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EANS-News: Epigenomics AG Presents Clinical Data from Prostate Cancer Prognosis Study at ASCO

Geschrieben am 29-05-2009

Biomarker mPITX2 for prostate cancer prognostic application
successfully validated
First clinical laboratory in Germany to
start offering mPITX2 testing service


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

Press release, Berlin, Germany and Seattle, WA, USA, May 29, 2009
(euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and
commercialization of products for cancer detection based on DNA
methylation, will present clinical data from its study validating the
mPITX2 biomarker in a prognostic setting in prostate cancer at this
year's ASCO (American Society of Clinical Oncology) conference in
Orlando, Florida, USA. The data will be presented by Esmeralda
Heiden, M.D., Ph.D., Pathologist at Epigenomics, on May 31, 2009 in
a poster presentation titled "PITX2 methylation and biochemical
recurrence in postradical prostatectomy prostate cancer patients".

The mPITX2 biomarker is at the core of Epigenomics' prostate cancer
prognosis test that indicates the risk of early disease recurrence
following a surgical removal of the cancerous prostate. Epigenomics
has successfully validated the biomarker using a fully developed test
system for this application.

"Assessing PITX2 methylation could provide a valuable means to better
define prostate cancer risk groups and thus aid in selection of
patients for whom adjuvant and/or early salvage therapy may be
warranted," commented Lionel Bañez, M.D., one of the clinical
collaborators in the validation study. "Furthermore, PITX2
methylation status could also be used in the rational design of
clinical trials and improve testing of new therapeutic regimens." Dr.
Bañez is affiliated with the Division of Urologic Surgery and the
Duke Prostate Center at Duke University Medical Center in Durham,
North Carolina. Further clinical sites collaborating in this
international multicenter study also included the Baylor College of
Medicine, Houston, Texas, USA, the Erasmus Medical Center, Rotterdam,
The Netherlands, the VA Medical Center at Durham, North Carolina,
USA, and the University Hospital Erlangen, Erlangen, Germany.

The pathology laboratory of Prof. Dr. Arndt Hartmann at the
University Hospital Erlangen in Germany is the first of a selected
number of laboratories that Epigenomics has now enabled under its
"Early Access Program" to offer mPITX2 testing services in Germany.
Prof. Dr. Arndt Hartmann, Director of the Institute of Pathology at
the University Hospital in Erlangen commented the study results and
why his lab will start offering mPITX2 testing: "Technically, this
has been a perfect study. For all but a single patient a valid PITX2
measurement has been provided. The technology is mature and ready for
release."

2009 ASCO Annual Meeting Presentation Details

The poster titled "PITX2 methylation and biochemical recurrence in
postradical prostatectomy prostate cancer patients" will be presented
by Esmeralda Heiden, MD, PhD, in the Session Genitourinary Cancer on
May 31, 2009, 2 -6 pm on Level 2 in West Hall C at the 2009 ASCO
Annual Meeting, May 29 to June 2, 2009, in Orlando FL, U.S.A.

About Epigenomics' Prostate Cancer Prognosis Test

Prostate cancer is the most common cancer in American and European
men. With an annual incidence of approximately 470,000 cases in the
US and Europe, one in six men will be diagnosed with prostate cancer
in his lifetime and about 100,000 men will die from the disease every
year. Surgical removal of the prostate (radical prostatectomy) is
performed as potentially curative treatment in about 40% of patients
diagnosed with prostate cancer. Nevertheless, the disease recurs in
about one in seven prostatectomy patients. However, the difficulty
clinicians have is that even with the use of current prognostic
parameters, there still remains considerable uncertainty concerning
which patients will eventually relapse. Epigenomics is developing a
prostate cancer prognosis test based on the DNA methylation biomarker
PITX2 (mPITX2) that may provide physicians and patients with
prognostic information by identifying those prostatectomy patients at
increased risk for early disease recurrence. The demand among
physicians for such a molecular diagnostic test is high, since it
identifies patients with a poor prognosis that are possibly
under-treated. Epigenomics is in the process of making mPITX2
available at selected clinical centers in Europe within an "Early
Access Program" for this biomarker. For broad commercialization,
Epigenomics intends to partner the test with suitable players in the
diagnostics industry.

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.

Epigenomics legal disclaimers. 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.

The information contained in this communication does not constitute
nor imply an offer to sell or transfer any product, and no product
based on this technology is currently available for sale in the
United States. The analytical and clinical performance
characteristics of any product based on this technology which may be
sold at some future time in the U.S. have not been established.


end of announcement euro adhoc
--------------------------------------------------------------------------------


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
Düsseldorf / free trade
München / free trade


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