Epigenomics AG Reports Successful Completion and Positive Results from Prostate Cancer Clinical Study

20-10-2008: Epigenomics AG reported positive final results from its prognostic prostate cancer study.

“After testing all patient samples for methylation in the PITX2 gene we have successfully conducted our final analysis”, commented Dr. Gunter Weiss, Vice President Product Development at Epigenomics. “This analysis shows that PITX2 gene methylation is indeed a strong, independent prognostic marker that can help guide physicians to determine a patient’s risk for relapse. The analysis demonstrated statistical significance for all study endpoints”, Dr. Weiss added.

The clinical study successfully analyzed paraffin embedded tissue samples from 476 prostate cancer patients collected at four major clinical centers in Europe and the USA who had undergone radical prostatectomy, with the objective of validating the prognostic utility of Epigenomics’ proprietary biomarker, PITX2. The primary endpoint of the study was to evaluate the methylation status of the PITX2 gene as an independent prognostic biomarker indicative of the risk of prostate cancer biochemical recurrence in patients following removal of the entire prostate, known as radical prostatectomy. This primary endpoint of the study was met by the statistically significant demonstration that patients with elevated PITX2 gene methylation level had a threefold higher risk of relapse following prostatectomy compared to patients with low PITX2 methylation (hazard ratio 3.0; p<0.00005).

As secondary endpoints, the study also analyzed whether measurement of PITX2 methylation adds clinical information to established prognostic parameters such as age, Gleason Score, tumor staging, pre-surgical PSA levels and surgical margin status. In each of the pair wise comparisons of PITX2 with one of these established parameters, high PITX2 gene methylation was an independent prognostic factor indicating more than double the risk compared to patients with low PITX2 gene methylation (hazard ratios > 2.3; p<0.0001). In the group of patients with an intermediate Gleason Score of 7, which present difficult decisions for doctors and patients due to difficulty in determining their prognosis, the PITX2 marker was able to discriminate patients into those with a high and low risk of disease recurrence (hazard ratio 2.0; p=0.005). PITX2 gene methylation remained a statistically significant independent prognostic factor even when it was combined with several established parameters (hazard ratio 1.9; p=0.004) demonstrating its added value in guiding patient management.

The study confirmed the clinical utility of the PITX2 biomarker for prostate cancer prognosis, first established in a 2006 clinical study on 605 prostatectomy tissue samples using real time PCR. In the current study the PITX2 gene methylation was measured reliably using an Affymetrix GeneChip™ platform, confirming the robustness of the marker across various assay technologies suitable for routine laboratory use.

Following these successful results of its clinical study Epigenomics intends to make the PITX2 assay available to clinicians and patients as soon as possible and is exploring several opportunities to commercialize PITX2.