GTx/Ipsen's toremifene meets key endpoints
US firm GTx Inc says that Phase III clinical data for toremifene citrate 80mg, the company's investigational therapy for the treatment of multiple side effects of androgen deprivation therapy for advanced prostate cancer. Results show that the drug reduced vertebral fractures and met other key endpoints, including bone mineral density, lipid profiles, and gynecomastia.
Based on these findings, GTx expects to file a New Drug Application with the US Food and Drug Administration by the summer of 2008. In addition, it plans to present the full data set at an upcoming medical meeting. The news sent the firm's share price rocketing 63% to $21 i premarket trading on February 25.
Meantime, France's Ipsen, which licensed toremifine (for which it uses the trade name Acapodene) from GTx in September 2006, has said that, on the basis of these Phase III study results, it intends to file for European Union approval before the end of this year.
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