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news.GTx has announced that following a planned safety review, an independent data safety monitoring board has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia.
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The data safety monitoring board meets every six months to review unblinded safety data from the toremifene Phase III clinical trials.
Nearly 1,600 patients with high grade prostatic intraepithelial neoplasia (PIN) have been enrolled in the toremifene 20mg Phase III high grade PIN clinical trial. The primary endpoint of the trial is a reduction in prostate cancer incidence. GTx anticipates conducting an efficacy analysis of toremifene 20mg in summer 2009.
Mitchell Steiner, CEO of GTx, said: “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.”