Epigenomics AG: Clinical Data Show That Colon Polyps Can be Detected With Simple Blood Test

Prof. Dr. Matthias Ebert (Technical University of Munich, Germany) and Epigenomics Jointly Present Clinical Data From Colorectal Cancer Test Development Program


BERLIN and SEATTLE, March 20, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a cancer molecular diagnostics company, announced that Prof. Dr. Matthias Ebert, gastroenterologist at the renowned University Hospital of the Technical University of Munich, Germany, presented results of collaborative clinical studies within the company's Colorectal Cancer Screening Test Development Program at the Cambridge Healthtech Institute's inaugural conference "Epigenomics" in San Diego, CA, U.S.A. yesterday.

Prof. Ebert together with Epigenomics's Vice President Molecular Biology, Cathy Lofton-Day, Ph.D., presented data from a series of studies demonstrating that using Epigenomics' suite of proprietary DNA methylation technologies on a predefined clinical question delivers high quality biomarkers for detecting cancers organ-specific in blood plasma. The results demonstrate that the sensitive detection of methylated Septin 9 DNA in blood plasma can reliably indicate the presence of colorectal cancers of all stages. Septin 9 combined in a panel with a second DNA methylation biomarker, ALX4, also detects large polyps. These pre-cancerous lesions have a high likelihood of progressing to malignant tumors.

Epigenomics' DNA methylation technology is able to detect even a few copies of the methylated forms of these genes in blood plasma samples. Based on this principle Epigenomics develops convenient tests for the early detection of colorectal cancer and other cancers.

"Shifting early detection to pre-cancerous colorectal lesions allows the stratification of high risk individuals who will benefit from endoscopic removal of these lesions," commented Prof. Ebert. "Testing for precancerous colorectal lesions thus has the potential to prevent cancers."

The conference, which was attended by some of the world leading experts in epigenetic research, opened with a keynote by Epigenomics' Scientific Advisory Board member, Peter A. Jones, Director of the USC/Norris Comprehensive Cancer Center. Talks and discussions focused on the increasing utility of epigenetic modifications as diagnostic biomarkers and as targets for novel drugs.

Conference Presentation

The conference presentation by Prof. Ebert and Dr. Lofton-Day is available in the download section of Epigenomics' webpage. (http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/)

About the DNA methylation markers/colon cancer

The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics demonstrated in multiple clinical studies with about 3,000 blood plasma samples of colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors to the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer of all stages and in all locations. The ALX4 gene encodes for a putative transcription factor, suggesting a role in gene regulation. The data of a smaller feasibility study presented yesterday at the Cambridge Healthtech Institute's inaugural conference on epigenomics demonstrate that the presence of methylated DNA of both genes, Septin 9 and ALX4, in the bloodstream indicates the presence of larger colon polyps, that have a high likelihood of progressing to colon cancer.

About DNA Methylation

Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA's four bases, cytosine. Methylation is responsible for controlling the activity of genes by turning them off when not needed. Measuring the differences in the methylation patterns between healthy and diseased tissue can be used to detect a change in gene activity that could trigger diseases such as cancer. Similarly, DNA methylation patterns can be used to predict a patient's response to a drug. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns and uses them as biomarkers for developing molecular diagnostic and pharmacodiagnostic tests.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation markers, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:

In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer, mass-market products with huge potentials. Based on easily obtainable 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 an extensively 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, lung and breast cancer detection in body fluids. Epigenomics has full flexibility to offer these programs as attractive partnering opportunities for global development, marketing and sales in the fast growing cancer molecular diagnostics market.

As a second core business area, Epigenomics develops tissue-based prognostic tests for prostate and breast cancer patients. With a strong focus on prostate cancer applications, these tests are developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). In this area Epigenomics also retains the flexibility to decide on potential partnerships for marketing and sales

Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies protected by more than 200 patent families 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.

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.