THERATECHNOLOGIES TO BEGIN SECOND PHASE III TRIAL OF TH9507

Theratechnologies has received special protocol assessment (SPA) from the FDA for the design of its second Phase III trial evaluating TH9507 for the treatment of HIV-associated lipodystrophy. The company plans to start the trial in the first quarter of 2007.

Theratechnologies launched its TH9507 Phase III program in March 2005. The first 412-patient clinical trial began in June 2005, 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. Special protocol assessment provides the company with a binding written agreement that the proposed design is adequate to support a marketing application provided the study is performed in accordance with the agreement and is successful.

"We view this SPA as insurance against some of the regulatory risks associated with our Phase III program," Yves Rosconi, president and CEO of Theratechnologies, said. "The drug development landscape in HIV-associated lipodystrophy has evolved considerably since March 2005 when we first met the FDA to discuss our plans, and we felt it would be prudent to validate our assumptions before embarking on the final leg of the program."