The DSMB meets regularly every six months to review unblinded safety data from the two Phase III clinical trials.
“The DSMB reviewed safety data of the approximately 3,000 patients enrolled in the two Phase III Acapodene clinical trials and recommended that GTx continue with the trials as planned under the existing protocols,” said Mitchell S. Steiner, MD, CEO of GTx.
GTx is developing the drug in two Phase III clinical trials for two separate indications in men. One trial will evaluate Acapodene 80 mg for the treatment of multiple side effects of androgen deprivation therapy (ADT) for prostate cancer. The other will evaluating Acapodene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN).
GTx anticipates that it will release the top line results from the phase III trials in the first quarter of 2008.