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Phase 3 Clinical Development of Toremifene Continues Following Planned Safety Review

MEMPHIS, Tenn., Jan. 19 /PRNewswire-FirstCall/ -- GTx, Inc. (NASDAQ:GTXI) , the Men's Health Biotech Company, today announced that a per protocol interim safety review by an independent Drug Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of ACAPODENE(R) (toremifene citrate). The DSMB meets regularly every six months to review unblinded safety data from the two pivotal Phase III clinical trials. GTx is evaluating the use of ACAPODENE in an 80mg dose for the treatment of multiple side effects of androgen deprivation therapy (ADT) in men with advanced prostate cancer, and of ACAPODENE 20mg dose for the prevention of prostate cancer in high risk men.

In the first study, 1,388 prostate cancer patients on ADT at approximately 150 clinical centers in the United States and Mexico were randomized to receive daily an oral, 80mg dose of ACAPODENE or placebo. The primary endpoint of the trial is a reduction in vertebral fractures. Secondary endpoints include improvements in bone mineral density (BMD), lipid profile, gynecomastia, and hot flashes. The two-year trial is being conducted under a Special Protocol Assessment (SPA) with the United States Food & Drug Administration (FDA). In the second half of 2005, GTx completed enrollment of the trial and conducted an interim analysis of BMD in the first 200 patients to finish one year of treatment. The interim analysis was highly statistically significant with ACAPODENE 80mg therapy resulting in BMD increases versus placebo of +2.3% in the lumbar spine (p In the second study, ACAPODENE 20mg is being evaluated under a SPA with the FDA for the prevention of prostate cancer in men with the premalignant lesion called high grade prostatic intraepithelial neoplasia (PIN). 1,260 men are being randomized at more than 130 sites in the United States, Canada, Mexico and Argentina to receive daily an oral, 20mg dose of ACAPODENE or placebo. The primary endpoint of the trial is the reduction of prostate cancer incidence. Enrollment of the trial is expected to be completed in the first quarter of 2006.

"The DSMB reviewed safety data of more than 2,000 patients enrolled in our two Phase III trials and recommended that GTx continue with the trials as planned. This welcome news, along with the efficacy demonstrated recently in the interim analysis of BMD in our ADT trial, reduces the risk in ACAPODENE's clinical development and improves the prospects that we will be able to submit these product candidates for marketing approval," said Mitchell Steiner, MD, Chief Executive Officer of GTx.

Source: GTx, Inc.

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