One of the determinants of a patient’s risk for developing prostate cancer, independent of age, race and family history, is the presence of the precancerous lesion called high grade prostatic intraepithelial neoplasia (PIN). The threat that men with high grade PIN will develop prostate cancer within three years is as high as 50% and beyond five years rises to 80%. With no approved therapies for high grade PIN today, the standard of care for these patients is to continue to monitor the progression of high grade PIN to cancer through serial prostate biopsies.

GTx is conducting a pivotal Phase III clinical trial evaluating ACAPODENE® (toremifene citrate) 20 mg for the prevention of prostate cancer in men with high grade PIN. 1,590 patients with high grade PIN are enrolled in the trial, which is being conducted under a Special Protocol Assessment with the United States Food & Drug Administration (FDA). The primary endpoint of the trial is a reduction in the incidence of prostate cancer.