EANS-Adhoc: Ad Hoc Announcement Pursuant to §15 WpHG (German Securities Trading Act) Epigenomics AG Releases Preliminary PRESEPT Study Data

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ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro
adhoc with the aim of a Europe-wide distribution. The issuer is solely
responsible for the content of this announcement.
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Company Information/Molecular diagnostics

15.01.2010

Berlin, January 15, 2010 - Epigenomics AG (ISIN: DE000A0BVT96), a
cancer molecular diagnostics company, informs on preliminary data
from the prospective multi-center clinical PRESEPT Colorectal Cancer
Screening Study (clinicaltrials.gov; identifier: NCT00855348)
sponsored by the company. The primary study objective is to
demonstrate that the Septin9 biomarker satisfies the requirements for
noninvasive screening tests set forth in current joint guidelines by
the American Cancer Society, the US Multi-Society Task Force on
Colorectal Cancer, and the American College of Radiology.(Ref. 1) The
results of this preliminary data analysis were reported by Timothy R.
Church, Ph.D., University of Minnesota, Minneapolis, MN, U.S.A.,
Principle Investigator of the PRESEPT Study on behalf of the PRESEPT
Clinical Study Steering Committee, chaired by Professor David
Ransohoff, M.D. University of North Carolina School of Medicine,
Chapel Hill, NC, U.S.A.

This preliminary analysis indicates that two of the three testing
laboratories performing the Septin9 testing on blood plasma samples
from PRESEPT Study subjects achieved cancer detection rates of 62.5%
each, that were within expectations from previously published
clinical studies (Refs 2-4) taking into account the higher proportion
of early stage cancers in the PRESEPT Study cohort. The third
laboratory reported a cancer detection rate of 28% deviating from
findings in the other PRESEPT Study testing laboratories and all
previous studies. The overall cancer detection rate based on results
from all three laboratories combined added up to 50%. Specificity as
measured on colonoscopy verified subjects without any apparent colon
disease was at 91% confirming the high specificity rates seen in
previous clinical studies.

The Clinical Study Steering Committee, which includes the Principal
Investigator representing the independent University of Minnesota
biostatistics team, charged with analyzing the PRESEPT data, intends
to conduct a failure investigation to identify the potential causes
for the outlier results observed in the one of the laboratory before
reporting final results of the study, that may deviate from the
reported preliminary results of the study.

Between June 2008 and December 2009, 7,914 average risk, CRC
screening eligible subjects were enrolled into the PRESEPT Study at
32 clinical sites, of which 22 sites were located in the U.S. and 10
sites were located in Germany. This study population contained 50
confirmed cases of previously unsuspected colorectal cancer that were
identified by screening colonoscopies performed on all study
participants.

Final and detailed study results will be presented at upcoming
medical conferences and will also be submitted to a scientific
journal for peer-review and publication once available.

End of Ad Hoc

Further information

Conference Calls

Epigenomics´ management scheduled conference calls for Monday,
January 18, 2010 at 15:00 CET (German language) and 17:00 CET/11:00
am EST (English language) to inform on the preliminary results and
potential further actions as well as answering questions from
investors and media. Dial-in details will be published on Epigenomics
website www.epigenomics.com prior to the calls.

References

1. Levin B, et al., Screening and surveillance for the early
detection of colorectal cancer and adenomatous polyps, 2008: a
joint guideline from the American Cancer Society, the US
Multi-Society Task Force on Colorectal Cancer, and the American
College of Radiology. Gastroenterology 2008;134(5):1570-95. 2.
Lofton-Day C, et al. DNA methylation biomarkers for blood-based
colorectal cancer screening. Clin Chem. 2008;54(2):414-23. 3.
Grützmann R, et al. Sensitive detection of colorectal cancer in
peripheral blood by mSEPT9 DNA methylation assay. PLoS One.
2008;3(11):e3759. 4. deVos T, et al. Circulating methylated SEPT9 DNA
in plasma is a biomarker for colorectal cancer. Clin Chem.
2009;55(7):1337-46.

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
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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, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade