GTx: Phase III Development of Toremifene on Course

Following a scheduled safety review, an independent data safety monitoring board has recommended that GTx continue its pivotal Phase III trial evaluating toremifene 20 mg as a prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia (PIN).

The trial’s primary endpoint is a reduction of prostate cancer incidence. It has enrolled nearly 1,600 patients with high-grade PIN, a microscopic lesion in the prostate that is believed to be a precursor to prostate cancer.

The study is being conducted under a special protocol assessment with the FDA. The company said it expects to conduct an efficacy analysis of the drug in the summer of 2009.