Epigenomics Reports Positive Interim Results in Prostate Cancer Clinical Study

- Clinical study of over 500 patient samples well on track for
completion in Q4 2008
- Interim analysis representing approximately half of the cases
demonstrates statistical significance for primary endpoint of
prostate cancer prognosis (probability of recurrence)
- PITX2 biomarker classifies patients into groups at high and low
risk for relapse following surgery

Berlin, Germany and Seattle, WA, USA, September 8, 2008 - Epigenomics
AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics
company developing tests based on DNA methylation, today reported
positive interim results from an ongoing prostate cancer trial.

"Upon completion of testing about half of the patient samples for
PITX2 methylation we have conducted a scheduled interim analysis",
commented Dr. Gunter Weiss, Product Development Manager at
Epigenomics. "This analysis shows that we are on a very promising
path to show that PITX2 methylation is indeed a strong, independent
prognostic marker. The Interim analysis demonstrated statistical
significance for the primary endpoint," Dr. Weiss added.

The clinical study is analyzing paraffin embedded tissue samples from
over 500 prostate cancer patients who had undergone radical
prostatectomy, collected at four major clinical centers in Europe and
the USA with the, objective of validating the prognostic utility of
Epigenomics' proprietary biomarker, PITX2. The primary endpoint of
the study is to evaluate the methylation status of the PITX2 gene as
an independent prognostic biomarker indicative of the risk prostate
cancer recurrance in patients following removal of the entire
prostate, known as radical prostatectomy. The study is also analyzing
whether measurement of PITX2 methylation adds clinical information to
established prognostic parameters such as Gleason score, tumor
staging, pre-surgical PSA levels and surgical margin status. The
study is expected to validate the clinical utility of PITX2 for
prostate cancer prognosis first established in a 2006 clinical study
on 605 prostatectomy tissue samples. The biomarker is extremely
robust and may be measured using an Affymetrix microarray platform,
as well as other assay technologies suitable for routine clinical
use, creating maximum flexibility for routine clinical use and
commercialization.

Epigenomics plans to complete the clinical study by the end of the
third quarter and data analysis should be finalized in October.
Epigenomics will analyze the study results with its clinical
collaborators at Baylor College of Medicine, Houston Texas, USA and
Erasmus MC, Rotterdam, The Netherlands, Duke University, Durham North
Carolina, USA, and the VA Medical Center at Durham, North Carolina,
USA in a joint meeting scheduled for early October 2008. Headline
results from the completed study are expected to be released shortly
thereafter and are planned for publication in a peer reviewed journal
in due course.

"Since Epigenomics is focused primarily on its body-fluid-based early
cancer detection programs in colorectal, lung and prostate cancers,
we do not intend to manufacture and market the assay ourselves"
stated Geert Nygaard, Chief Executive Officer of Epigenomics.
"Nevertheless, we want to make the test available to clinicians and
patients as soon as possible. To this end we are exploring several
opportunities to partner PITX2, which has potential applications
beyond prostate cancer prognosis, such as in breast cancer.
Commercial options include licensing the biomarker and a suitable
assay technology to reference laboratories, the launch of RUO
products for clinical research in Europe, and potentially the
transfer of the fully developed assay system to suitable partners for
regulatory submission and commercialization as an IVD product" Geert
Nygaard added.
About Epigenomics' Prostate Cancer Molecular Classification 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 molecular classification test based on the DNA
methylation biomarker PITX2 that will provide physicians and patients
with prognostic information on disease recurrence by identifying
those prostatectomy patients at increased risk.
Currently, prognostic information is mainly derived from clinical and
histopathological parameters, such as tumor size, Gleason score and
pre-surgery PSA levels. In a study published at the 2006 annual AACR
meeting, Epigenomics has shown that DNA methylation of PITX2
constitutes a strong prognostic marker for outcome prediction after
radical prostatectomy. In this study, PITX2 separated
post-prostatectomy cancer patients into two distinct groups: Those
with a high likelihood of cancer recurrence and those with a low
likelihood of cancer recurrence. Furthermore, PITX2 methylation added
significant information to established clinical parameters.
Remarkably, the PITX2 biomarker was able to predict outcome in
patients diagnosed with Gleason 7, for which reliable prognosis based
on conventional parameters is particularly difficult. 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.
About Epigenomics AG
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 Septin 9 for
the early detection of colorectal cancer in a simple blood sample
demonstrated continuously highest performance in multiple clinical
studies with in total more than 3,500 individuals tested.

For development and global commercialization as in vitro diagnostic
test kits, Epigenomics pursues a non-exclusive partnering strategy
with diagnostics industry companies. As a first strategic partner,
Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights
to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer.
Epigenomics also aims at giving patients and doctors early access to
these biomarkers through reference laboratory testing services. As a
first reference laboratory partner, Quest Diagnostics Inc., the
leading provider of diagnostic testing, information and services,
obtained the license to commercialize a laboratory-developed test
(LDT) for Septin 9 in the U.S.

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.

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Disclaimer
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.

Contact:

Epigenomics AG
Oliver Schacht, PhD
CFO
Phone: +49 (0) 30-24345-331
Email: oliver.schacht@epigenomics.com
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