BERLIN and SEATTLE, Sept. 18, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic tests for cancer, announces an update on its program for the development of a prostate cancer screening and diagnostic tests. The company will present recent data at two high profile European cancer research conferences, the 35th ISOBM congress (Prague/Czech Republic) and the 14th European Cancer Conference (Barcelona/Spain).
In December 2006, Epigenomics had demonstrated that its proprietary DNA methylation biomarkers can be applied to urine samples to distinguish prostate cancer patients from healthy individuals. Epigenomics now has confirmed in a further clinical study the feasibility of a urine based prostate cancer test.
In addition Epigenomics has identified dozens of additional biomarker candidates in its prostate cancer program. These new biomarker candiates may help to better distinguish prostate cancer from benign prostate conditions such as BPH (benign prostatic hyperplasia). The new biomarker candidates were discovered using Epigenomics' proprietary DMH (Differential Methylation Hybridization) technology and the most promising among them will now be analyzed in more detail in further clinical studies.
"We are excited about the progress in our prostate cancer program. The data we have collected so far look very promising - not only with regard to the application of our biomarkers for prostate cancer screening, but also for the actual diagnosis of prostate cancer. They may support the development of a follow-on test to PSA testing, the currently widely applied screening test. Such a test could spare many men unnecessary and painful biopsies, when they have an elevated PSA level, but possibly no cancer," explained Christian Piepenbrock, Chief Operating Officer of Epigenomics.
Conference Presentation Details
35th Congress of the International Society for Oncodevelopmental Biology and Medicine Prague, Czech Republic, September 15th - 19th, 2007. isobm07.vscht.cz/ Presentation: DNA methylation markers for diagnosis and prognosis of prostate cancer by Dr. Ralf Lesche, Vice President Biomedical R & D, Epigenomics AG
14th European Cancer Conference (ECCO 14) Barcelona, Spain, September 23rd - 27th, 2007. www.fecs.be/ Poster presentation: Urine is a superior remote body fluid for early detection of prostate cancer using real time PCR detection of DNA methylation markers (Abstract 4.009) by Shannon R. Payne, PhD, Scientist, Epigenomics AG.
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 US and Europe, one in six men will be diagnosed with prostate cancer in his lifetime and about 115,000 men in the US 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 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. Thus, DNA methylation in Epigenomics' view 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.
About Epigenomics AG
Epigenomics is a molecular diagnostics company focusing on the development and commercialization of cancer tests for cancer screening and cancer specialty applications. Using DNA methylation biomarkers, Epigenomics' tests can potentially diagnose cancer at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' business is divided into two core business areas:
In its cancer screening diagnostics business area, the company actively pursues the development of in vitro diagnsotic 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.
In its second core business area, cancer specialty diagnostics, Epigenomics develops tests 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 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 events or otherwise.