PC Detect - Panacea Global, Inc
Transcription
PC Detect - Panacea Global, Inc
P G Cancer Detection Services P C D e t e c t SM A new and sensitive diagnostic test for the detection of prostate cancer. Please Contact Dr. Mahmood Moshiri President/CEO 330 Highway 7 East Suite 502 Richmond Hill ON Canada L4B 3P8 P: 905-881-1049 F: 905-881-2241 www.panaceaglobalinc.com Cancer Detection Services PC Detect® Cancer as a disease is one of the world's worst public health and financial problems. Statistics from the American Cancer Society for 2004 indicate that an estimated 1.4 million people were diagnosed with cancer in the U.S. and 564,000 people or about 1,500 people a day, are expected to die of cancer this year in the U.S. alone. Cancer Diagnostics—HAAH also has great potential to serve as a biomarker for cancer diagnosis and monitoring as well as in treatment follow-up. Again the specificity of HAAH overexpression for cancer and its presence in a broad spectrum of cancer types are highly significant and beneficial for its utility as a tumor marker. Panacea has developed methods to determine HAAH levels at both the gene expression (mRNA) and protein expression levels. HAAH can enhance the detection of cancer in tissue biopsies and can be prognostic for disease severity. Methods have been developed at the Company to stain human tissues with antiHAAH antibodies, identifying the presence of cancer cells in the tissue sample. In one study utilizing this methodology, HAAH protein expression was identified in resected tissue from individuals with cholangiocarcinoma. Significantly, the levels of HAAH expression in this resected tissue directly correlated with patient survival time, indicating that HAAH expression level measured in this fashion may be useful in determining a patient’s prognosis and in tailoring therapy accordingly. HAAH expression is upregulated at the gene expression level in cancer and this increased expression may serve as the basis for a highly sensitive test for diagnosis and monitoring of disease as well as the measurement of drug efficacy. The Company has developed a highly sensitive qRT-PCR molecular diagnostic test to measure the expression of HAAH at the mRNA level. This test is capable of detecting one cancer cell in a background of 50,000 normal cells and thus has potential application for the measurement of minimal residual disease in various blood cancers (e.g. acute myeloid leukemia). Furthermore, the Company has demonstrated that HAAH over expression is itself regulated in certain cancers by signaling pathways that are downstream of tyrosine kinase activities. Tyrosine kinase inhibitors (e.g. Gleevec, Sutent, Nexavar and Tarceva) have emerged as potent anti-cancer agents. However, many of these drugs are only efficacious in a subset of cancers and in a number of cases patients develop resistance to these drugs. As such a mechanism by which one can determine the potential efficacy of a tyrosine kinase inhibitor in an individual patient prior to its use is highly desired. Panacea has developed just such a test by monitoring the expression of HAAH upon treatment of a patient’s cells in vitro with the drug. An efficacious drug leads to a down-regulation of HAAH expression. HAAH is found in the serum of cancer patients and is a biomarker for disease. The Company has demonstrated that the HAAH protein is shed in the blood through an as-yet poorly understood mechanism. The presence of HAAH in an individual’s serum has been shown to correlate with the presence of cancer. Panacea has developed a simple assay to monitor HAAH levels in patient sera. This assay has broad application for screening of individuals for initial detection as well as recurrence of many different kinds of cancers including some for which currently no other biomarker exists. Anti-HAAH antibodies may hold significant potential for in vivo imaging of tumors. The localization of HAAH to the cellular surface of tumor cells and its consequent accessibility to antibodies suggests its potential for use as target for imaging enhancing agents. Radio-labeling of anti-HAAH antibodies and their incorporation into various radiological tests may provide significant advantages for the localization of tumor masses and the identification of micro-metastases. Anti-HAAH antibodies may also hold significant potential for identification and isolation of circulating cancer cells. The detection of circulating tumor cells has been proposed as a method to assess response to treatment of metastatic breast cancer. The detection of tumor cells may also have clinical utility in risk stratification in early breast cancer, in early detection of relapse and in monitoring the response to treatment. The presence of circulating tumor cells in patients with metastatic carcinoma is associated with short survival. Technical advances have facilitated the detection of rare circulating tumor cells. These cells appear to have characteristics of tumor cells and may be identified in the peripheral blood of patients with cancer. The techniques have been used to detect circulating tumor cells include cytometric and nucleic acid based approaches. The cytometric 1 PC Detect® Cancer Detection Services approaches use HAAH Over-Expression in Cancer by IHC immunocytochemical methods to identify and HAAH has been detected in all characterize the individual cancer types tested (n>20) including: liver, bile duct, lung, tumor cells. Nucleic acid breast, prostate, colon, ovary, based approaches detect pancreas and in nearly 100% of the DNA and RNA all cancer specimens (n>1,000) sequences that are differentially expressed in HAAH was not detected in over tumor cells and normal 500 non-cancerous tissues including proliferative disorders blood components. A kit currently marketed by Staining for HAAH is found Johnson & Johnson throughout the cancerous tissue involves a technique of but is generally more prominent Cancerous and Normal Bile Duct mixing a blood sample at the infiltrating margins of the with iron particles coated tumor with an antibody that Expression of HAAH can be attaches to epithelial cells. detected at both the genetic and The epithelial cells are protein levels then distinguished from leukocytes by antibodies that have been tagged with a fluorescent dye so that the cancer cells can be easily distinguished and counted. Since epithelial cells are not usually found in the blood, these cells are likely cancerous cells from the breast tumor. This technique has been shown to distinguish carcinoma cells from other blood cells, and recovery of the breast carcinoma cells is 75–100 percent. Another system is an enhanced density gradient system that combines density gradient centrifugation and the immunobased techniques. This system is not approved by the U.S. FDA and is available only for research purposes. Anti-HAAH antibodies may have utility in systems and kits to identify and isolate a broad range of circulating tumor cells. Leukemia Lung Carcinoma Breast Cancer Pancreatic Cancer Cholangiocarcinoma Normal Bile Duct Proliferating Sclerosing Cholangitis (PSC) Confidential Panacea Laboratories was established in 2006 to provide blood, serum, and tissue tests to diagnose and monitor cancer. The facilities are fully compliant with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA established quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the U.S. Centers for Medicare & Medicaid Services and obtain CLIA certification. CLIA-certified laboratories are required to have documented standard operating procedures (SOPs), and procedures for sample receiving and handling, result reporting, confidentiality, billing and training of technical staff. CLIA specifies quality standards for proficiency testing, patient test management, quality control, personnel and quality assurance. Three categories of tests have been established: waived complexity, moderate complexity, including the subcategory of provider-performed microscopy, and high complexity. Tests performed by a CLIAcertified laboratory, such as those performed by Panacea Laboratories, do not require prior approval by the U.S. FDA. To date, marketing and promotion of tests performed by Panacea Laboratories has been conducted primarily through attendance and exhibiting at scientific and clinical meetings relevant to oncologists and urologists. A dedicated website (www.panacea-labs.com) has been established to provide information to both physicians and consumers concerning tests performed by Panacea Laboratories. Beginning in mid-2007, efforts were initiated to establish partnerships with local laboratories around the U.S. to collect patient samples for shipment to Panacea, where testing will be performed. Results will be reported to the ordering physicians upon completion of testing. These local laboratories will 2 PC Detect® Cancer Detection Services also be responsible for marketing of Panacea’s tests to local physicians. Similar partnerships are also being pursued with laboratories outside the U.S. ® PC Detect is an ELISA assay measuring serum levels of HAAH to help determine the likelihood ® that a patient has prostate cancer. PC Detect is recommended for men who have an elevated prostate specific antigen Serum HAAH Concentration in Prostate Cancer (PSA) and/or an abnormal digital rectal exam (DRE). 130 ® ® from PC Detect should be interpreted in conjunction with the patient's PSA level, DRE, and medical and family history. Prostate biopsy is necessary for a definitive diagnosis of cancer. The excellent sensitivity and ® specificity of PC Detect across a range of PSA levels has been demonstrated using samples from 233 men with biopsy-proven prostate cancer. 110 90 70 HAAH PC Detect provides information to differentiate prostate cancer from benign conditions and to help guide patient management. Low levels of HAAH as seen in normal men may obviate the need for biopsy. The results 50 30 10 -10 Non-Cancer* PSA <2 PSA 2-4 PSA >4 n = 43 x =0 n = 100 x = 23.0 n = 49 x = 21.1 n = 84 x = 31.60 Prostate Cancer n = 233, x = 25.7 Specificity = 93% Sensitivity = 95% * Men >50 years of age, cancer-free ® PC Detect is currently available from Panacea Laboratories. In addition, Panacea is seeking FDA approval of this test to permit wider marketing and use in the U.S. A prospective, multi-center clinical ® trial to evaluate the diagnostic performance of PC Detect for prostate cancer screening in 600 men recommended to undergo prostate biopsy was fully enrolled earlier this year. Data from this clinical trial will be submitted in early 2008 as part of a PreMarket Approval (PMA) application to the U.S. FDA, to facilitate development of a diagnostic kit and subsequent marketing to laboratories across the ® U.S. Panacea anticipates completion of an out-licensing deal for development of a PC Detect kit ® with one or more large manufacturers of diagnostic tests in 2008. PC Detect is indicated for the measurement of serum HAAH levels in conjunction with the quantitative measurement of PSA and a DRE, as an aid in the detection of early prostate cancer in men aged 50 years and older. The American Cancer Society (ACS) recommends a PSA blood test and DRE yearly, beginning at age 50, for men who have at least a 10-year life expectancy. Men at high risk, such as African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65), should begin testing at age 45. Men at even higher risk (because they have several first-degree relatives who had prostate cancer at an early age) are recommended to begin testing at age 40. Depending on the results of this initial test, further testing might not be needed until age 45. The American Urological Association (AUA) endorses the screening parameters of the ACS, including the fact that men with risk factors should be offered testing at an earlier age. In current clinical practice, prostate biopsy is recommended for men with a suspicious DRE result regardless of the PSA level. According to the ACS, patients with a PSA > 10ng/mL are also recommended to have a biopsy since more than 50 percent of these men have been found to have 3 PC Detect® Cancer Detection Services biopsies positive for cancer. A biopsy may be recommended for a non-suspicious DRE result and a PSA result of between 4-10ng/mL as 25 percent of these men will also be positive for prostate cancer. A recent study analyzing the prevalence of prostate cancer in patients with PSA levels below 4.0 ng/ml found significant detection rates of 6.6 percent (<0.5 ng/ml), 10.1 percent (0.6-1.0 ng/ml), 17.0 percent (1.1–2.0 ng/ml), 23.9 percent (2.1-3.0 ng/ml) and 26.9 percent (3.1-4.0 ng/ml). Approximately 20 percent of prostate cancers with aggressive features are found in men whose PSA level is less than 4 ng/ml. On the basis of these and other recent studies, it has now been suggested to consider biopsy in patients with a PSA level as low as 2.5 ng/ml. The PSA level can be used as a guide in clinical practice but has limitations. As noted in the observations cited, even though a significant percentage of men with prostate cancer had PSA levels below 4.0 ng/ml, the negative biopsy rate of more than 70 percent indicates that PSA is lacking in terms of specificity and sensitivity, thus making it an unreliable tool as a tumor marker. As well, high levels of PSA are common in benign conditions of the prostate. The DRE is also used as an assessment of abnormalities in the prostate and is performed to further assess the patient for possible voiding dysfunction as well as to detect possible cancer. A suspicious area palpated during the examination usually leads to a recommendation for a biopsy in order to establish a more definitive diagnosis. ® PC Detect used in conjunction with PSA and DRE has the potential to improve the specificity of prostate cancer screening tests and thus reduce the number of men undergoing unnecessary biopsy, which will result in reducing potential patient morbidity as well as achieving health care cost savings. A positive test result may be due to other cancers or occasionally may have unknown causes. Patients who have very small foci of cancer in their prostates ,may have serum HAAH levels in the normal range. In such cases, physicians may recommend “watchful waiting” rather than immediate ® treatment and may find it useful to monitor the patient’s cancer with frequent repeat PC Detect testing. ® Panacea Laboratories developed PC Detect and has determined its analytical performance characteristics. Panacea Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing such as this immunoassay. HAAH function is consistent with cancer etiology. HAAH is an enzyme that catalyzes the βhydroxylation of aspartyl or asparaginyl residues in EGF-like domains found in a number of proteins involved in important cellular signaling pathways as well as in several proteins that interact with the extracellular matrix. Both of these types of proteins have been demonstrated to play important roles in the development and maintenance of the cancer cell and this subtle modification due to HAAH activity can have profound effects on protein function. One important example is the Notch signaling pathway which is known to affect cell fate decisions and growth control during cellular maturation. Notch has 17 EGF-like domains and is involved in cancer phenotypes such as proliferation, motility and invasiveness effecting tumor growth and metastatic potential. A direct interaction between Notch and HAAH has been demonstrated in tumor cells. HAAH has been demonstrated to be sufficient to induce a cancer cell phenotype. When over expression of the HAAH gene is induced in otherwise normal cells, these cells become cancerous as judged by their phenotypic properties in vitro. Specifically the transformed cells have increased rates of proliferation, loss of contact inhibition and enhanced motility and invasiveness. More importantly these transformed cells form solid tumors when injected into animals. Conversely, when cancer cells are treated to inhibit HAAH over-expression, the cancer cells revert to a normal phenotype as measured by these same standard criteria. HAAH is over-expressed specifically by tumor cells and is not required for normal cell function. Although initially identified in liver cancer, increased expression of cell-surface HAAH has been observed in more than twenty different cancers, including both solid tumors and blood cancers. 4 Cancer Detection Services PC Detect ® The over-expression of HAAH is not associated with any normal tissues in children and adults with the exception of placental trophoblastic tissue where HAAH is thought to be involved in implantation in the uterine wall. HAAH is important for the maintenance of the tumor cell phenotype, as described above, but not required for normal cellular function. This is evidenced by the creation of transgenic mice in which the murine equivalent of the HAAH gene was “knocked-out” such that the animals did not express HAAH. These animals were “normal” except for two features; they had several physical developmental deficits (e.g. shortened snout, palate defects and fused digits) and they displayed reduced levels of fertility. Interestingly, this phenotype is consistent with the effects of knock-out mutations of Notch in mice. Importantly, these developmental abnormalities are not relevant to treatment of already developed mice (or people.) HAAH is expressed on the surface of cancer cells. In normal cells, HAAH is generally expressed at very low levels exclusively in the endoplasmic reticulum (ER) of the cell. Thus the protein is only found within the cell. In tumor cells, HAAH over-expression leads to a translocation of the protein from the internal compartment of the ER to the cellular surface. This translocation results in the approximation of HAAH to its potential substrates such as Notch, a cell surface receptor, and tenascin, a component of the extra-cellular matrix. Surface expression of HAAH also makes it accessible to drugs or antibodies that are not capable of crossing cellular membranes. Thus, several unique attributes of HAAH make it an extremely promising anti-cancer therapeutic target: HAAH plays an important role in the promotion, proliferation, motility, invasiveness and metastasis of tumors. Therefore targeting the HAAH protein is likely to have a direct effect on the very processes that characterize malignancy. Increased expression of HAAH is specific to tumor cells and the enzyme is not necessary for normal cell function. Thus, targeting HAAH will decrease only tumor cell function and should not cause any adverse effects in normal tissues. HAAH over-expression has been observed in more than twenty different cancers. This feature suggests that anti-HAAH therapy which is developed for a single cancer type, will be effective in other types of cancer HAAH is expressed on the surface of cancer cells making it accessible from outside the cell. This attribute opens up the potential for the use of anti-HAAH antibodies as therapeutic agents. Antibodies that do not cross cellular membranes, but interact with membrane proteins, have demonstrated great potential as druggable agents in oncology and other disease states. Current Collaborations—Panacea has several corporate and academic collaborations with the aim of advancing specific products toward commercialization and exploring new uses for current technologies. These collaborations involve the provision of grant or contract support by Panacea to collaborators, as well as support by collaborators provided to Panacea; the collaboration with MDS Pharma Services, Inc. is totally supported by external grant funding provided to Panacea. In addition, Panacea has obtained exclusive licenses to certain therapeutic, diagnostic and manufacturing technologies from highly regarded academic collaborators. Product/Technology HAAH HAAH Collaborator Brown University/Rhode Island Hospital Massachusetts Institute of Technology HAAH Catalent (formerly the Gala Biosciences Division, Cardinal Health) HAAH Olympus Focus Exclusive world-wide license and collaboration for therapeutic and diagnostic applications Exclusive license option and collaboration to develop human anti-HAAH monoclonal antibodies Scale-up, process development, and GMP production of anti-HAAH monoclonal antibody therapeutic Development of HAAH-based ELISA assay for cancer diagnostics tests 5 Cancer Detection Services PC Detect® Management and Board of Advisors Mahmood Moshiri BS, MD, CPATH, APATH, FICN President, Chief Executive Officer and Chief Medical Officer Since 1990, Dr. Moshiri has been on faculty at several medical universities. Dr Moshiri has extensive experience in teaching and practicing medicine and performing clinical research focused on preventive medicine, cardiovascular health and cancer pathology. He has published extensively on the subject of pathology in preventive and therapeutic disciplines during the last 20 years. Dr. Moshiri has hosted numerous newscasts in the health and preventive fields for National TV. In addition to his media expertise, his articles have been published in many American, European and Asian medical journals. He has been a contributing author of medical books published in North America. Dr. Moshiri has participated in numerous national and international conferences as an organizer, session chair, panelist, invited lecturer and international speaker in many world Medical Congresses. Dr. Moshiri served as Vice President of the International College of Nutrition and has received three Medical World Congress Awards (1997 Banff, 2007 Alberta, and 2010 Egypt). Dr. Moshiri is an editorial board member of The Open Neutriceutical Journal (USA) and he is also a member of the Board of Directors for Panacea Laboratories Canada Inc., Proteus Imaging Canada Inc. , and Panacea Global Inc. , and Vice President of Panacea Pharmaceutical, Inc. Dr. Moshiri is BS, MD, Pathologist. Binnay Sethi Vice President Binnay Sethi is the Secretary and Director of Panacea Global, Inc. He is also the CEO of Binalli Vision, one of the largest building maintenance companies in Canada. Binalli Vision has over 500 clients and employs over 400 people. He founded the company in 1995 and has grown the organization from inception. Throughout his career, Mr. Sethi has founded and managed numerous companies that deal with building maintenance and real property administration. Mr. Sethi studied Business and International business at York University and Seneca College. Panacea Global is currently in the process of hiring an independent Board of Directors who will execute the strategic plan of the company. Hossein A. Ghanbari, Ph.D. Dr. Ghanbari co-founded Panacea Pharmaceuticals, Inc. and serves as Chairman, CEO & Chief Scientific Officer. Dr. Ghanbari worked at the world headquarters of Abbott Laboratories in Chicago, Illinois for more than ten years, where he developed several pharmaceuticals and the first diagnostic test for Alzheimer’s Disease test marketed in the world. He served on Abbott’s Technical Advisory Board and was inducted into its Volwiler Society, a prestigious honorary organization that serves as Abbott’s recognition of the highest standards of scientific accomplishment. Prior to that, he was a co-founder and served as Senior Vice-President for Research & Development of Molecular Geriatrics Corporation, a bio-pharmaceutical company that focused on developing drugs for neurodegenerative diseases. He was also the Founder, CEO, & President of Medical Toolworks, which was created to develop highly needed and innovative medical tools. Dr. Ghanbari served as Senior Vice-President for Research & Development and Strategic Planning as well as Director for four years at Nymox Pharmaceutical Corporation. He was instrumental in starting Nymox (NASDAQ: NYMX), and was responsible for bringing in an array of technologies which have established Nymox as an international presence in the area of Alzheimer’s diagnostics and therapeutics. Dr. Ghanbari is the current Chairman of the Board of Alzheimer’s Corporation of Albuquerque, New Mexico. Professor Jack R. Wands, M.D. Professor Jack R. Wands, M.D. is a Senior Consultant to the Company and Panacea Pharmaceuticals collaborator at Rhode Island Hospital/Brown University. He is a highly respected and internationally recognized scientist with more than 400 scientific publications, books, and abstracts. Dr. Wands is currently Chief of the Division of Gastroenterology at Lifespan Rhode Island Academic Medical Center, Director of the Liver Research Center, Professor of Medicine at Brown University School of Medicine, and Head of the Gastroenterology Section at Brown University. He is an editorial board member of Hepatology, International Hepatology Communications, Journal of Viral Hepatitis, and Viral Hepatitis Reviews. He is an editorial consultant to several outstanding journals including the Journal of Clinical 6 Cancer Detection Services PC Detect® Investigation, New England Journal of Medicine, Proceedings of the National Academy of Sciences, Journal of Infectious Disease, Gastroenterology, Journal of Virology, Virology, and Nature Medicine. Dr. Wands has served as a consultant for nearly 20-years to both the World Health Organization and the Pan American Health Organization. Hon Elinor Caplan Hon Elinor Caplan’s political career began as an elected Municipal Alderman in North York from 19781985. During that time she was chair of almost every major council committee. Elinor gained extensive experience in municipal planning, transportation & human services. She served in the Peterson Government as Minister of Government Services, Chair of Management Board & Chair of the Cabinet. Elinor Caplan is best known as Federal MP for Thornhill (1997-2004); Elinor served as Parliamentary Secretary to Minister of Health before In 2001 she was named Minister of National Revenue where she had responsibility for Revenue Canada as well as Canada Customs. Elinor had responsibility for the implementation of the Canada/USA Smart Border Accord. Her recommendation to establish the Canadian Border Services Agency was accepted by Rt Hon Paul Martin. In late 2007 Elinor completed a project for the World Health Organization (WHO) assisting with the development of an integrated Health System & legislation in Armenia. Professor Frank E. Young, M.D., Ph.D. Professor Frank E. Young, M.D., Ph.D. is a Special Consultant in Corporate Development for the Company. He was appointed Commissioner of the Food and Drug Administration in 1984 and held that post until 1989, served as Deputy Assistant Secretary for Health, Science, and the Environment from 1989 to 1993, and Director of both the Office of Emergency Preparedness and The National Disaster Medical System from 1993 to 1996. Prior to his public service with the U.S. government, Dr. Young held faculty positions and memberships in a number of universities and research institutions. These include: Case Western Reserve University; Scripps Clinic and Research Foundation; University of California at San Diego; School of Medicine and Dentistry at the University of Rochester, New York; and Strong Memorial Hospital, also located in Rochester. Dr. Young is a member of the Institute of Medicine of the National Academy of Sciences. He has published over 200 scientific and public policy publications. Hon David Caplan David Caplan was first elected to the Ontario Legislative Assembly in September 1997 and was reelected in 1999, 2003 and 2007 to serve the residents of Don Valley East. As Minster, Caplan established a four year province-wide strategy combating Diabetes; by creating a comprehensive prevention and treatment system for diabetes and other chronic diseases; organizing and expanding local access to care and support; providing tools and training to practitioners; and implementing safeguards and measures to report on progress. He is spearheading the creation of the first stand-alone infrastructure ministry in Canada. Under Caplan’s leadership, the Government of Ontario won three prestigious urban planning awards recognizing the visionary Growth Plan for the Greater Golden Horseshoe; a comprehensive 25 year strategy to maximize the benefits of population growth and maintain a high quality of life for the fastest growing region in Canada. Caplan has also assumed responsibility over major government agencies and key public assets, including the Ontario Realty Corporation, Liquor Control Board of Ontario, Ontario Lottery and Gaming Corporation and the Toronto Waterfront Revitalization Corporation. Mehdi Hatamian, Ph.D. Dr. Hatamian’s areas of expertise are high-speed VLSI signal processing, image processing, high temperature superconductors, full-custom and low power circuit and architecture design, adaptive filtering, high-density and high-speed CMOS design, and biomedical electronics. Dr. Hatamian has published nearly 50 papers in his areas of expertise and holds 81 issued patents with several patents pending. He is a Fellow member of the Institute of Electrical and Electronics Engineers (IEEE) whose technical objectives center on advancing the theory and practice of electrical engineering, electronics, computer engineering, and computer science. Election to the rank of Fellow is one of the IEEE’s most prestigious honors. He received his Fellow award for his contribution to the design of high-performance digital signal processors. Dr. Hatamian received the “#1 Patent Holder” award from Broadcom Corp. for 2005-06 and 2006-07, and the Broadcom Fellow award in 2011. He is the recipient of the University of Michigan’s ECE Alumni Merit Award for 2008-09. He has participated in numerous national and international conferences and other professional activities in his field as an organizer, session chair, 7 Cancer Detection Services PC Detect® panelist, invited lecturer, and moderator. He is also the co-founder of and the sole investor in the following companies: Smart Medical Technologies, M&T Industries, and Dragon Tale Entertainment. Dr. Hatamian received a B.S. degree in Electrical Engineering from Sharif University of Technology in Tehran, Iran and a M.S. and Ph.D. degree in Electrical Engineering from the University of Michigan in Ann Arbor. Professor David Khayat, M.D. Professor Khayat served as President of France’s Cancer National Institute from 2004 to 2006.. He has published more than 500 papers in the field of oncology and clinical pharmacology. He is chevalier of the National Order of Merit, of the Legion of Honor, of the Order of Sainte Agathe and the Academics Palms. He is the Ambassador of the Republic of San Marino at UNESCO. Since 2002, he has been a member of the “War on Cancer Plan” of Jacques Chirac. He organized French Oncologists through the French Federation of Medical Oncologists (FFOM) and was elected its first President, a position he held until 2001. Professor Khayat is a member of the Clinical Research Committee of the AACR and received the AACR Public Service Award in 2000 and a research grant from the Bristol Myers Squibb Foundation. He sits on various French, European and International Committees and is one of the members of the steering committee of the World Alliance of Cancer Research organization and the Associate Editor of the Journal of Clinical Oncology and CancerHe is member of several scientific societies and has been a member of ASCO since 1987. Professor Eleftherios P. Diamandis, PhD Dr. Diamandis is division head of clinical biochemistry in the department of pathology and laboratory medicine at Mount Sinai Hospital; biochemist-in-chief at the University Health Network and Toronto Medical Laboratories; and division head of clinical biochemistry in the department of laboratory medicine and pathobiology at the University of Toronto in Ontario, Canada. Dr. Diamandis has been active in the field of cancer diagnostics over the past 20 years. He currently chairs the National Academy of Clinical Biochemistry effort to develop guidelines for the clinical use of tumor markers. His main research interests are tumor markers, especially a group of enzymes called human tissue kallikreins. His most recent research focuses on proteomic methodologies for identifying novel cancer biomarkers and the physiology of kallikrein enzymes, as they relate to cancer initiation and progression. He is also conducting research to validate multiparametric panels for early ovarian, breast, and prostate cancer diagnosis. Dr. Diamandis serves on the boards of 25 journals. He has published more than 400 original papers and holds 13 patents, with another 20 pending. He co-authored a recent textbook, Tumor Markers. For many years, he has run workshops on tumor markers and proteomic technologies at the AACC annual meetings Carl R. Merril, M.D Dr. Merril is a leading expert and innovator on employing non-biased approaches, such as highresolution two-dimensional protein electrophoresis, to search for abnormal biochemical pathways and genomic alterations in diseases of unknown etiology that affect the central nervous system. He has published more than 200 scientific papers, is an inventor on nearly two dozen patents, and has been the recipient of numerous awards for his scientific and administrative achievements. Dr. Merril came to the National Institutes of Health since 1963 and was most recently Chief, Laboratory of Biochemical Genetics at the National Institute of Mental Health of the National Institutes of Health; he retired from NIH in 2006. Dr. Merril is an Adjunct Professor in Biochemistry and Genetics at George Washington University and an Adjunct member of the graduate faculty of the University of Maryland. He is an editorial board member of the journals Analytical Biochemistry, BioTechniques, and Insight. Dr. Merril also served as the Editor-in-Chief of Applied and Theoretical Electrophoresis and was the Senior Associate Editor of the journal Electrophoresis. He has served as President of both the International Electrophoresis Society and the American Electrophoresis Society and as Chairman of the Surgeon General’s Advisory Panel for the Research Officer Group. Oleg Sukonko, M.D. Oleg Sukonko, M.D. is Director of N.N.Alexandrov National Cancer Centre of Belarus in Minsk and Chief Oncologist of Belarusian Health Ministry. He is Professor of Oncology and author of more than 250 scientific papers in medical journals, 2 monographs and 4 patents. Prior to his current position Prof. 8 Cancer Detection Services PC Detect® Sukonko has worked as a Head of Urological Department in National Cancer Centre of Belarus from 1992 to 2010. During this time he devoted his scientific career to improvement in treatment efficacy of genitourinary malignancies, particularly renal cell carcinoma. He has led a number of clinical studies on surgical, immunological, multimodal therapy and hyperthermia of advanced renal cell carcinoma. He is an active member of Belorussian Society of Oncology, Belorussian Urological Association, Russian Society of Oncourology, European Association of Urology, American Urological Association and Société Internationale d’Urologie. He is Editor-in-Chief of Oncologicheskij Journal (Belarus) and a member of editorial board of official journal of Russian Society of Oncourology Oncourologija. Michael S. Lebowitz, Ph.D. Michael S. Lebowitz, Ph.D. has been the Director of Research at Panacea Pharmaceuticals since 2004. Dr. Lebowitz joined the Company in 2000 as a Staff Scientist and was then promoted to Director, Parkinson’s Disease Program and Project Leader, HAAH Oncology Therapeutics in early 2002. He received his Ph.D. from the Johns Hopkins University School of Medicine in Biochemistry, Cellular, and Molecular Biology. Subsequently, he completed a three year fellowship in immunology in the Department of Pathology, Division of Immunopathology also at the JHU School of Medicine. Dr. Lebowitz is also currently an adjunct Lecturer in the Advanced Academic Program in Biotechnology at the Krieger School of Arts and Sciences, JHU. Prior to joining Panacea Pharmaceuticals, Dr. Lebowitz was a research scientist at Proteinix Corporation in Gaithersburg, Maryland where he was involved in the development of compounds for the control of ubiquitin-dependent protein degradation. He has published numerous articles and abstracts in the fields of enzymology, cellular immunology, cancer, and neurodegenerative disease. He is also an inventor on several patents and has served as a principal investigator on several NIH-funded SBIR grants. Steven Fuller PhD. Dr. Fuller joined Panacea Pharmaceuticals in 2007 and serves as Vice President, Product Development. Steven has over 23 years of experience in the pharmaceutical and biotechnology industries working on a range of therapeutic and diagnostic products. Most recently Dr. Fuller served as Vice President, Product and Process Development at Nabi Biopharmaceuticals, Inc. While at Nabi, he held positions of increasing responsibility including Senior Director, Product Development and Product Development Director. At Nabi, Dr. Fuller filed a biologics license application (Common Technical Document) for a Staph aureus vaccine product in the EU, a biologics license application for a immune globulin product in the US, and Investigation New Drug (IND) applications for four vaccine products and one other therapeutic product. At ADI Diagnostics, Dr. Fuller was a Senior Research Scientist, Program Manager and Director of Operations; ADI Diagnostics is a diagnostics manufacturer and distributor specializing in cancer and infectious disease assays. He is author of numerous peer-reviewed publications and one patent. Dr. Fuller received his B.S. degree in Biology from Wheaton College and his Ph.D. in genetics from Michigan State University. He is a member of the American Society for Microbiology and the American Association for Laboratory Animal Science. Homayon Zehtab MD He continued his education in reconstructive and aesthetic surgery in Tehran University of Medical Sciences. Dr. Zehtab has many years of experience in teaching medical students, interns, residents and fellows on general and plastic surgery. Dr. Zehtab is the chief of plastic surgery department in Taleghani Hospital, Jundishapour University. He is an active member of Iranian society of General Surgeons, Iranian society of Plastic Surgeons and West Asian society of plastic surgeons. Dr. Zehtab has participated in many national and international plastic surgery conferences as a panelist, and lecturer. Dr. Zehtab has published many articles about many different types of flaps, breast cancer reconstruction using tram flaps and reconstruction of facial bones in Thalassemia patients. Currently he is the chief of plastic surgery of Apadana General Hospital, N.I.O.C. Hospital as well as founder and CEO of Pars Surgery Center in Ahvaz/Iran. Chandra J. Panchal, Ph.D. Chandra Panchal obtained a B.Sc. (1972) and a M.Sc., in Molecular Biology (1974) from the University of Toronto, and a Ph.D., in Biochemical Engineering from the University of Western Ontario (1979).Dr. Panchal is presently President & CEO at Axcelon Biopolymers Corporation, of London, Ontario, and Managing Director of Panford Investment Corp of Montreal. From 1989-1999 he was Co-founder, 9 Cancer Detection Services PC Detect® President, and CEO of Procyon Biopharma Inc., and from1999-2006 he was Chief Scientific Officer and Senior Executive VP. From 2006 to 2008 he was Executive VP, Business Development, Licensing & Intellectual Property, at Ambrilia Biopharma Inc., which was a merger between Procyon and Cellpep Inc., of France. Prior to co-founding Procyon, Dr. Panchal was a senior scientist/group leader supervising activities related to yeast genetics, fermentation and product development at John Labatt Ltd., a multinational food and beverage company. Dr. Panchal has authored over 50 scientific papers and has edited a book entitled Yeast Strain Selection, published in 1990. Dr. Panchal has been on the editorial board of the Canadian Journal of Microbiology and is a co-inventor in respect of several patents in oncology, diagnostics and industrial microbiology. Dr. Panchal is an Adjunct Professor in Chemical and Biochemical Engineering at the University of Western Ontario. He currently sits on the Boards of: Chemaphor (TSX.V: CFR), Canadian Oil Recovery and Remediation Inc.,(CORRE; TSX.V:CVR), Cardiogenics Inc.,(NASDAQ BB:CGNH.OB) Rodocanachi Capital Pool Company (TSX.V.ROD.P), and MaRS Innovation. Ladan Shariat MD, Ladan Shariat MD, Radiologist (Iran), ARDMS, CARDAP (Canada): Dr. Ladan Shariat, has been practicing medicine for many years as consulting MD for Yazd Allied Health Medical Center, Behafarin Diagnostic radiology Medical Center, Shariat Radiology and Ultrasound Center, and Sarem Hospital as Head of Diagnostic Radiology Department and Radiology in chief. Dr. Shariat has extensive experience in practicing medicine , MRI, CT Scan and Ultrasound in Iran, in addition to her observary experience in MRI and CT Scan fellowship in Toronto University Hospitals. Dr. Shariat is the Vice President of Panacea Imaging Canada Inc., and advisory board member in Panacea Global Inc and Panacea Laboratories Canada Inc. Dr. Shariat has received her MD from Beheshti University of Medical Sciences and her Radiology specialty from Tehran Medical School, 1995. Zahra Shariat Pharm.D Dr. Zahra Shariat has studied pharmacy at Azad University of Tehran/Iran and was graduated in 1994. Since 1994 to 2007 she practiced as clinical pharmacist at Fayazbakhsh Hospital, which is one of the largest hospitals in Tehran. Dr. Shariat was the pharmacist in chief and technical officer in charge, in Shariat Pharmacy in Tehran from 1997 to 2006. Dr. Shariat is an advisory Board member in Panacea Global Inc and Panacea Imaging Canada Inc. Saied Babaei MBA MD Over 15 years of global business and multi-disciplinary scientific experience in biopharma, President & CEO of AbCelex Technologies Inc. Previously held senior roles at Northern Therap; Vasogen; United Therap; and Lorus Therap. Extensive experience in establishing strategic alliances, licensing deals, joint ventures, private and public financing . Dr. Babaei also layed a key role in market launch of two biopharmaceutical products in Canada. Aras Azadian MBA, B.Econ Aras Azadian is a strategic senior consultant at Panacea Global. Subsequent his graduation from an International MBA program at EADA Barcelona Aras has been working as a consultant in financial and pharmaceutical industries. Yuri Lawryshyn, Ph.D Yuri Lawryshyn completed a Ph.D. degree in engineering at the University of Toronto specializing in Computational Fluid Dynamics (CFD), an MBA degree at the Richard Ivey Business School (UWO) and a Financial Engineering diploma at the Schulich School of Business. He has worked in a number of industries in research and development, management, marketing and strategy. In 2007, he joined the faculty of Engineering at University of Toronto, specializing in applying financial engineering principles for the valuation of real assets/projects, with specific emphasis in the development of practical approaches to real options. 10 Cancer Detection Services PC Detect® Press Releases and News Coverage 11 Cancer Detection Services PC Detect® HAAH Scientific Publications and Abstracts Publications 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. Nedim Ince, Suzanne de la Monte, Jack R. Wands. “Overexpression of Human Aspartyl (Asparaginyl) β-Hydroxylase is associated with malignant transformation.” Cancer Research: 60, 1261-1266, 2000. Eric T. Boder, Katarina D. Midelfort, and K. Dane Wittrup. “Directed evolution of antibody fragments with monovalent femtomolar antigen-binding affinity.” Proceedings of the National Academy of Sciences: 97(20), 10701-10705, 2000. Sepe PS, Lahousse SA, Gemelli B, Chang H, Maeda T, Wands JR, de la Monte SM. “Role of the aspartyl-asparaginyl-betahydroxylase gene in neuroblastoma cell motility.” Lab Invest J: 82(7):881-91, 2002. Palumbo KS, Wands JR, Safran H, King T, Carlson RI, de la Monte SM. “Human aspartyl (asparaginyl) beta-hydroxylase monoclonal antibodies: potential biomarkers for pancreatic carcinoma.” Pancreas Jul; 25(1):39-44, 2002. Commentary on Wittrup paper. “Breaking the Affinity Ceiling for Antibodies and T Cell Receptors.” Proceedings of the National Academy of Sciences: 97(20), 10679-1068, 2000. Michael J. Feldhaus, Robert W. Siegel, et al. „Flow-cytometric isolation of human antibodies from a non-immune Sacchoromyces cerevisiae surface display library.” Nature Biotechnology: 21, 163-170, 2003. Takashi Maeda, Paul Sepe, Stephanie Lahousse, Seishu Tamaki, Munetomo Enjoji, Jack R. Wands, and Suzanne M. de la Monte. “Antisense Oligodeoxynucleotides Directed Against Aspartyl (Asparaginyl) ß-Hydroxylase Suppress Migration Of Cholangiocarcinoma Cells.” Journal of Hepatology: 38, 615-622, 2003. Gregory J. Gores. Editorial: “Cholangiocarcinoma: Preventing Invasion as Anti-Cancer Strategy.” Journal of Hepatology 38, 671673, 2003. Eric P. Berthiaume, M.D., and Jack Wands, M.D. “The Molecular Pathogenesis of Cholangiocarcinoma.” Seminars in Liver Disease 24(2): 127-137, 2004. Takashi Maeda, Ken-ichi Taguchi, Shin-ichi Aishima, Mitsuo Shimada, Deborah Hintz, Nicholas LaRusso, Gregory Gores, Masazumi Tsuneyoshi, Keizo Sugimachi, Jack R. Wands, and Suzanne de la Monte. “Chinicopathological Correlates of Aspartyl (Asparaginyl) β-Hydroxylas Over-Expression in Cholangiocarcinoma.” Cancer Detection and Prevention: 28, 313-318, 2004. Suzanne M. de la Monte, Seishu Tamaki, M. Chiara Cantarini, Nedim Ince, Marcus Wiedmann, Jade J. Carter, Stephanie A. Lahousse, Sophia Califano, Takashi Maeda, Takato Ueno, Antonia D’Errico, Franco Trevisani, Jack R. Wands. “Aspartyl(asparaginyl)-β-hydroxylase Regulates Hepatocellular Carcinoma Invasiveness.” Journal of Hepatology: 44, 971-983, 2006. Zhi-Hong Xian, Shu-Hui Zhang, Wen-Ming Cong, He-Xin Yan, Kui Wang, and Meng-Chao Wu. “Expression of aspartyl betahydroxylase and its clinicopathological significance in hepatocellular carcinoma.” Modern Pathology 19: 280-286, 2006. G. Feldmann, J. Nattermann, H.D. Nischalke, M.Gorschluter, T. Kuntzen, G. Ahlenstiel, G. Ahlenstiel, T. Gerhardt, M. Wolff, T. Sauerbruch, U. Spengler, F.L. Dumoulin. “Detection of Human Aspartyl (Asparaginyl) Beta-Hydroxylas and Homeobox B7 mRNA in Brush Cytology Specimens from Patients with Bile Duct Cancer.” Endoscopy, 38:6, 604-609, 2006. M.Chiara Cantarini, Suzanne M. De la Monte, Maoyin Pang, Ming Tong, Antonia D’Errico, Franco Trevisani and Jack R. Wands. “Aspartyl-Asparagyl β hydroxylase Over-Expression in Human Hepatoma is Linked to Activation of Insulin-Like Growth Factor and Notch Signaling Mechanisms.” Hepatology, 44:2, 446-457, 2006. Stephanie A. Lahousse, Jade J. Carter, Xaolai J. Xu, Jack R. Wands and Suzanne M. de la Monte. Differential growth factor regulation of Aspartyl-Asparagyl β hydroxylase family genes in SH-Sy5y human neuroblastoma cells. BMC Cell Biology, 7:41, 1-21, 2006 WO01/35102-PCT/US00/30738: “Diagnosis and Treatment of Malignant Neoplasms”; filed November 8, 2000. US Patent 6,783,758: "Diagnosis and Treatment of Malignant Neoplasms"; Issued: August 31, 2004 US Patent 6,797,696: "Diagnosis and Treatment of Malignant Neoplasms"; Issued: September 28, 2004. US Patent 6,812,206: "Diagnosis and Treatment of Malignant Neoplasms"; Issued: November 2, 2004. US Patent 6,815,415: "Diagnosis and Treatment of Malignant Neoplasms"; Issued: November 9, 2004 US Patent 6,835,370: "Diagnosis and Treatment of Malignant Neoplasms"; Issued: December 28, 2004 US Patent 7,094,556: "Diagnosis and Treatment of Malignant Neoplasms"; Issued: August 22, 2006. Abstracts 1. 2. 3. 4. 5. S. Lahousse, P. Sepe, J. R. Wands, and S. M. de la Monte. Role of Aspartyl (Asparaginyl) β-Hydroxylase in Neuroblastoma Migration. 90th Annual Meeting of the United States & Canadian Academy of Pathology, Atlanta, Georgia, March 7, 2001. Kevin Scott Palumbo, Thomas King, Howard Safran, Jack R. Wands, Suzanne de la Monte. Potential Biomarkers for Detecting Pancreatic Carcinoma. Gastroenterology: 120, Number 5, A-161, 2001. Michael A. Rosen, Kasra Ghanbari, Alan H. Deutch, and Hossein A. Ghanbari. Development of Cancer Immunodiagnostics Using Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH) as a Biomarker. AACR-NCI-EORTC International Conference, Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications, October 29-November 2, 2001, Miami Beach, Florida. Michael S. Lebowitz, Angela H. Finney, Valery M. Nelson, Audrey A. Vasauskas, Kasra Ghanbari, Alan H. Deutch and Hossein A. Ghanbari. Inhibition of Cancer Cell Proliferation, Motility and Invasiveness by Monoclonal Antibodies Specific for Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH). AACR-NCI-EORTC International Conference, Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications, October 29-November 2, 2001, Miami Beach, Florida. Wands, Jack R.; Tamaki, Seishu; Sepe, Paul; Maeda, Takashi; Lahousse, Stephanie; and de la Monte, Suzanne M. Antisense Oligonucleotide of Human Aspartyl (Asparaginyl) β-Hydroxylase Suppresses Migration of Human Cholangiocellular Cells. American 12 Cancer Detection Services 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. PC Detect® Association for The Study of Liver Diseases - 52nd Annual Meeting November 9-13, 2001 Hepatology,: 34(4), Part II, pp. 267A, October 2001. Lawrence Glass, Kasra Ghanbari, Michael S. Lebowitz, and Hossein A. Ghanbari. Differential Expression of ASPH Gene Encoding Human Aspartyl (Asparaginyl) β-Hydroxylase in Cancer Versus Normal Tissues. AACR 94th Annual Meeting, July 11-14 2003, Washington, DC. Audrey A. Vasauskas, Cyra M. Ranji, Kasra Ghanbari, Michael S. Lebowitz, and Hossein A. Ghanbari. Human Aspartyl (Asparaginyl) β-Hydroxylase is a Serum Biomarker of Breast, Ovarian, and Prostate Cancer. AACR 94th Annual Meeting, July 11-14 2003, Washington, DC. Vasauskas, A.A., Glass, L., Ghanbari, K., Lebowitz, M.L., Ranji, C., Maric, M., and Ghanbari, H.A.: “HAAH as a Biomarker for Pancreatic Adenocarcinoma Using IHC, qRT-PCR and ELISA.” AACR—Molecular Targets and Cancer Therapeutics Meeting, November 17-21, 2003, Boston, MA. Finney, A.H., Lebowitz, M.L., Vasauskas, A.A., Ghanbari, K., Nelson, V.M., and Ghanbari, H.A.: “Anti-Proliferative and AntiMetastatic Activities of Monoclonal Antibodies to Human Aspartyl (Asparaginyl) β-Hydroxylase.” AACR—Molecular Targets and Cancer Therapeutics Meeting, November 17-21, 2003, Boston, MA. Yeung, A., Finney, A.H., Lebowitz, M.L., Ghanbari, K., Ghanbari, H.A., Wittrup, D.: “Isolation and Engineering of Biologically Active Human Single-Chain Antibody Fragments (Scfv) Against Human Aspartyl (Asparaginyl) β-Hydroxylase.” AACR—Molecular Targets and Cancer Therapeutics Meeting, November 17-21, 2003, Boston, MA A.H. Finney, M.W. D’Amico, S.F. Roberts, M.S. Lebowitz, H.A. Ghanbari. Surface Expressed HAAH in Cancer Cells is an Internalizing Antigen. AACR 97th Annual Meeting, Washington, D.C. 2006 Nelson, V.M., Finney, A.H., Drape, R.J., Bleck, G.T., Lebowitz, M.L., Ghanbari, H.A. “Manufacture of anti_HAAH Antibodies as Potential Human Therapeutics.” 1st AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development, Chicago, IL (2006) Lebowitz, M.L., Otahalova, E., Ghanbari, H.A. “A Novel Biomarker to Diagnose and Monitor Acute Myelogenous Leukemia.” 1st AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development, Chicago, IL (2006) Ghanbari, H.A., Vasauskas, A.A., Bensmail, I., Lebowitz, M.L. “HAAH is a Serum Biomarker for Prostate Cancer.” 1st AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development, Chicago, IL (2006) Otahalova, E., Lebowitz, M.L., Ghanbari, H.A. “Identification of Responders and Non-Responders to Imatinib Prior to Treatment.” 18th EORTC-NCI-AACR International Conference on “Molecular Targets and Cancer Therapeutics, Prague, Czech Republic (2006) D’Amico, MD; Roberts, SF; Lebowitz, MS; Ghanbari, HA. Use of anti-HAAH antibodies in cancer therapy: specific delivery of cytotoxic agents. AACR Annual Meeting 2007, Los Angeles, CA (2007) Semenuk, M; Repoli, AF; Lebowitz, MS; Harris, PJ; Ghanbari, HA. HAAH is a Serum Biomarker for Lung Cancer. The Second Annual AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development: Maximizing Opportunities for Personalized Treatment, Atlanta, GA (2007) Ghanbari, HA; Repoli, AF; Semenuk, M; Harris, PJ; Lebowitz, MS. HAAH as a Serum Biomarker for Breast Cancer. An AACR Special Conference in Cancer Research―Advances in Breast Cancer Research: Genetics, Biology, and Clinical Applications, San Diego, CA (2007) H.A. Ghanbari, A.F. Repoli, M. Semenuk, P.J. Harris and M.S. Lebowitz. HAAH as a serum biomarker for colorectal cancer. An AACR Special Conference in Cancer Research―Advances in Colon Cancer Research Cambridge, MA (2007) S.N. Keith, P.J. Harris, A.F. Repoli, M. Semenuk, H.A. Ghanbari and M.S. Lebowitz. The Serum Biomarker HAAH Identifies Prostate Cancer In Individuals With Low PSA Values. 2008 Genitourinary Cancers Symposium. San Francisco, CA. (2008) Michael S. Lebowitz, Angela F. Repoli, Mark Semenuk, Ilham Bensmail and Hossein A. Ghanbari. “Integration of the Cancer Biomarker, HAAH, into a Companion Diagnostic Strategy.” Oncology Biomarkers: From Discovery to Validation. San Francisco, CA (2008) Hossein Ghanbari, Valery Nelson, Angela F. Repoli, and Michael S. Lebowitz. “PAN-622, An All-Human Anti-Cancer Antibody Drug Candidate Targeted to HAAH: A Cytostatic Approach to Cancer Therapy. International Congress on Anti Cancer Treatment, Paris, France. (2008) Hossein Ghanbari, Angela F. Repoli, Mark Semenuk, Ilham Bensmail, Audrey A. Vasauskas and Michael S. Lebowitz. “HAAHbased Serum Cancer Test: A Companion Diagnostic in Cancer Therapeutics.” International Congress on Anti Cancer Treatment, Paris, France. (2008) Hossein A. Ghanbari and Michael S. Lebowitz. “In vivo efficacy of PAN-622: An All Human Sequence Monoclonal Antibody Targeted at HAAH.” AACR Annual Meeting 2008, San Diego, CA (2008) Ilham Bensmail, Michael S. Lebowitz and Hossein A. Ghanbari. “Anti-HAAH antibodies block leukemic cell activity via downregulation of the Notch signaling pathway.” AACR Annual Meeting 2008, San Diego, CA (2008) 26. D. Khayat, R. Mouawad, M. S. Lebowitz, and H. A. Ghanbari. “Serum HAAH Level in NSCLC is a Diagnostic and Could be a Predictive Factor of Clinical Response.” 44th ASCO Annual Meeting, Chicago, IL (2008). 27. Biswajit Biswas, Marjan Alaghmand, Illham Bensmail, Carl Meril, and Hossein A. Ghanbari.”Dentritic Cell-Based Center Therapeutic Vaccine targeting HAAH Using nano-Particles To Overcome Tolerance and Avoid Auto-Immune Response.” International Society for Biological Therapy of Cancer (ISBTc) 25th Annul Meeting, Bethesda, MD( 2009) 13 Cancer Detection Services PC Detect 28. H. Ghanbari, M. Moshiri ,*, M. S. Lebowitz , S. F. Roberts , A. Zokaei-Ashtiani, C. J. Panchal, “HAAH-BASED MONITORING OF CANCER REMISSION/RECURRENCE, World Cancer Congress,UICC, Montreal, ON, Canada, (2012). 29. M. Moshiri, M. S. Lebowitz , S. F. Roberts 2, C. J. Panchal, A. Zokaei-Ashtiani, H. Ghanbari “EARLY DIAGNOSIS OF CANCER: HAAH-BASED SERUM IMMUNOASSAY”, 2012-World Cancer Congress, UICC, Montreal, ON, Canada, (2012). 14 P G 330 Highway 7 East. Suite 502, Richmond Hill, On, Canda, L4B 3P8 Tel: 905.881.1049 905.881.3624 Fax: 905.881.2241 Website: www.panaceaglobalinc.com A division of Panacea Pharmaceuticals, Inc. Only a physician can order these tests. A positive test result may be due to other cancers or occasionally may have unknown causes. Panacea Laboratories developed BC DetectSM and has determined its analytical performance characteristics. Panacea Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. LC Detect is intended to be used for clinical purposes. Other serum-based tests also available from Panacea Laboratories are PC Detect® for prostate cancer screening, LC DetectSM for lung cancer screening, and CC DetectSM for detection of colorectal cancer screening.