29.05.2009 – 10:02
EANS-News: Epigenomics AG Presents Clinical Data from Prostate Cancer Prognosis Study at ASCO
Biomarker mPITX2 for prostate cancer prognostic application successfully validated First clinical laboratory in Germany to start offering mPITX2 testing service
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new product/research/Molecular diagnostics
Press release, Berlin, Germany and Seattle, WA, USA, May 29, 2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer detection based on DNA methylation, will present clinical data from its study validating the mPITX2 biomarker in a prognostic setting in prostate cancer at this year's ASCO (American Society of Clinical Oncology) conference in Orlando, Florida, USA. The data will be presented by Esmeralda Heiden, M.D., Ph.D., Pathologist at Epigenomics, on May 31, 2009 in a poster presentation titled "PITX2 methylation and biochemical recurrence in postradical prostatectomy prostate cancer patients".
The mPITX2 biomarker is at the core of Epigenomics' prostate cancer prognosis test that indicates the risk of early disease recurrence following a surgical removal of the cancerous prostate. Epigenomics has successfully validated the biomarker using a fully developed test system for this application.
"Assessing PITX2 methylation could provide a valuable means to better define prostate cancer risk groups and thus aid in selection of patients for whom adjuvant and/or early salvage therapy may be warranted," commented Lionel Bañez, M.D., one of the clinical collaborators in the validation study. "Furthermore, PITX2 methylation status could also be used in the rational design of clinical trials and improve testing of new therapeutic regimens." Dr. Bañez is affiliated with the Division of Urologic Surgery and the Duke Prostate Center at Duke University Medical Center in Durham, North Carolina. Further clinical sites collaborating in this international multicenter study also included the Baylor College of Medicine, Houston, Texas, USA, the Erasmus Medical Center, Rotterdam, The Netherlands, the VA Medical Center at Durham, North Carolina, USA, and the University Hospital Erlangen, Erlangen, Germany.
The pathology laboratory of Prof. Dr. Arndt Hartmann at the University Hospital Erlangen in Germany is the first of a selected number of laboratories that Epigenomics has now enabled under its "Early Access Program" to offer mPITX2 testing services in Germany. Prof. Dr. Arndt Hartmann, Director of the Institute of Pathology at the University Hospital in Erlangen commented the study results and why his lab will start offering mPITX2 testing: "Technically, this has been a perfect study. For all but a single patient a valid PITX2 measurement has been provided. The technology is mature and ready for release."
2009 ASCO Annual Meeting Presentation Details
The poster titled "PITX2 methylation and biochemical recurrence in postradical prostatectomy prostate cancer patients" will be presented by Esmeralda Heiden, MD, PhD, in the Session Genitourinary Cancer on May 31, 2009, 2 -6 pm on Level 2 in West Hall C at the 2009 ASCO Annual Meeting, May 29 to June 2, 2009, in Orlando FL, U.S.A.
About Epigenomics' Prostate Cancer Prognosis 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 prognosis test based on the DNA methylation biomarker PITX2 (mPITX2) that may provide physicians and patients with prognostic information by identifying those prostatectomy patients at increased risk for early disease recurrence. 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. Epigenomics is in the process of making mPITX2 available at selected clinical centers in Europe within an "Early Access Program" for this biomarker. For broad commercialization, Epigenomics intends to partner the test with suitable players in the diagnostics industry.
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 mSEPT9 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. A large prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a screening population is currently under way (www.presept.net).
For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation and Quest Diagnostics Incorporated for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.
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.
Epigenomics legal disclaimers. 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.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
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