin (BMS-964210) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 eIF-4E ASO (LY2275796) Eli Lilly Indianapolis, IN Phase II (800) 545-5979 fenretinide intravenous CerRx Lubbock, TX Phase I www.cerrx.com FGF receptor inhibitor Eli Lilly Indianapolis, IN Phase I (800) 545-5979 fluorapacin ACEA Biosciences San Diego, CA Phase I (866) 308-2232 gemcitabine prodrug Eli Lilly Indianapolis, IN Phase I (800) 545-5979 GI-6207 (cancer vaccine) GlobeImmune Louisville, CO Phase I (303) 625-2700 GSK3 inhibitor (LY2090314) Eli Lilly Indianapolis, IN Phase II (800) 545-5979 HBI-8000 HUYA Bioscience International San Diego, CA Quintiles Rsch. Triangle Park, NC Phase I www.huyabio.com hedgehog antagonist (LY2940680) Eli Lilly Indianapolis, IN Phase II (800) 545-5979 hTERT plasmid DNA cancer vaccine Merck Whitehouse Station, NJ Vical San Diego, CA Phase I (800) 672-6372 126 Indication Development Status Medicines in Development Cancer 2012 Medicines in Development for Cancer Unspecified Cancer Product Name Sponsor IL-21 (BMS-982470) Bristol-Myers Squibb Princeton, NJ In-111-DAC imaging agent Mayo Clinic Rochester, MN Naviscan San Diego, CA ISIS-STAT3Rx Isis Pharmaceuticals Carlsbad, CA Phase I (800) 679-4747 JAK2 inhibitor Eli Lilly Indianapolis, IN Phase I (800) 545-5979 masoprocol TriAct Therapeutics San Francisco, CA Phase II (415) 602-7497 MK-8033 (c-Met/RON protein inhibitor) Merck Whitehouse Station, NJ Phase I (800) 672-6372 new molecular entity Eli Lilly Indianapolis, IN Phase I (800) 545-5979 notch inhibitor Eli Lilly Indianapolis, IN Phase I (800) 545-5979 notch inhibitor (BMS-906024) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 OPB-31121 Otsuka America Pharmaceutical Rockville, MD Phase I (800) 562-3974 p38 MAP inhibitor (1) Eli Lilly Indianapolis, IN Phase I (800) 545-5979 p38 MAP inhibitor (2) Eli Lilly Indianapolis, IN Phase I (800) 545-5979 p70/AKT inhibitor Eli Lilly Indianapolis, IN Phase I (800) 545-5979 PB-357 Puma Biotechnology Los Angeles, CA Phase I (424) 248-6500 Medicines in Development Cancer 2012 Indication Development Status Phase I (800) 332-2056 cancer (diagnosis) Phase I www.mayoclinic.org 127 Medicines in Development for Cancer Unspecified Cancer Product Name Sponsor PBI-05204 Phoenix Biotechnology San Antonio, TX Phase I (210) 828-4373 PD-0325901 Pfizer New York, NY Phase I (860) 732-5156 PD-0332991 Pfizer New York, NY Phase II (860) 732-5156 PF-03084014 (gamma-secretase inhibitor) Pfizer New York, NY Phase I (860) 732-5156 PF-04449913 (sonic hedgehog pathway inhibitor) Pfizer New York, NY Phase I (860) 732-5156 PF-05082566 (CD137 antigen agonist mAb) Pfizer New York, NY Phase I (860) 732-5156 Proleukin® aldesleukin (subcutaneous) Prometheus Laboratories San Diego, CA Phase II (888) 892-8391 PRT6207 (Syk-specific inhibitor) Biogen Idec Cambridge, MA Portola Pharmaceuticals South San Francisco, CA Phase I (781) 464-2000 (650) 246-7000 RON mAb (IMC-RON8) Eli Lilly Indianapolis, IN ImClone Systems Bridgewater, NJ Phase I (800) 545-5979 SB1578 (JAK2 inhibitor) S*BIO Oakland, CA Phase I (650) 235-5539 SCH-900776 Merck Whitehouse Station, NJ Phase II (800) 672-6372 SMO antagonist (BMS-833923) Bristol-Myers Squibb Princeton, NJ Phase I (800) 332-2056 SR13668 SRI International Menlo Park, CA V930/V932 (plasmid DNA vaccine) Merck Whitehouse Station, NJ Vical San Diego, CA 128 Indication Development Status cancer (prevention) Phase 0 (650) 859-2000 Phase I (800) 672-6372 (858) 646-1100 Medicines in Development Cancer 2012 Medicines in Development for Cancer Unspecified Cancer Product Name Sponsor Indication Development Status VEGFR3 mAb (IMC-3C5) Eli Lilly Indianapolis, IN ImClone Bridgewater, NJ Phase I (800) 545-5979 XmAb® anti-cancer mAb Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Xencor Monrovia, CA Phase I (800) 243-0127 (626) 305-5900 The content of this report has been obtained through industry sources and the Adis “R&D Insight” database based on the latest information. Report current as of May 16, 2012. The information may not be comprehensive. For more specific information about a particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA’s web site. A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460 www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association. Copyright © 2012 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if proper credit is given. Pharmaceutical Research and Manufacturers of America • 950 F Street, NW, Washington, DC 20004 Medicines in Development Cancer 2012 129 Glossary actinic keratoses—Roughness and thickening of the skin caused by overexposure to the sun’s ultraviolet rays. It can degenerate into a skin cancer called squamous cell carcinoma. cutaneous—Pertaining to the skin. adenocarcinoma—Malignant tumor derived from a gland or glandular tissue. GIST—Gastrointestinal (GI) stromal cancer is an uncommon tumor of the GI tract. Not all GISTs are cancerous; some are benign. Although these cancers can arise anywhere in the GI tract, they occur most often in the stomach (60% to 70%) and less commonly in the small intestine (20% to 30%). The rest are found in the esophagus, large intestine, rectum, and anus. About 80% of people diagnosed with GIST are older than 50. It is slightly more common in men. Blacks are more likely to develop GISTs than whites. adjunctive treatment—An auxiliary treatment that is secondary to the main treatment. adjuvant—A substance or drug that aids another substance in its action. allogeneic—Refers to having cell types that are distinct and cause reactions in the immune system. application submitted—An application for marketing has been submitted by the company to the Food and Drug Administration (FDA). ascites—Excess fluid in the space between the tissues lining the abdomen and abdominal organs (the peritoneal cavity). basal cell cancer—Cancer of the lower layers of the skin. B-cell—A class of white blood cells important to the body’s immune system. biliary—Relating to bile. carcinoma—A malignant tumor that arises from epithelial tissues, such as skin. cervical—Relating to the neck of the uterus. chemoprotection—A therapeutic technique in which bone marrow cells are removed from an individual with cancer and are genetically modified to withstand higher doses of chemotherapy before being returned to the donor. cholangiocarcinoma—A malignancy of the biliary duct system that may originate in the liver and extrahepatic bile ducts. More than 90 percent are adenocarcinomas, and the remainder are squamous cell tumors. Cholangiocarcinomas tend to grow slowly and to infiltrate the walls of the ducts. Each year, approximately 2,500 cases occur, and the average incidence is 1 case per 100,000 people per year. 130 hepatocellular cancer/carcinoma—A cancer that begins in the liver cells. dysplasia—Abnormal tissue development. hyperuricemia—An abnormally high uric acid level in the blood. gastric—Of or relating to the stomach. glioblastoma—A fast growing and highly malignant type of brain tumor arising from glial (supporting) cells within the brain. There are about five to 10 new cases per million population per year in the United States. glioma—A type of brain tumor arising from the supporting glial cells within the brain. Gliomas make up about 60 percent of all primary brain tumors and are frequently malignant. graft-versus-host disease (GVHD)—A complication in bone marrow transplants where immune system cells attack the transplant recipient’s tissues. head and neck cancer—The term given to a variety of malignant tumors that develop in the mouth, throat, paranasal sinuses, nasal cavity, larynx, and salivary glands. Many authorities also include skin tumors of the face and neck and tumors of the cervical lymph nodes. There are more than half a million survivors of oral, head, and neck cancer living in the United States today. hematological malignancies—Cancers of the blood or blood-forming tissues, such as leukemia, Hodgkin’s and non-Hodgkin’s lymphomas, AIDS-related malignancies, multiple myeloma, myelodysplasia and myeloproliferative disorders. imaging agent—A substance used to enhance x-ray images of organs and spaces in the body. intraepithelial neoplasia, anal (AIN) & cervical (CIN)—AIN is a consequence of chronic human papillomavirus infection in the anal canal and appears to be driven by high viral loads of human papillomavirus. What is known of its natural history resembles that of cervical intraepithelial neoplasia. Dysplasia and cervical intraepithelial neoplasia (CIN) are different terms or names for the same condition—it is a precursor to cervical cancer. CIN may be mild, moderate or severe. Kaposi’s sarcoma—A rare, malignant skin tumor that occurs in some AIDS patients. It can be accompanied by fever, enlarged lymph nodes and gastrointestinal problems. Leiomyoma—A benign neoplasm derived from smooth muscle. leukemia—A form of cancer in which abnormally growing white blood cells are scattered throughout the body and bone marrow. They can take over the marrow and prevent it from making enough normal blood cells (white, red and platelets), leaving the patient highly susceptible to serious infections, anemia and bleeding episodes. The cells can also spill into the blood, infiltrating and interfering with the function of other organs. The four main types of leukemia are: acute lympho blastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), and chronic myeloid leukemia (CML). The acute types have a rapid onset, and overwhelming infection or blood loss can cause death. The chronic forms progress much more slowly. lung cancer—The leading cause of cancer deaths in both men and women. There are several types of lung cancer, the most common being squamous cell carcinoma, small (oat) cell carcinoma, adenocarcinoma and large cell Medicines in Development Cancer 2012 Glossary carcinoma. Each has a different growth pattern and response to treatment. The squamous cell, small cell and large cell types are all strongly associated with tobacco abuse. lymphoma—Cancers in which the cells of lymphoid tissue, found mainly in the lymph nodes and spleen, multiply unchecked. Lymphomas fall into two categories: Hodgkin disease, characterized by a particular kind of abnormal cell, and non-Hodgkin lymphomas, which vary in their malignancy according to the nature and activity of the abnormal cells. Mantle cell lymphoma is a type of non-Hodgkin lymphoma. macroglobulinemia—A disorder in which plasma cells produce an excessive quantity of macroglobulins (large antibodies) that accumulate in the blood. It results from a group of abnormal, cancerous lymphocytes and plasma cells. Men are affected more often than women, and the average age at onset is 65. mastocytosis—A condition characterized by infiltration of mast cells into the tissues of the body. Mast cells are connective tissue cells which release chemicals including histamine that are very irritating and cause itching, swelling, and fluid leakage from cells. medullary—Relating to the medulla (any soft marrow-like structure, especially the innermost part) or marrow. melanoma—A cancer made up of pigmented (usually brown-colored) skin cells anywhere in the body. multiple myeloma—A malignant condition of middle to old age, characterized by the uncontrolled proliferation and disordered function of plasma cells in the bone marrow. The condition, which makes the patient particularly prone to infection, is rare, with about three new cases annually per 100,000 population. myeloablation—A severe form of myelosuppression, a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets. It is a side effect of some cancer treatments. myelodysplastic syndromes (MDS)—Blood disorders that ultimately are fatal. Patients usually succumb to infections or bleeding. The term “preleukemia” has been used to describe these disorders. neoadjuvant therapy—Chemotherapy, radiation therapy, or hormone therapy given before the primary or main treatment. Neo-adjuvant therapy, like chemotherapy and radiation therapy, is often given before surgery to reduce the size of a tumor or to make surgery less complicated. neuroblastoma—A tumor of the adrenal glands or sympathetic nervous system (the part of the nervous system responsible for certain automatic body functions, such as the control of heart rate). Neuroblastomas are the most common extracranial (outside the skull) solid tumors of childhood. mesothelioma—A tumor of the lining of the lung and chest cavity (the pleura). osteosarcoma—Cancer of the bone that occurs predominantly in adolescents and young adults. It accounts for 5 percent of cancer in children. metastases/metastatic—Areas of secondary cancer that have spread from the primary or original cancer site. peritoneal—Relating to the peritoneum, the membrane that lines the abdominal cavity and covers most of the abdominal organs. mucositis—The swelling, irritation, and ulceration of the mucosal cells that line the digestive tract. Mucositis can occur anywhere along the digestive tract from the mouth to the anus. It can be a very troublesome and painful side effect of chemotherapy. Phase 0—First-in-human trials conducted in accordance with FDA’s 2006 guidance on exploratory Investigational New Drug (IND) studies designed to speed up development of promising drugs by establishing very early on whether the agent behaves in human subjects as was anticipated from preclinical studies. Medicines in Development Cancer 2012 Phase I—Safety testing and pharmacological profiling of new drugs in small numbers of humans. Phase II—Effectiveness testing and identification of side effects of new drugs in humans. Phase III—Extensive clinical trials in humans to verify effectiveness and monitor adverse reactions of new drugs. prolactinoma—A noncancerous pituitary tumor that produces a hormone called prolactin, which results in too much prolactin in the blood. refractory—Resistant to treatment or cure. sarcoma—A malignant tumor that arises from deep body tissues, such as muscle, bone or fibrous tissue. T-cell—One of two main classes of white blood cells called lymphocytes, which are important to the body’s disease-fighting immune system. thrombocytopenia—A reduction in the number of platelet cells in the blood, which causes a tendency to bleed, especially from the smaller blood vessels. thymoma—Although rare, thymomas are the most common tumor of the thymus, a small organ located in the upper chest just below the neck that produces certain types of white blood cells (lymphocytes) before birth and during childhood. Thymomas arise from thymic epithelial cells, which make up the covering of the thymus. Up to 40 percent of thymomas are invasive. They affect men and women equally and are usually diagnosed between the ages of 40 and 60. Thymomas are uncommon in children. unresectable—Unable to be removed (resected) by surgery. 131 Selected Facts about Cancer in the United States Overview1 • Cancer is the second leading cause of death by disease—nearly 1 of every 4 deaths—in the United States, exceeded only by heart disease. •Men have slightly less than a 1 in 2 lifetime risk of developing cancer; for women, the risk is a little more than 1 in 3. About 77 percent of all cancers are diagnosed in people ages 55 and older. •This year alone, more than 1.6 million new cancer cases are expected to be diagnosed, and an estimated 577,190 people are expected to die of cancer. That’s more than 1,500 people a day. •Scientific evidence suggests that about one-third of the cancer deaths expected this year will be related to overweight or obesity, physical inactivity, and poor nutrition, and thus could be prevented. •The National Cancer Institute estimates that nearly 12 million Americans with a history of cancer were alive in January 2008. The 5-year relative survival rate for all cancers diagnosed between 2001 and 2007 is 67 percent, up from 49 percent in the mid-70s. Costs1 •The National Institutes of Health estimates overall costs for cancer in 2007 at $226.8 billion: $103.8 billion for direct medical costs (total of all health expenditures) and $123 billion for indirect mortality costs (cost of lost productivity due to premature death). Pain •Studies have shown that pain occurs in 30 percent of all cancer patients, regardless of the stage of the disease, and 90 percent of patients with advanced cancer experience severe pain. Half of patients may be undertreated for cancer pain.2 •The most common cause of cancer-related pain is from metastases to the bone. Up to 80 percent of cancer patients with bone metastases experience pain. The second most common cause of cancer pain is related to tumors infiltrating the nerve and hollow viscus. Tumors near neural structures may cause the most severe pain. The third most common cause of pain associated with cancer result from chemotherapy, radiation, or surgery.2 •Breakthrough pain—pain that occurs even when taking regular pain medication—is common in cancer patients. Breakthrough cancer pain occurs in 50 percent to 90 percent of oncology inpatient settings, 89 percent of home care and inpatient hospice settings, and 35 percent of community-based oncology practices. People with breakthrough pain have a significantly higher rate of hospitalization than those without breakthrough pain (36.9 percent vs. 22.5 percent, respectively) and dramatically higher estimated annual costs of care ($1.7 million compared with $192,000).3 132 Medicines in Development Cancer 2012 Selected Facts about Cancer in the United States New Cancer Cases/Deaths1 Cancer Type Estimated 2012 New Cases Estimated 2012 Deaths All Sites ................................................................................... 1,638,910...................................................................................... 577,190 Male.............................................................................. 848,170...................................................................................... 301,820 Female.......................................................................... 790,740...................................................................................... 275,370 Acute Lymphocytic Leukemia........................................................... 6,050.......................................................................................... 1,440 Male.................................................................................. 3,450............................................................................................. 820 Female.............................................................................. 2,600............................................................................................. 620 Acute Myeloid Leukemia................................................................ 13,780........................................................................................ 10,200 Male.................................................................................. 7,350.......................................................................................... 5,790 Female.............................................................................. 6,430.......................................................................................... 4,410 Bladder Cancer............................................................................... 73,510........................................................................................ 14,880 Male................................................................................ 55,600........................................................................................ 10,510 Female............................................................................ 17,910.......................................................................................... 4,370 Bone Cancer (and joints).................................................................. 2,890.......................................................................................... 1,410 Male.................................................................................. 1,600............................................................................................. 790 Female.............................................................................. 1,290............................................................................................. 620 Brain Cancer (and other nervous system)...................................... 22,910........................................................................................ 13,700 Male................................................................................ 12,630.......................................................................................... 7,720 Female............................................................................ 10,280.......................................................................................... 5,980 Breast Cancer............................................................................... 229,060........................................................................................ 39,920 Male.................................................................................. 2,190............................................................................................. 410 Female.......................................................................... 226,870........................................................................................ 39,510 Cervical and Uterine Cancers......................................................... 59,300........................................................................................ 12,230 Male........................................................................................—................................................................................................— Female............................................................................ 59,300........................................................................................ 12,230 Chronic Lymphocytic Leukemia...................................................... 16,060.......................................................................................... 4,580 Male.................................................................................. 9,490.......................................................................................... 2,730 Female.............................................................................. 6,570.......................................................................................... 1,850 Chronic Myeloid Leukemia............................................................... 5,430............................................................................................. 610 Male.................................................................................. 3,210............................................................................................. 370 Female.............................................................................. 2,220............................................................................................. 240 Colorectal Cancer......................................................................... 143,460........................................................................................ 51,690 Male................................................................................ 73,420........................................................................................ 26,470 Female............................................................................ 70,040........................................................................................ 25,220 Medicines in Development Cancer 2012 133 Selected Facts about Cancer in the United States New Cancer Cases/Deaths1 continued Cancer Type Estimated 2012 New Cases Estimated 2012 Deaths Esophageal Cancer........................................................................ 17,460........................................................................................ 15,070 Male................................................................................ 13,950........................................................................................ 12,040 Female.............................................................................. 3,510.......................................................................................... 3,030 Kidney Cancer (and renal pelvis)................................................... 64,770........................................................................................ 13,570 Male................................................................................ 40,250.......................................................................................... 8,650 Female............................................................................ 24,520.......................................................................................... 4,920 Leukemia (all types)....................................................................... 47,150........................................................................................ 23,540 Male................................................................................ 26,830........................................................................................ 13,500 Female............................................................................ 20,320........................................................................................ 10,040 Liver Cancer................................................................................... 28,720........................................................................................ 20,550 Male................................................................................ 21,370........................................................................................ 13,980 Female.............................................................................. 7,350.......................................................................................... 6,570 Lung Cancer (and bronchus)........................................................ 226,160...................................................................................... 160,340 Male...............................................................................116,470........................................................................................ 87,750 Female.......................................................................... 109,690........................................................................................ 72,590 Lymphoma (all types)..................................................................... 79,190........................................................................................ 20,130 Male................................................................................ 43,120........................................................................................ 10,990 Female............................................................................ 36,070.......................................................................................... 9,140 Lymphoma (non-Hodgkin’s)............................................................ 70,130........................................................................................ 18,940 Male................................................................................ 38,160........................................................................................ 10,320 Female............................................................................ 31,970.......................................................................................... 8,620 Melanoma-Skin Cancer.................................................................. 76,250.......................................................................................... 9,180 Male................................................................................ 44,250.......................................................................................... 6,060 Female............................................................................ 32,000.......................................................................................... 3,120 Multiple Myeloma............................................................................ 21,700........................................................................................ 10,710 Male................................................................................ 12,190.......................................................................................... 6,020 Female.............................................................................. 9,510.......................................................................................... 4,690 Ovarian Cancer.............................................................................. 22,280........................................................................................ 15,500 Male........................................................................................—................................................................................................— Female............................................................................ 22,280........................................................................................ 15,500 Pancreatic Cancer.......................................................................... 43,920........................................................................................ 37,390 Male................................................................................ 22,090........................................................................................ 18,850 Female............................................................................ 21,830........................................................................................ 18,540 134 Medicines in Development Cancer 2012 Selected Facts about Cancer in the United States New Cancer Cases/Deaths1 continued Cancer Type Estimated 2012 New Cases Estimated 2012 Deaths Prostate Cancer............................................................................ 241,740........................................................................................ 28,170 Male.............................................................................. 241,740........................................................................................ 28,170 Female....................................................................................—................................................................................................— Stomach Cancer............................................................................. 21,320........................................................................................ 10,540 Male................................................................................ 13,020.......................................................................................... 6,190 Female.............................................................................. 8,300.......................................................................................... 4,350 Sources: 1. Cancer Facts & Figures 2012, American Cancer Society (www.cancer.org) 2. Remedy Health Media, LLC (www.healthcommunities.com) 3. American Pain Foundation (www.painfoundation.org) Medicines in Development Cancer 2012 135 The Drug Discovery, Development and Approval Process Developing a new medicine takes an average of 10-15 years; For every 5,000-10,000 compounds in the pipeline, only 1 is approved. The Drug Development and Approval Process The U.S. system of new drug approvals is perhaps the most rigorous in the world. It takes 10-15 years, on average, for an experimental drug to travel from lab to U.S. patients, according to the Tufts Center for the Study of Drug Development. Only five in 5,000 compounds that enter preclinical testing make it to human testing. And only one of those five is approved for sale. On average, it costs a company $1.2 billion, including the cost of failures, to get one new medicine from the laboratory to U.S. patients, according to a 2007 study by the Tufts Center for the Study of Drug Development. Once a new compound has been identified in the laboratory, medicines are usually developed as follows: Preclinical Testing. A pharmaceutical company conducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the compound is evaluated for safety. Investigational New Drug Application (IND). After completing preclinical testing, a company files an IND with the U.S. Food and Drug Administration (FDA) to begin to test the drug in people. The IND shows results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical trials must be reviewed and approved by the Institutional Review Board (IRB) where the trials will be conducted. Progress reports on clinical trials must be submitted at least annually to FDA and the IRB. Clinical Trials, Phase I. These tests usually involve about 20 to 100 healthy volunteers. The tests study a drug’s safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabolized, and excreted as well as the duration of its action. Clinical Trials, Phase II. In this phase, controlled trials of approximately 100 to 500 volunteer patients (people with the disease) assess a drug’s effectiveness and determine the early side effect profile. Clinical Trials, Phase III. This phase usually involves 1,000 to 5,000 patients in clinics and hospitals. Physicians monitor patients closely to confirm efficacy and identify adverse events. New Drug Application (NDA)/Biologic License Application (BLA). Following the completion of all three phases of clinical trials, a company analyzes all of the data and files an NDA or BLA with FDA if the data successfully demonstrate both safety and effectiveness. The applications contain all of the scientific information that the company has gathered. Applications typically run 100,000 pages or more. Approval. Once FDA approves an NDA or BLA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines, FDA requires additional trials (Phase IV) to evaluate long-term effects. Discovering and developing safe and effective new medicines is a long, difficult, and expensive process. PhRMA member companies invested an estimated $49.5 billion in research and development in 2011.