FDAnews
www.fdanews.com/articles/86543-gtx-attains-enrollment-goal-for-pin-trial

GTX ATTAINS ENROLLMENT GOAL FOR PIN TRIAL

May 3, 2006

GTx has attained its enrollment goal for a pivotal Phase III clinical trial of Acapodene for the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia, or PIN. This is the largest-ever prospective study of high-grade PIN, with more than 1,260 men participating in the placebo-controlled, double blind clinical trial.

Patients in the clinical trial will be randomized to receive daily for three years either Acapodene in a 20 mg dose or placebo. The primary endpoint is a reduction in prostate cancer incidence.