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’s 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.
Interim analysis representing approximately half of the cases demonstrates statistical significance for primary endpoint of prostate cancer prognosis (probability of recurrence).
According to the company, 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 2008.
Gunter Weiss, product development manager at Epigenomics, said: “Upon completion of testing about half of the patient samples for PITX2 methylation we have conducted a scheduled interim analysis. 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.”