United Press International - Health Business - GTx begins trial of prostate-cancer drug
GTx begins trial of prostate-cancer drug

MEMPHIS, April 21 (UPI) — GTx said Friday it is initiating a phase 3b trial of Acapodene in men undergoing androgen deprivation therapy for prostate cancer.

Prostate-cancer patients who have completed the full two-year treatment course in the pivotal phase 3 trial of Acapodene will be eligible to participate in the phase 3b trial for an additional year, GTx said. The aim of the phase 3b trial is to collect additional data about fractures and safety. Acapodene is intended as a treatment of the side effects of androgen deprivation therapy for advanced prostate cancer.

The company noted that the phase 3b study is considered a separate study and will not affect its anticipated timeline for submitting the new drug application for Acapodene. The phase 3b study also will not affect the expected completion date of the phase 3 pivotal trial in the second half of 2007.

The phase 3 trial, which is determining whether Acapodene reduces vertebral fractures and improves bone mineral density, completed enrollment in 2005. An interim analysis showed a positive change in bone mineral density in patients treated with Acapodene compared to the placebo group.