GTx Incorporated announced top line results of its Phase 3 trial evaluating toremifene 20mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a premalignant lesion of the prostate. The randomized, three year study demonstrated that these patients (n=1590) are at high risk for prostate cancer, with 45.5% of men in the placebo group developing prostate cancer within three years. The primary endpoint of the study was the development of prostate cancer among men who had received at least one dose of study drug and had undergone at least one on-study prostate biopsy. Incidence of prostate cancer was lower in men receiving toremifene 20 mg compared to placebo but not statistically significantly different (p=0.385). A 10.2% relative risk reduction at three years was observed.
Toremifene is a selective estrogen receptor modulator (SERM) that is believed to selectively block estrogen receptors responsible for prostate cell proliferation.
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