October 27, 2008
Epigenomics AG Reports PRESEPT Clinical Study Progress
-- Successfully qualified 17 PRESEPT clinical sites; 12 sites initiated -- Enrollment nearly 500 hundred subjects in first three months -- Expanded clinical site network to include first site in Germany -- Launched PRESEPT Study website found at www.presept.net -- Added Prof. Dr. Thomas Rosch to the Clinical Study Steering Committee -- Appointed Dr. Timothy R. Church responsible for study results analysis -- Clinical Study Steering Committee recommends strengthening design by dropping interim analysis
BERLIN and SEATTLE, Oct. 27, 2008 (GLOBE NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a cancer molecular diagnostics company developing tests based on DNA methylation, today reported the PRESEPT Clinical Study Steering Committee had reviewed the substantial progress that has been made in the execution of the PRESEPT Study. In addition, Dr. Timothy Church has been assigned responsibility for study results analysis and Prof. Dr. Thomas Rosch has been added to the Committee as representative of the German sites.
Since starting the PRESEPT Study in Q2 of 2008, Epigenomics has successfully qualified 17 clinical sites, 12 of which have been initiated, enrolling nearly 500 subjects in the first three months. The increased number of clinical sites is expected to now rapidly ramp up accrual of subjects over the next several months.When the total of up to 20 clinical sites including three in Germany are initiated, PRESEPT will be one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. Epigenomics is providing clinical collaborators, medical professionals, and the interested public with study details and regular updates on the progress of the PRESEPT Study on the recently launched website www.presept.net.
Among those clinical sites recently added to the PRESEPT Study was the first German investigator, Dr. Alireza Aminalai, in Berlin, Germany. Dr. Aminalai is a member of the Berlin Endoscopy Study Team (BEST), a regional group of gastroenterologists with a clinical research interest in gastrointestinal disorders. The BEST group is affiliated with the regional organization of private practice gastroenterologists, which also promotes initiatives of physicians in the Berlin area with the goal to enhance awareness for colorectal cancer and to promote screening.
"German gastroenterologists are determined to reduce mortality of colorectal cancer by half in the forseeable future. This goal can only be reached by the implementation of additional screening methods complementing the current gold standard of colonoscopy. I am therefore pleased to join the network of PRESEPT investigators to evaluate a new approach for colorectal cancer screening. We have the sincere hope that a blood-based test could bring more people to accept colorectal screening who may not primarily opt for colonoscopy but would accept to undergo colonoscopy for definite diagnosis when tested positive," Dr. Aminalai explained the rationale behind his support of the PRESEPT Study.
The research activities of the BEST group, which has successfully conducted several colorectal cancer studies in the past, are coordinated by Prof. Dr. Thomas Rosch, Director of the Clinic for Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf and newly appointed member of the PRESEPT Clinical Study Steering Committee.
"I am excited to join the PRESEPT Clinical Study Steering Committee and participate in this extremely important initiative. The availability of a simple, convenient blood test for colorectal cancer screening has the potential to significantly improve patient compliance, and as a result increase survival due to early detection of disease," stated Prof. Rosch, "and including German sites into the PRESEPT Study will make overall study results even more compelling to European gastroenterologists."
In its most recent meeting in Chicago, IL, USA on 23 October 2008, the CSSC strongly advised the study's sponsor, Epigenomics, not to undertake an interim analysis of clinical results in early 2009, but rather to only conduct a final analysis when enrollment is complete. The Committee recommended this course to strengthen the overall study design by avoiding the statistical penalty on the study's overall power incurred by conducting an interim analysis.
"Given the relatively short period between a possible interim analysis in H1 2009 and the final analysis planned for H2 2009, the study would incur a statistical penalty associated with the interim analysis without clear scientific benefit," reported Committee Chairman, David Ransohoff. "We established the Committee to provide us oversight, study design advice and independent analysis, and we will heed their recommendation. We all believe that the final results of the PRESEPT Study will be that much stronger for it," commented Michael Wandell, Pharm.D., Epigenomics' PRESEPT Study Director. "We have made excellent progress in study execution and we believe the Committee's advice is the correct course, even if it means our first look at the results will not occur until a little later in 2009."
Epigenomics assembled and empowered the Clinical Study Steering Committee (CSSC) to advise the sponsor on the PRESEPT Study design, oversee the quality of the study conduct according to worldwide clinical research practice standards, and independently analyze and accurately report the results. The CSSC is chaired by David Ransohoff, MD, Professor of Medicine, Cancer Epidemiology, Cancer Prevention and Control, University of North Carolina School of Medicine, and its members include Neal Osborn, MD, Co-Director of Clinical Research, Atlanta Gastroenterology; Timothy R. Church, PhD Professor, School of Public Health, University of Minnesota; Brent Blumenstein, PhD, Principal, Trial Architecture Consulting; Dale Snover, MD, Adjunct Professor, Department of Laboratory Medicine and Pathology, University of Minnesota Medical School; Robert Day, MD, PhD, President Emeritus of The Fred Hutchinson Cancer Research Center (ex officio); and Prof. Dr. Thomas Rosch, Director of the Clinic for Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf. In addition to the external participants, two sponsor representatives, Michael Wandell, PharmD, Study Director and Cathy Lofton-Day, PhD, Project Manager, are CSSC members.
PRESEPT is a multinational, multi-center clinical study sponsored by Epigenomics to prospectively evaluate the clinical performance of Epigenomics' proprietary biomarker, Septin 9, for colorectal cancer population screening in guideline-eligible individuals. It is one of the first studies ever to evaluate the performance of a noninvasive test to indicate the presence of colorectal cancer in asymptomatic individuals in a standard blood sample. The study is designed to enroll up to 7,500 asymptomatic subjects aged 50 or older at average to increased risk for colorectal cancer who have been scheduled for a regular screening colonoscopy at up to 20 clinical sites in the U.S. and Germany. This population is expected to harbor about 50 cases with undetected colorectal cancer.
The study is intended to characterize the performance characteristics and evaluate the health economic benefit of the Septin 9 marker with the goal to demonstrate it will meet the requirements of current U.S. screening guidelines for non-invasive screening tests. The clinical performance and health economic analysis results are expected to support future coverage by public and private health insurers worldwide. Further, Epigenomics will provide industry partners developing Septin 9 IVD tests access to the PRESEPT samples and data to perform pivotal clinical trials necessary to obtain regulatory approvals. For more information and regular updates please visit www.presept.net.
About Colorectal Cancer Screening
Colorectal cancer is the second leading cause of cancer related death in the U.S. with an estimated direct medical treatment cost of $8.3 billion in 2007. With a cure rate of over 90% if diagnosed in early stages in the United States, there is now general agreement that average-risk adults aged 50 and older should be screened for colorectal cancer. If detected early, individual treatment costs for colon cancer are estimated at $30,000 per patient, whereas treatment for a patient who has developed late stage disease is estimated at $120,000. However, less than 50% of the screening population has had a recent test. Given today's treatment options for colorectal cancer, patient outcomes could potentially be greatly improved if more cancers were detected in early stages.
However, from a public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of colorectal cancer screening initiatives; Current colorectal cancer screening guidelines include two types of tests, those that detect polyps and cancer such as colonoscopy and virtual colonoscopy and those that detect cancer such as the non-invasive stool based tests. Non-invasive screening is most often conducted using FOBT, which while inexpensive, exhibits a low compliance rate due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for colorectal cancer detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, convenient, blood-based screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.
About the Septin 9 Biomarker
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 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of the Septin 9 gene 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 IVD rights to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer. In addition, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.
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 to 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. 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 in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
Epigenomics' product pipeline contains a validated biomarker 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 urine, blood and bronchial lavage specimens. Epigenomics' biomarker Septin 9 for the early detection of colorectal cancer in a simple blood sample demonstrated continuously highest performance in multiple clinical studies with in total about 3,500 individuals tested.
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 IVD rights to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.
Partners in the health care industry and the biomedical research community can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics' website at www.epigenomics.com.
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 events or otherwise.
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