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Data Safety Monitoring Board Recommends Continuing Phase 3 Trial of Toremifene
“The DSMB has now reviewed safety data of the nearly 3,000 patients enrolled in the toremifene Phase III 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 III 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.