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news.GTx has reported positive Phase III data for toremifene citrate 80mg, the company's investigational therapy for the treatment of multiple side effects of androgen deprivation therapy or ADT for advanced prostate cancer.
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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.”