Berlin, Germany and Seattle, WA, U.S.A., January 21, 2008 -- Epigenomics AG (Frankfurt Prime Standard: ECX; ISIN: DE000A0BVT96) today announced the expansion of its Colorectal Cancer Medical Advisory Board with the appointment of Richard Wender, MD, Alumni Professor and Chair of the Department of Family and Community Medicine at Thomas Jefferson University in Philadelphia, PA. The board advises Epigenomics on important aspects of the clinical development and commercialization process of the colorectal cancer screening test in the U.S.
The members of the board now include:
Richard Wender, MD, Alumni Professor and Chair of the Department of Family and Community Medicine at Thomas Jefferson University in Philadelphia, PA,
Douglas Rex, MD, Chancellor’s Professor and Professor of Medicine at Indiana University School of Medicine and Director of Indiana University Hospital, in Indianapolis, IN,
Philip S. Schoenfeld, MD, MEd, MSc, Associate Professor, Department of Internal Medicine, University of Michigan in Ann Arbor, MI,
Deborah Fisher, MD, MHS, Assistant Professor of Medicine, Duke University in Durham, NC, and
Scott Ramsey, MD, PhD, Associate Professor of Medicine and Health Services, Associate Member, Cancer Prevention Research Program, Fred Hutchinson Cancer Research Center in Seattle, WA.
The members represent a cross section of primary care physicians and 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 their 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 U.S. professional societies.
“We are very excited to have such a renowned expert join our medical advisory board on the back of a successful meeting with the FDA that we held in late December 2007 with our partners. 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, PharmD, Senior Vice President, Clinical Regulatory and Quality, of Epigenomics.
About the Medical Advisory Board Members
Richard Wender, MD, is Alumni Professor and Chair of the Department of Family and Community Medicine at Thomas Jefferson University in Philadelphia, PA. A graduate of Princeton University and the University of Pennsylvania School of Medicine, Dr. Wender, directed the Family Medicine residency program at Thomas Jefferson for 10 years and became Vice Chairman of the Department in 1995. He was appointed Chair of the Department in August of 2002. In addition to being a practicing family doctor, his major area of academic focus has been cancer prevention and screening. He was the editor of the American Cancer Society Primary Care Physicians Newsletter for 10 years and is now on the Editorial Advisory Board of CA -- A Cancer Journal for Clinicians. Dr. Wender has served in leadership positions of professional societies at the state and national level including co-chair of the Professional Education and Practice Task Group and the Steering Committee of the National Colorectal Cancer Roundtable. Dr. Wender worked with the CDC to develop a national training program for clinicians about colorectal cancer prevention and screening. He is the recipient of the St. George Medal from the American Cancer Society and the Cancer Prevention Laurel for National Leadership from the Cancer Research and Prevention Foundation. 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 in Indianapolis, IN. As former Chair, US Multi-Society Task Force on Colorectal Cancer, Dr. Rex has been a leading author on key screening guideline documents.
Philip S. Schoenfeld, MD, MEd, MSc, is Associate Professor, Department of Internal Medicine, Director, Training Program in GI Epidemiology University of Michigan in Ann Arbor, MI. 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.
Deborah Fisher, MD, MHS, is Assistant Professor of Medicine, Duke University in Durham, NC, 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.
Scott Ramsey, MD, PhD is Associate Professor of Medicine and Health Services, Associate Member, Cancer Prevention Research Program, Fred Hutchinson Cancer Research Center in Seattle, WA. 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 Screening 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 at an early stage, early detection through blood based testing would be valuable. This type of test targets almost 300 million people in Europe, the U.S., and Japan, a market that, in Epigenomics’ 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. 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 aim at sensitively detecting 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. As a first strategic partner, Abbott Molecular, Inc. licensed the worldwide non-exclusive rights to Epigenomics’ proprietary Septin 9 biomarker for colorectal cancer in September 2007. The companies anticipate launching a CE-marked blood test in Europe in 2009 followed by regulatory filing for U.S. approval in 2010.
About DNA methylation
DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. 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 companies. As a first strategic partner, Abbott Molecular, Inc. 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 GmbH (pre-analytics) and Affymetrix, Inc. (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 150 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.
