Alliance to Develop Test for Prostate Neoplasia

(Memphis, TN, USA), and diaDexus, Inc. (Santa Clara, CA, USA), will collaborate on developing a commercial assay for blood or urine to detect high-grade prostatic intraepithelial neoplasia (PIN) and/or prostate cancer.

GTx will provide clinical samples from its completed phase IIb clinical trial that evaluated Acapodene (toremifene citrate) tablets for reducing the incidence of prostate cancer in men with high-grade PIN, a malignant lesion with the potential to progress to cancer. Acapodene is a nonsteroidal selective estrogen receptor modulator (SERM) that appears to block the estrogen's unwanted actions on the prostate. The information resulting from this collaboration will be evaluated by diaDexus for the purpose of developing a commercial assay to detect high-grade PIN. Unfortunately, high-grade PIN is currently detected only when men are biopsied.

In the phase IIb trial that evaluated Acapodene, placebo patients had a 31.2% accumulated rate of prostate cancer, while a 20% reduction was seen in the accumulated rate of prostate cancer incidence for patients taking the drug. There was a 46% reduction in prostate cancer incidence for those men who were on Adapodene for the entire year. The placebo patients and the treated patients had similar Gleason scores, indicating that Acapodene is not selecting out more-aggressive tumors. GTx has licensed the right from Orion Corporation (Helsinki, Finland) to develop, market, and distribute toremifene citrate, the active ingredient of Acapodene tablets, worldwide for the prevention and treatment of prostate cancer.

"The development of high-grade PIN could be a component in the recognition and treatment of this disease,” said Mitchell Steiner, M.D., CEO of GTx. "Together with diaDexus, one of the first companies to recognize the potential of genomics to generate valuable diagnostic tests, we have the opportunity to develop products that could have a significant impact in the prevention of prostate cancer.”




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DiaDexus