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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

Berlin and Munich, Germany, May 26, 2009 (euro adhoc) -

  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
research/new product/molecular diagnostics
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

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
Düsseldorf / free trade
München / free trade

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