Epigenomics Successfully Completes Biomarker Validation Study for Prostate Cancer Classification Test

- Product Forms Foundation of Company’s Tissue-Based Product Pipeline -

Wednesday, 04.01.2006, Berlin, Germany and Seattle, WA, USA, Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, announced today the successful completion of a 605 patient study validating three of its proprietary DNA methylation markers as clinically useful indicators of prostate cancer aggressiveness. Epigenomics, which during 2005 prepared to initiate its own development of molecular pathology products, also announced the development of the test as its own product, following Roche Diagnostics’ decision to discontinue the collaborative development of the prostate cancer molecular classification test and to not maintain their option rights to an exclusive license.

The decision to take the prostate cancer molecular classification test into development, is fully aligned with Epigenomics’ strategy to focus its own efforts on tissue-based molecular pathology products for high margin specialty applications in oncology, while partnering high-volume cancer screening products with global leaders in centralized diagnostics.

The present study validated three DNA methylation markers on 605 paraffin-embedded prostate cancer samples. They were obtained during surgery for radical removal of the prostate between 1993 and 2000 at three prominent U.S.-based centers. The three markers are statistically significant in separating a group of patients with good prognosis from those of a poor prognosis group, patients within which have an about three times higher likelihood of cancer recurrence. Moreover, two markers add clinically relevant information clearly beyond that which is generated by currently available prognostic factors such as Gleason score, tumour stage and pre-surgery levels of prostate specific antigen (PSA). In particular, treatment planning and prognosis is most uncertain for patients with an intermediate Gleason score of 7, for which the markers identified a large subgroup with very good prognosis.

The American Cancer Society expects over 230,000 new cases of prostate cancer in the U.S. in 2005, and around 30,000 men will die of this disease. Surgical removal of the prostate is performed as potentially curative treatment in around 40% of patients, despite which the disease recurs in about one in seven cases. Epigenomics’ markers have been developed on surgical samples and identify patients with a bad prognosis that are possibly under-treated but may benefit from adjuvant treatment after surgery. In addition, since the markers have the capability to identify a group with very good prognosis, they can and will be further developed for diagnostic needle biopsy samples, with the intention to identify patients who could be spared radical prostate surgery.

“Interestingly, the marker which performed best in this study was our proprietary PITX2 biomarker, which was initially identified for its prognostic value in breast cancer. Not only have our workflow and markers performed very well in prostate cancer, but this study also greatly solidifies our confidence in PITX2 as a general prognostic marker - despite the reported set-back in our most recent breast cancer study. These data support our optimism in continuing development of both the prostate and breast cancer molecular classification tests, as the studies mutually corroborate each other”, commented Dr. Kurt Berlin, CSO of Epigenomics. “There could be no better support for the biological relevance of a biomarker than its functionality across different indications,” he added.

Thomas M. Wheeler, MD, Professor of Pathology at the Baylor College of Medicine, who was involved in the study, stated: “The inclusion of such molecular markers to the routine could be of great help when clinicians and patients need to decide on further treatment strategies after surgery. Furthermore, if the markers show to be prognostic at the diagnostic biopsy stage, they could lead to a profound change in prostate cancer management.”

John Corman, MD, from the Department of Urology at the Virginia Mason Clinical Center said: “With immunotherapy, targeted therapy, and effective cytotoxic therapy, the role of adjuvant treatment for prostate cancer is becoming increasingly clear. A prognostic tool based on the identified methylation markers would be extremely valuable for determining who would benefit most from such treatment.”

About Epigenomics
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products in cancer. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our website at www.epigenomics.com.

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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.

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Hong Thieu

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Epigenomics AG

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