GTx, Inc. this weekend presented results of the Capesaris™ (GTx-758) proof of concept pharmacokinetic-pharmacodynamic (PK/PD) clinical trial treating men with advanced prostate cancer, at the Annual Meeting of the Society of Urologic Oncology. Capesaris is a novel oral selective estrogen receptor alpha agonist which GTx is developing for first line treatment of advanced prostate cancer.

“As Capesaris advances from proof of concept into clinical trials in men with advanced prostate cancer, it is emerging as a promising drug candidate which represents a new approach to androgen deprivation therapy,” said Thomas Keane, M.D., Chairman and Professor of Urology at the Medical University of South Carolina. “Because of the mechanism of action through the estrogen receptor, Capesaris has the potential to suppress testosterone to castrate levels without previously documented problems of ADT such as bone loss and hot flashes.

In the Phase II PK/PD clinical trial, sixty healthy male volunteers (ages 18-40) were randomized to one of three Capesaris treatment arms, 600mg, 1000mg, or 1500mg. Subject compliance was determined by statistical comparison of trough Capesaris plasma concentrations. Subjects received oral Capesaris for 56