Results show that toremifene citrate 80mg reduced vertebral fractures and met other key endpoints, including bone mineral density, lipid profiles, and gynecomastia. Based on these findings, GTx plans to file a new drug application with the FDA by the summer of 2008.
Matthew Smith, principal investigator of the Phase III ADT clinical trial, said: “The toremifene citrate 80mg Phase III ADT clinical trial is the first fracture prevention study in men receiving ADT for prostate cancer. The study confirms that men receiving ADT are at high risk for fractures.”