BERLIN and SEATTLE, April 14, 2008 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic tests for cancer, updates on its program for the development of test for prostate cancer screening and diagnosis. The company presented recent data at this year's Annual Meeting of the American Association for Cancer Research (AACR) in San Diego, USA.
Epigenomics had previously demonstrated that its proprietary DNA methylation biomarkers can be measured in urine samples to distinguish prostate cancer patients from healthy individuals. In a subsequent clinical study in 2007 Epigenomics further confirmed the feasibility of a urine-based prostate cancer test.
In a systematic genome-wide screen using Epigenomics' proprietary differential methylation hybridization (DMH) technology, Epigenomics has now identified novel biomarkers in its prostate cancer program. The study included tissue samples from patients with prostate cancer, benign prostate conditions, and age-matched normal controls. Biomarkers discovered by DMH were subsequently validated by real-time PCR technology in an independent sample set. A total of 26 novel biomarkers were successfully validated in this study, a number of which specifically discriminate prostate cancer from benign prostate conditions such as BPH (benign prostatic hyperplasia). These biomarkers have the potential to augment diagnostic specificity of the best-characterized prostate cancer methylation biomarker, GSTP1. The discrimination of prostate cancer from benign prostate conditions is one of the major shortfalls of PSA (prostate specific antigen) testing, the current standard in prostate cancer screening. Epigenomics will now further optimize analytical PCR assay performance and validate the most promising candidate biomarkers in a clinical study on urine samples.
"We are all very excited about the progress in our prostate cancer program. The data on these novel biomarkers look very promising. Prostate cancer screening biomarkers with the diagnostic ability to discriminate prostate cancer from BPH in patients with elevated PSA levels would be an invaluable tool for the public health management of prostate cancer," stated Shannon Payne, PhD, project manager and scientist at Epigenomics.
Poster Reference
Payne S. et al. A genome-wide screen for DNA hypermethylation in prostate cancer identifies novel methylation biomarkers with high specificity for prostate cancer versus benign prostatic hyperplasia. In: Proceedings of the 99th Annual Meeting of the American Association for Cancer Research; 2008 Apr 12-16; San Diego, CA. Philadelphia (PA): AACR; 2008. Abstract nr 34
The Poster will be available for download after the conference from Epigenomics' website at http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/
About Prostate Cancer
Prostate cancer is the most common cancer in American and European men. With an annual incidence of approximately 470,000 cases in the U.S. and Europe, one in six men will be diagnosed with prostate cancer in his lifetime and about 115,000 men in the U.S. and Europe will die from the disease every year. As with other cancers, the stage of disease at diagnosis affects overall survival rates and patients diagnosed with local or regional disease have a five-year survival rate of nearly 100%.
The current guidelines for prostate cancer screening, according to the American Cancer Society, advise testing for elevated prostate-specific antigen (PSA) and digital rectal examination (DRE) annually, beginning at the age of 50, in certain risk groups at the age of 45. Positive findings in either of these exams may be followed by prostate biopsy for confirmation.
PSA testing, although widely used, has certain disadvantages: PSA as a tumor biomarker has a moderate specificity, i.e. it is also elevated in a number of benign prostate conditions leading to a number of unnecessary prostate biopsies in men without prostate cancer. Furthermore, despite acceptable sensitivity of PSA, a subgroup of cancer patients does not show elevated PSA. Improved tests with increased specificity and sensitivity are therefore needed. The objective of Epigenomics' prostate cancer screening test program is to develop a screening test for men over 50 years of age that is based on a panel of DNA methylation biomarkers and is more specific than PSA testing or can be used as a diagnostic follow-on for men with PSA elevated to 2.5 ng/ml or more.
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. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.
About DMH
Differential Methylation Hybridization (DMH) is the most recent addition to Epigenomics' proprietary DNA methylation technology portfolio. With Epigenomics' DMH microarrays more than 50,000 human genomic fragments can be profiled for their methylation status in a single experiment. DMH is robust and delivers highly reproducible results. This makes DMH in Epigenomics' view a fast and cost-effective tool to discover novel DNA methylation biomarkers for diagnostic and pharmacodiagnostic applications. Epigenomics offers DMH biomarker discovery on human and mouse tissue samples as a biomarker service to its customers. Please visit Epigenomics' website for more information (www.epigenomics.com).
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 thereby may reduce mortality from this dreaded disease.
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 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. 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. 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, USA. For more information, please visit Epigenomics' website at www.epigenomics.com.
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 events or otherwise.