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Epigenomics AG (OJ:ECX) - Clinical study of over 500 patient samples well on track for completion in Q4 2008 - Interim analysis representing approximately half of the cases demonstrates statistical significance for primary endpoint of prostate cancer prognosis (probability of recurrence) - PITX2 biomarker classifies patients into groups at high and low risk for relapse following surgery
Berlin, Germany and Seattle, WA, USA, September 8, 2008 - Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company developing tests based on DNA methylation, today reported positive interim results from an ongoing prostate cancer trial.
"Upon completion of testing about half of the patient samples for PITX2 methylation we have conducted a scheduled interim analysis", commented Dr. Gunter Weiss, Product Development Manager at Epigenomics. "This analysis shows that we are on a very promising path to show that PITX2 methylation is indeed a strong, independent prognostic marker. The Interim analysis demonstrated statistical significance for the primary endpoint," Dr. Weiss added.
The clinical study is analyzing paraffin embedded tissue samples from over 500 prostate cancer patients who had undergone radical prostatectomy, collected at four major clinical centers in Europe and the USA with the, objective of validating the prognostic utility of Epigenomics' proprietary biomarker, PITX2. The primary endpoint of the study is to evaluate the methylation status of the PITX2 gene as an independent prognostic biomarker indicative of the risk prostate cancer recurrance in patients following removal of the entire prostate, known as radical prostatectomy. The study is also analyzing whether measurement of PITX2 methylation adds clinical information to established prognostic parameters such as Gleason score, tumor staging, pre-surgical PSA levels and surgical margin status. The study is expected to validate the clinical utility of PITX2 for prostate cancer prognosis first established in a 2006 clinical study on 605 prostatectomy tissue samples. The biomarker is extremely robust and may be measured using an Affymetrix microarray platform, as well as other assay technologies suitable for routine clinical use, creating maximum flexibility for routine clinical use and commercialization.
Epigenomics plans to complete the clinical study by the end of the third quarter and data analysis should be finalized in October. Epigenomics will analyze the study results with its clinical collaborators at Baylor College of Medicine, Houston Texas, USA and Erasmus MC, Rotterdam, The Netherlands, Duke University, Durham North Carolina, USA, and the VA Medical Center at Durham, North Carolina, USA in a joint meeting scheduled for early October 2008. Headline results from the completed study are expected to be released shortly thereafter and are planned for publication in a peer reviewed journal in due course.
"Since Epigenomics is focused primarily on its body-fluid-based early cancer detection programs in colorectal, lung and prostate cancers, we do not intend to manufacture and market the assay ourselves" stated Geert Nygaard, Chief Executive Officer of Epigenomics. "Nevertheless, we want to make the test available to clinicians and patients as soon as possible. To this end we are exploring several opportunities to partner PITX2, which has potential applications beyond prostate cancer prognosis, such as in breast cancer. Commercial options include licensing the biomarker and a suitable assay technology to reference laboratories, the launch of RUO products for clinical research in Europe, and potentially the transfer of the fully developed assay system to suitable partners for regulatory submission and commercialization as an IVD product" Geert Nygaard added. About Epigenomics' Prostate Cancer Molecular Classification Test 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 100,000 men will die from the disease every year. Surgical removal of the prostate (radical prostatectomy) is performed as potentially curative treatment in about 40% of patients diagnosed with prostate cancer. Nevertheless, the disease recurs in about one in seven prostatectomy patients. However, the difficulty clinicians have is that even with the use of current prognostic parameters, there still remains considerable uncertainty concerning which patients will eventually relapse. Epigenomics is developing a prostate cancer molecular classification test based on the DNA methylation biomarker PITX2 that will provide physicians and patients with prognostic information on disease recurrence by identifying those prostatectomy patients at increased risk. Currently, prognostic information is mainly derived from clinical and histopathological parameters, such as tumor size, Gleason score and pre-surgery PSA levels. In a study published at the 2006 annual AACR meeting, Epigenomics has shown that DNA methylation of PITX2 constitutes a strong prognostic marker for outcome prediction after radical prostatectomy. In this study, PITX2 separated post-prostatectomy cancer patients into two distinct groups: Those with a high likelihood of cancer recurrence and those with a low likelihood of cancer recurrence. Furthermore, PITX2 methylation added significant information to established clinical parameters. Remarkably, the PITX2 biomarker was able to predict outcome in patients diagnosed with Gleason 7, for which reliable prognosis based on conventional parameters is particularly difficult. The demand among physicians for such a molecular diagnostic test is high, since it identifies patients with a poor prognosis that are possibly under-treated. 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 more than 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.
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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.
Contact:
Epigenomics AG Oliver Schacht, PhD CFO Phone: +49 (0) 30-24345-331 Email: oliver.schacht@epigenomics.com
