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26.05.2009 – 11:02

Epigenomics AG

EANS-News: Novel German Research Alliance to Detect Precursors of Colorectal Cancer - Munich Technical University, Epigenomics AG and KVB to develop novel approaches to cancer prevention

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research/new product/molecular diagnostics

Berlin and Munich, Germany, May 26, 2009 (euro adhoc) - The German Federal Ministry of Education and Research will fund a clinical research project for the early detection of colorectal cancer, to be realized by an alliance of Scientists from the 2nd Medical Clinic of the University Hospital rechts der Isar at the Munich Technical University, the Association of Statutory Health Insurance Physicians in Bavaria (KVB) and Epigenomics AG, a molecular diagnostics company based in Berlin, Germany, and Seattle, WA, U.S.A. The total project budget is expected to sum up to around EUR 1.3 million. The project aims at developing a novel blood test that, in addition to colorectal cancer, can also detect pre-malignant precursors of the disease, so called adenomas and polyps. Compared to the currently recommended colonoscopy such an approach would be much more convenient for individuals undergoing colorectal cancer screening. A non-invasive blood test could thus complement currently available conventional prevention strategies including colonoscopy and thereby might significantly contribute to reducing mortality from colorectal cancer.

With approximately 149,000 and 73,000 newly diagnosed individuals each year in the U.S. and Germany, respectively, colorectal cancer is the most frequent gastrointestinal tumor. It is also second in cancer mortality each year accounting for about 50,000 and 30,000 cancer deaths in the U.S. and Germany respectively. The majority of colorectal cancers are diagnosed in advanced stages, limiting the chances for curative treatment. To improve prognosis for this disease the cancer must be detected in its earliest stages or even precancerous forms, i.e. adenomas or polyps. Thus, more than 90% of all patients could be cured if the cancer was diagnosed at an early, still localized stage. Removing the polyps could potentially even prevent the onset of disease. With the introduction of colonoscopy - typically in ten year intervals - as a screening modality for colorectal cancer in the US, Germany and other countries, the detection of early stage colorectal cancer and polyps was expected to improve considerably. However, only a minority of the eligible population complies with screening recommendations, hence limiting the success of this approach. A blood-based test detecting polyps and early stages of colorectal carcinoma could significantly improve patient's acceptance to colorectal cancer screening. An endoscopic examination with the option to remove polyps could be recommended particularly to those patients with a positive finding in the blood test.

Characteristic features in tumor development are inheritable modifications in gene regulation and gene expression, so called epigenetic changes. As these changes occur in the earliest stages of colorectal cancer development, they are ideally suited as diagnostic markers. Based on such an epigenetic marker, the DNA methylation marker mSEPT9, Epigenomics AG has already developed a blood test which can reliably detect colorectal cancer in the stages I to IV of disease progression.

The purpose of the current research project is to assess the suitability of the mSEPT9 test for the blood-based early detection of polyps and, if appropriate, to further optimize it for broader application, for example by combining the mSEPT9 marker with one or more additional markers.

"We are looking forward to investigate further applications of our biomarker in this ground-breaking alliance. After we have shown in thousands of patients that our mSEPT9 biomarker is able to detect colorectal cancer in a simple blood draw, we now have the chance to broaden the clinical utility of our test to the early detection of pre-malignant lesions", Geert Nygaard, CEO of Epigenomics, explained the motivation of the company to participate in the project.

While Epigenomics, based on its previous work and experience in biomarker R&D, can provide the mSEPT9 marker and additional candidate markers, KVB will manage the Network of contributing gastroenterologists to facilitate access to the study population. "Due to the electronic documentation of all colonoscopies in Bavaria, it will be possible to match the result of the blood test with the diagnostic findings of the colonoscopy. We already tested the necessary logistics in the participating private gastroenterology practices in a pilot study with three practices in Munich," said Dr. Axel Munte, Chairman of the KVB. To attract further participants to the study, the KVB would actively reach out to further gastroenterology practices in the greater Munich area during the next weeks, he continued.

Prof. Matthias Ebert of the 2nd Medical Clinic of the University Hospital rechts der Isar of the Munich Technical University is the clinical investigator and academic partner in this alliance. As clinical study director he will oversee the collection of clinical specimen within the network. Doubling as head of the molecular research laboratory at the University Hospital rechts der Isar he will also analyze markers developed by Epigenomics AG in a series of blinded training- and testing-set studies. "From a scientific and clinical point of view this research project is an innovative approach in cancer prevention. It focuses for the first time on screening for pre-malignant lesions, with the potential to catch the disease much earlier than current non- invasive screening methods", Prof. Ebert commented.

The alliance represents a novel form of collaboration which combines partners from industry, academia and public health care providers to work on innovative aspects in preventive oncology.

Your contacts:

Epigenomics AG Sen. Vice President Corporate Development Dr. Achim Plum Tel. +49-30-24345-368 E-Mail:

Klinikum rechts der Isar Press and Media Relations Tanja Schmidhofer Tel. +49-89-4140-2046 E-Mail:

KVB Communications Susanne Weckmann Tel. +49-89-57093-2192 E-Mail:

About Epigenomics

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 (

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

About University hospital rechts der Isar

With its approximately 4.000 employees the University Hospital rechts der Isar of the Munich Technical University attends to the care of the sick, the medical research and the teaching of medicine. Every year approximately 50.000 in-house patients and 170.000 out-patients benefit from medical attendance on the highest level. The hospital covers the entire spectrum of modern medicine with state-of-the-art-efficiency. Through the close cooperation between health care and research, the latest advances in medical techniques can be quickly integrated into patient treatment procedures. Since 2003 the University hospital rechts der Isar is a public-law institution of the Free State of Bavaria.

About KV Bavaria

Nationwide there are 17 Associations of Statutory Health Insurance Physicians in Germany. With its 24,000 members the Association of Statutory Health Insurance (SHI) Physicians in Bavaria (KVB) is the largest among them. The Association secures ambulant medical care in the territorial state of Bavaria with its 12 Million inhabitants. It also represents of its members - including all SHI physicians and psychotherapists, authorized hospital based physicians and employed doctors in medical care units (MVZ) - towards political institutions and health insurances.

end of announcement                               euro adhoc

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368

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