Clinical Study Proves Prognostic Power of Epigenomics’ Biomarker in Prostate Cancer

Wednesday, 05.04.2006, Berlin, Germany and Seattle, WA, USA, Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, today presented data showing that a test checking the methylation of a single gene, PITX2, can predict recurrence of prostate cancer in patients who have had their glands surgically removed.. The data from this study were presented at the 97th AACR Annual Meeting in Washington D.C., USA.

In a clinical study of tumor tissue taken from 605 prostate cancer patients, those who had a positive PITX2 methylation test were three times more likely to experience cancer recurrence than those who tested negative. Furthermore, the test predicted recurrence in all patient subgroups, including patients with organ-confined and non-organ-confined disease.

Cancer recurrence was defined in this study as a rise in prostate specific antigen (PSA) levels after surgery. Rising PSA after removal of the prostate indicates that the cancer is in the process of recurring.

“A methylation test like this could potentially help doctors decide which patients need additional treatment after surgery and those that probably don’t,” said Susan Cottrell, Ph.D., senior scientist at Epigenomics, Inc., in Seattle. “The test is based on underlying molecular changes involved in cancer development and this data is complementary to the clinical and anatomical information currently used to predict recurrence, such as tumor stage and Gleason score.”

The test will soon be validated in a multi-center trial for submission to the FDA. While this study analyzed prostatectomy samples, Epigenomics is expanding its research to see if the same results can be obtained from prostate biopsies.

“If the test is a strong enough predictor of a good prognosis at the stage of biopsy, men with indolent cancer may not need surgery or radiation at all,” Dr. Cottrell added. “We know many men have a non-aggressive form of prostate cancer, but because we currently have no way to identify those patients, only very few are treated with a ‘watchful waiting’ approach instead of surgery or radiation.”

The PITX2 gene is believed to play a role in regulation of hormones and Epigenomics earlier found that it could also help predict recurrence in breast cancer patients.

In this study, the researchers tested a total of six genetic markers − PITX2 plus five other methylated genes that were identified in tumor tissue taken from patients who recurred shortly after surgery. Hypermethylation of all six markers correlated with poor survival, but using PITX2 alone, the researchers found they could develop a methylation score that defined a good prognosis (with 94 percent PSA-free survival 10 years after surgery) and a poor prognosis group (with 70 percent survival).


About Epigenomics
Epigenomics is a molecular diagnostics 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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Kurt Berlin

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Epigenomics AG

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