GTx, Gen-Probe form agreement to study prostate cancer assay

By Lisa Kerner

Erie, Pa., Jan. 31 - GTx, Inc. said it has entered into an exploratory collaboration with Gen-Probe, Inc. to evaluate the ability of Gen-Probe's research-stage PCA3 assay to detect high-grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate.

Clinical studies have shown that men with high grade PIN, diagnosed only by prostate biopsy, are at high risk for prostate cancer, according to a company press release.

Under terms of the agreement, GTx will provide Gen-Probe with urine samples from patients enrolled in GTx's clinical trials testing its selective estrogen receptor modulator Acapodene (toremifene citrate 20 mg) for the prevention of prostate cancer in men with high-grade PIN.

These trials include an ongoing large pivotal phase 3 trial in 1,260 men with high-grade PIN at more than 130 sites in the United States, Canada, Mexico and Argentina. Gen-Probe will evaluate the samples from this special patient cohort with its research-stage test for PCA3 gene expression. PCA3's pattern of expression may help identify a high-grade PIN subpopulation.

"A non-invasive, urine based test for high-grade PIN would facilitate the diagnosis of men who are at high risk for developing prostate cancer," GTx chief executive officer Mitchell Steiner said in the release.

"This agreement provides us access to high-quality clinical specimens that may help further establish the performance characteristics of our investigational PCA3 assay, including whether it has utility in detecting high-grade PIN and discriminating this condition from prostate cancer," Harry Rittenhouse, Gen-Probe's senior director for cancer research, said in the release.

There are 1.1 million men in the United States with biopsy-confirmed high-grade PIN. About 115,000 new cases are diagnosed annually. It is estimated that 15 million men in the United States unknowingly harbor the condition.

GTx, based in Memphis, is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for cancer and men's health. GTx's lead drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens, two essential classes of hormones.

Gen-Probe develops, manufactures and markets nucleic acid tests used primarily to diagnose human diseases and screen donated human blood. The company is based in San Diego.

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