GTx, Inc. 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-3 clinical trial evaluating Toremifene 20 mg for the prevention of prostate cancer in men with high grade Prostatic Intraepithelial Neoplasia (PIN). The DSMB meets every six months to review unblinded safety data from the Toremifene phase-3 clinical trials.
"The DSMB has now reviewed safety data of the nearly 3,000 patients enrolled in the toremifene phase-3 clinical trials, with some patients on drug for as long as three years," said Mitchell S Steiner, MD, chief executive officer of GTx. "We are pleased that the DSMB has recommended we continue this pivotal trial of Toremifene 20 mg as planned. We look forward to the results of this important trial, as there remains a large need for therapies that prevent prostate cancer, particularly in patients with high grade PIN who are at high risk for developing the disease."
Nearly 1,600 patients with high grade PIN have been enrolled in the Toremifene 20 mg phase-3 high grade PIN 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. GTx anticipates conducting an efficacy analysis of toremifene 20 mg in the summer of 2009.
GTx, Inc., headquartered in Memphis, Tennessee, is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions.