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Theratechnologies Phase III HIV trial in ‘07

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Theratechnologies plans to start enrolling patients in a new Phase III trial evaluating its growth hormone-releasing factor analogue TH9507 for treatment of HIV-associated lipodystrophy in the first quarter of 2007. The company launched its Phase III program in March 2005 and began enrolling patients at 43 clinical sites in North America in June. Under an August special protocol assessment agreement, the firm is permitted to conduct a second trial to test an additional 400 patients in North America and Europe to confirm results. The primary endpoint is an 8% reduction in visceral adipose tissue...
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