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news.Theratechnologies has announced that the last patient has completed 26 weeks of treatment in the confirmatory Phase III trial testing tesamorelin in HIV-associated lipodystrophy.
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The company expects to present top-line results of this confirmatory Phase III trial by the end of the first half of 2008. The trial is a 400-patient, multi-center, double-blind, randomized, placebo-controlled study conducted in 48 centers in North America and Europe. It is designed to confirm the results of the first Phase III trial by examining the safety and efficacy of a daily administration of 2mg of tesamorelin for 26 weeks.
Christian Marsolais, vice president, clinical research of Theratechnologies, said: “Data from this confirmatory Phase III trial are very important as they will allow us to move forward with the preparation of the documentation required to submit a new drug application for tesamorelin to the FDA by the end of 2008.”