GTX'S DEVELOPMENT OF ACAPODENE ON TRACK

GTx announced that a per-protocol interim safety review by an independent data safety monitoring board (DSMB) recommended that the company continue its two pivotal Phase III clinical trials of Acapodene (toremifene citrate). The DSMB meets every six months to review unblinded safety data from the two pivotal Phase III clinical trials.

GTx is developing Acapodene in two separate indications. One Phase III clinical trial is evaluating Acapodene 80 mg for the treatment of multiple side effects of androgen deprivation therapy for prostate cancer. Approximately 1,400 patients have been enrolled in the trial, which is being conducted under a special protocol assessment (SPA) with the FDA. The primary endpoint of the trial is a reduction in fractures. Other endpoints include improvements in bone mineral density, hot flashes, lipid profiles and gynecomastia.

A separate pivotal Phase III clinical trial is evaluating Acapodene 20 mg for the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia. Nearly 1,500 patients have been enrolled in the trial, which is also being conducted under an SPA with the FDA. The endpoint of the trial is a reduction in prostate cancer incidence. GTx expects to conduct an interim efficacy analysis between the fourth quarter of 2007 and the first quarter of 2008. If the statistical parameters are achieved, GTx will proceed with filing a new drug application.