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Phase 3 Trial Investigating Toremifene To Prevent Prostate Cancer Initiated

MEMPHIS, Tenn., Jan. 26 /PRNewswire-FirstCall/ -- GTx, Inc. (Nasdaq: GTXI - News), a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for serious men's health conditions, today announced that the company has initiated a pivotal Phase III clinical trial for Acapodene for the prevention of prostate cancer in high risk men.

The company had an investigators meeting January 21-22, 2005, with approximately 100 U.S. clinical sites for its Phase III PIN trial. The pivotal Phase III trial is a double blind, placebo controlled, multicenter study. Patients with high grade prostatic intraepithelial neoplasia (PIN), the precancerous lesion in prostate cancer, will be randomized into two treatment groups: 20 mg toremifene or placebo. The primary endpoint of the clinical trial is the incidence of prostate cancer.

GTx has received initial comments from the Food and Drug Administration (FDA) on the preliminary review of the Special Protocol Assessment (SPA). As part of the SPA process, GTx plans to address these comments and resubmit the revised SPA.

"We are excited about the initiation of GTx's pivotal Phase III trial for Acapodene in men who are at high risk for prostate cancer," stated Mitchell Steiner, M.D., Vice Chairman and CEO of GTx. "Providing a prevention option for men who are at high risk for this premalignant disease is a top priority as there are no treatment options currently available for these patients."

About Acapodene
Acapodene is a nonsteroidal SERM, a small molecule that binds and selectively modulates the estrogen receptor. SERMs have been shown to block estrogen receptors in the prostate. GTx has licensed the right to develop, market and distribute toremifene citrate, the active ingredient of Acapodene tablets, in all indications in the United States.

About High Grade PIN
It has been well established that patients with high grade PIN are at high risk for developing prostate cancer. PIN is detected in approximately 9% of the patients who undergo prostate biopsies. Prostate cancer is found in approximately 30-70% of high grade PIN patients within one year of diagnosis, and in 45-80% of high grade PIN patients within five years.

Source: GTx, Inc.

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