BERLIN and SEATTLE, Oct. 10, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX) (ISIN:DE000A0BVT96) today announced the formation of its Colorectal Cancer Medical Advisory board and the appointment of its first four members. The board will advise Epigenomics on important aspects of the clinical development and commercialization process of the colorectal cancer screening test in the U.S. The inaugural meeting of the board will be held on October 12, 2007 in Philadelphia, PA, U.S.A.
The members of the board include Douglas Rex, MD, Chancellor's Professor and Professor of Medicine at Indiana University School of Medicine;
Philip S. Schoenfeld, M.D., M.Ed., M.Sc., Associate Professor, Department of Internal Medicine, University of Michigan School of Medicine;
Deborah Fisher, MD, MHS, Assistant Professor of Medicine, Duke University, and Scott Ramsey, M.D., Ph.D., Associate Professor of Medicine and Health Services, Associate Member, Cancer Prevention Research Program, Fred Hutchinson Cancer Research Center.
The four initial members represent a cross section of gastroenterologists with particular expertise in colonoscopy, colorectal cancer screening, evidence-based medicine, outcomes research, and health economic analysis. Epigenomics' Medical Advisory Board will support the company and its corporate partners through design of its prospective clinical validation study and ancillary studies, speaking on behalf of the application of DNA methylation technology to colorectal cancer screening in the U.S., advising on product positioning in the U.S.and support inclusion of blood screening assays into screening guidelines promulgated by US American professional societies.
"We are very excited having such renowned U.S. cancer specialists join our medical advisory board. We believe that this esteemed board will provide the expertise and medical oversight to help us effectively move our key value driver, the colorectal cancer screening test from research and development through the clinical validation process, towards product approval and launch in the important U.S. market. We are looking forward to working with these well-recognized clinicians," commented Michael Wandell, Pharm.D., Senior Vice President, Clinical and Regulatory, of Epigenomics.
About the Medical Advisory Board Members
Douglas Rex, MD, is Chancellor's Professor and Professor of Medicine at Indiana University School of Medicine and Director of Endoscopy at Indiana University Hospital. As former Chair, U.S. Multi-Society Task Force on Colorectal Cancer, Dr. Rex has been a leading author on key screening guideline documents.
Deborah Fisher, MD, MHS, is Assistant Professor of Medicine, Duke University and core investigator with the Durham VA Health Services Research and Development Center of Excellence. A recipient of Research Excellence in GI and Liver (REGAL) Award, Dr. Fisher's research agenda is to close the gap between guidelines and actual clinical practice for colorectal cancer prevention and detection. Her NIH and VA funded work has evaluated the process of follow-up care for screening and surveillance, validated self-reported screening status, assessed quality indicators, and explored screening appropriateness.
Philip S. Schoenfeld, M.D., M.Ed., M.Sc., is Associate Professor, Department of Internal Medicine, Director, Training Program in GI Epidemiology University of Michigan. Dr. Schoenfeld's research interests have been centered on colorectal cancer screening with colonoscopy and stool tests, cost-effectiveness of colorectal cancer screening and surveillance, and adoption of colorectal cancer screening guidelines.
Scott Ramsey, M.D., Ph.D. is Associate Professor of Medicine and Health Services, Associate Member, Cancer Prevention Research Program, Fred Hutchinson Cancer Research Center. Dr. Ramsey's research interests have focused on the cost effectiveness analyses of colorectal cancer screening, health economic analyses, and cancer therapy outcomes research.
About Colorectal Cancer Testing and the Septin 9 Biomarker
Colorectal cancer is the second leading cause of cancer related death. With a 5-year-survival rate of above 90 percent if diagnosed in early stages, early detection through testing would be valuable. This type of test targets almost 300 million people in Europe, the U.S., and Japan, a market that, in our opinion, is worth more than USD 3 billion in total. The gold standard screening test is colonoscopy, an invasive procedure, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is not widely used at short intervals. A non-invasive first-line test therefore would be useful to screen individuals at risk so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the fecal occult blood testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low (approximately 16 percent in the United States). The introduction of a more convenient, patient-friendly test could potentially increase the number of individuals tested. If positive, the patients would be followed up by colonoscopy. This could increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer.
Epigenomics' technology sensitively detects DNA based on specific DNA methylation patterns in blood plasma samples or other body fluids. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with about 3,000 blood plasma samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer.
About DNA methylation
DNA methylation is a tightly controlled biological process that fundamentally affects gene expression and genome stability. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity. Every cell type has its unique DNA methylation "fingerprint" that changes in various normal biological processes and in many diseases, in particular cancer. In our opinion, DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.
About Epigenomics AG
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests can potentially diagnose cancer at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:
The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains a validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. Epigenomics aims at giving patients, and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players. As a first strategic partner, Abbott Molecular licensed the worldwide non-exclusive rights to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer.
As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe.
Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 190 patent families (granted patents and patent applications) through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics' website at www.epigenomics.com.
Epigenomics' Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future event or otherwise.