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news.Theratechnologies has received a special protocol assessment from the FDA for the design of its second pivotal phase III trial evaluating TH9507 for the treatment of HIV-associated lipodystrophy.
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Theratechnologies launched its TH9507 pivotal phase III program in March 2005. The first 412-patient clinical trial began in June 2005 and patient enrolment at 43 clinical sites across North America was completed on schedule in March 2006, with results expected around the end of this year.
The second trial will test TH9507 in approximately 400 additional patients in North America and Europe. It is patterned after the first trial and is intended to confirm its results. The company plans to initiate the new phase III trial in the first quarter of 2007.
The special protocol assessment (SPA) provides Theratechnologies with binding written agreement that the proposed design and analysis of the study are adequate to support a marketing application provided the study is performed in accordance with the SPA and the results are successful.