DSMB RECOMMENDS GTX CONTINUE ACAPODENE TRIALS

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

GTx is developing Acapodene for two separate indications in men. The company is conducting one trial evaluating Acapodene 80 mg for the treatment of multiple side effects of androgen deprivation therapy for prostate cancer. Approximately 1,400 patients are participating 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. In December 2005, GTx conducted a planned interim analysis of bone mineral density in the first 197 patients to complete a full year of treatment. In each of three measurements (lumbar spine, hip and femoral neck), statistically significant positive changes were observed in patients on Acapodene compared with patients on placebo, who on average lost bone density.

The company is conducting a separate Phase III trial evaluating Acapodene 20 mg for the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia. More than 1,340 patients with are enrolled in the trial, which is being conducted under a 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, the company will file a new drug application.