Epigenomics Successfully Completes Larger Clinical Study in Early Lung Cancer Detection
Panel With Two Biomarkers Confirms Solid Performance in Larger Blood Plasma Study
BERLIN, Germany, and SEATTLE, WA, USA, June 18, 2008 - 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, today announced that it successfully completed a larger clinical study in its lung cancer program. The study was run in close collaboration with Prof. Dr. Christian Witt and Dr. Bernd Schmidt at the Charité University Hospital in Berlin, Germany.
The study on 256 patient samples confirmed that a two-biomarker panel correctly identified two thirds of all lung cancers in blood plasma (66% sensitivity) at a false positive rate of 12% (88% specificity). Notably, about two thirds of the blood samples used in the study were obtained from patients with early stage I and II cancer. Sensitivity in stage II lung cancer patients reached 73%. Patients with early stage cancer are significantly underdiagnosed in the current diagnostic practice for lung cancer but could benefit most from early therapeutic intervention. These latest results independently confirm previous data from a much smaller proof-of-concept study performed by Epigenomics in 2007 that was weighted towards later stage disease reflecting the unfavorable stage distribution found in the current diagnostic practice. "Today, most patients having lung cancer present with symptoms or are accidentally found, when many of them have locally advanced or metastatic disease explaining their poor prognosis. In contrast, patients diagnosed and treated at early stages can have encouraging outcomes, with 5-year survival rates as high as 60% to 70%. Identifying markers that are able to detect lung cancer using a simple blood sample is an encouraging first step towards developing a screening test for this deadly disease," says Prof. Dr. Christian Witt, Head of the Department of Pneumology at the Charité, Berlin. The biomarkers were identified within Epigenomics' proprietary discovery program using its DMH (differential methylation hybridization) technology and have been extensively validated on tissue samples before being tested on blood plasma. "With an aging population we expect to see more and more cancer patients being diagnosed. Earlier this week the German government introduced its National Cancer Plan. Similar public initiatives are pursued in the U.S. and other countries. They all aim at reducing cancer mortality and recognize that improved systematic population wide screening is key. With our convenient screening tests for lung, colorectal and prostate cancer in development we aim to contribute significantly to these efforts and make a difference to the individuals affected as well as improve the health economics of cancer care", commented Geert Nygaard, Chief Executive Office of Epigenomics. Data from Epigenomics' lung cancer program will be presented at the International Lung Cancer Conference, Liverpool, UK, July, 9 - 12, 2008 and the European Respiratory Society Annual Congress, Berlin, Germany, October, 4 - 8, 2008. About Lung Cancer With about 386,300 new cases of lung cancer in Europe and more than 174,000 new cases in the US in 2006, lung cancer is one of the most common cancers. As the leading cause of cancer death, it accounts for one in every three cancer deaths in the United States.. Currently, screening guidelines do not recommend screening for lung cancer. Diagnosis mostly relies on diagnostic imaging procedures such as x-rays, Computed Tomography (CT) scans or Positron Emission Tomography (PET) scans and invasive bronchoscopy confirmed by histological analysis for definitive diagnosis. Lung cancer patients usually are symptomatic or nodules are accidentally detected resulting in the majority having advanced disease. The overall five-year survival rate is 15% for all stages of lung cancer cases, but 49% for cases detected when the disease is still localized. The currently most promising approach to improve outcome of lung cancer is to start treatment at an early stage. However, only 16% of lung cancers are diagnosed at this early stage as symptoms occur late and the majority of lung cancer cases are diagnosed in stages too advanced for effective treatment. Non- or minimally invasive screening tests for lung cancer with high sensitivity and specificity that can be applied to large populations in a convenient, safe, and cost-effective way are urgently needed.
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 body fluids. 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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Posted: June 2008