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: achim.plum@epigenomics.com

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

KVB
Communications
Susanne Weckmann
Tel. +49-89-57093-2192
E-Mail: presse@kbv.de

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 (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.

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
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Epigenomics AG

Dr. Achim Plum

Sen. VP Corporate Development

Tel: +49 30 24345 368

achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
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München / free trade