BERLIN and SEATTLE, June 9, 2008 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer based on DNA methylation, today announced that it successfully completed a 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 Charite -- Universitatsmedizin Berlin, Germany.
The clinical study of 84 patient samples demonstrated that a panel of two proprietary biomarkers detected 79% of lung cancers in bronchial lavage specimens at specificity of 95%, i.e. only two false positives results were obtained in 45 patients with benign lung diseases.
Bronchial lavage specimens are routinely taken during bronchoscopy that is performed to diagnose lung cancer. In current clinical routine, the bronchial lavage fluid is analyzed by a pathologist to identify tumor cells. However, this microscopic analysis often cannot either confirm or exclude lung cancer. A molecular diagnostic test that sensitively and objectively detects the presence of tumor cells in this specimen could potentially improve clinical decision making for patients with suspected lung cancer.
"Bronchial lavage is a bronchioscopic standard procedure that is used in lung cancer diagnosis when the tumor is not visible in the larger airways. Yet, the detection of tumor cells not always works in the lavage fluid. Molecular markers with the performance demonstrated in our study could be of substantial benefit in this situation," says Prof. Dr. Christian Witt, Head of the Department of Pneumology at the Charite, Berlin.
The set of biomarkers comes out of Epigenomics' biomarker discovery program using its proprietary DMH (differential methylation hybridization) technology and has been extensively validated in tumor tissue specimens before being tested on bronchial lavage. The assay procedure used in this study relies on readily available solutions for sample preparation including the EpiTect(r) kit for bisulfite conversion marketed by Qiagen under license from Epigenomics.
"These data mark an important milestone in our lung cancer program," commented Geert Nygaard, Chief Executive Officer of Epigenomics. "The outstanding performance in high-risk patients opens up the opportunity to develop or partner a product for additional indication areas such as a radiology/CT reflex testing prior to lung biopsies. I am very pleased with the execution of this clinical study that was successfully completed ahead of schedule."
The detailed results of the study will be presented at the International Lung Cancer Conference, Liverpool, UK, July 9 - 12, 2008.
As next steps in its lung cancer program, Epigenomics expects to further optimize the biomarker panel for application in bronchial lavage specimens and perform an additional clinical study to confirm the biomarker performance in an independent population. Based on the outcome of this effort, the Company will evaluate the potential development or partnering of a bronchial lavage diagnostic product.
The company also progressed the development of its lung cancer early detection test and is in the final phase of a clinical study testing blood plasma. This study aims at confirming the performance of a biomarker panel for a potential lung cancer screening application in a sizable sample set using an assay procedure that was optimized with respect to costs, throughput and applicability in the clinical routine. Data from this study is expected to be released in due course.
About Lung Cancer
With about 386,300 new cases of lung cancer in Europe and over 174,000 new cases in the U.S. in 2006, lung cancer is one of the most common cancers in men and women accounting for about 20 percent of all cancer deaths, more than any other cancer.
Despite the impressive progress of diagnostic imaging technologies, the final cancer diagnosis still depends on the investigation of tissues or cells by a pathologist.
Therefore in addition to Computed Tomography (CT), most individuals suspected to have lung cancer undergo bronchoscopy, the main modality used to further investigate these patients. Every year more than 200,000 bronchoscopies are performed in Germany alone, about 95% of them due to a suspected tumor. Some tumors are visible in the central airways and can be easily accessed for the examination by the pathologist. If a lesion is beyond the scope of the endoscope, bronchial lavage is routinely performed and the cells that are washed out with the lavage fluid are sent for cytological examination, which unfortunately has low sensitivity in diagnosing malignant lung tumors. As a consequence, non-diagnostic results are not uncommon and often lead to additional invasive procedures that are costly and pose a considerable risk to the patients.
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. 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.
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.