Sep 14 2009
GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate.
The DSMB meets every six months to review unblinded safety data from the toremifene 20 mg Phase III high grade PIN clinical trial. Nearly 1,600 patients with high grade PIN have been enrolled in the three year clinical trial. The primary endpoint of the trial is a reduction in prostate cancer incidence. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration. The last patient will complete the Phase III high grade PIN clinical trial in the first quarter of 2010.
www.gtxinc.com
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