Theratechnologies inc.
TSX : TH

Theratechnologies inc.

May 02, 2007 09:42 ET

Theratechnologies: Last Patient Treated in First Pivotal TH9507 Study

MONTREAL, QUEBEC--(CCNMatthews - May 2, 2007) - Theratechnologies (TSX:TH) announced today that the last patient has completed 52 weeks of treatment in its first Phase 3 clinical study testing TH9507 in HIV-associated lipodystrophy. The Company expects to be in a position to present top-line, 52-week results at an appropriate venue later this year. This TH9507 Phase 3 trial is a multi-center, double-blind, randomized, placebo-controlled study conducted in 41 centers in the United States and Canada. The study is examining the safety and efficacy of a daily administration of 2 milligrams of TH9507 for a period of 26 weeks and long-term safety over a period of 52 weeks. A second, confirmatory Phase 3 study got underway in January 2007.

"We are pleased to have completed the final phase of our first Phase 3 study on schedule," said Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "The long-term safety data that we will obtain from this extension phase are important to the ultimate positioning of TH9507 as a treatment for excess visceral fat accumulation in HIV patients. All of the data we have presented thus far indicate that TH9507 may offer an attractive combination of efficacy and safety with potential advantages over other approaches being developed for HIV-associated lipodystrophy," Mr. Rosconi stated.

The Company also announced that data from the first 26 weeks of this study will be presented at ENDO, the 89th annual meeting of the Endocrine Society, to be held in Toronto from June 2 to June 5, 2007. The presentation will be made by Dr. Steve Grinspoon, Associate Professor of Medicine, Harvard Medical School and lead investigator for the TH9507 trial in the United States. ENDO is the largest meeting of its type in the world. Approximately 7,000 researchers, scientists, and clinicians from across the globe are expected to assemble for this premier meeting of hormone research and endocrinology.

Theratechnologies previously announced positive results for the initial phase of the study on December 19, 2006. The primary endpoint and important secondary endpoints were achieved. The study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. After 26 weeks, patients on TH9507 achieved a 15% reduction in VAT versus baseline and a 20% difference versus placebo. In general, TH9507 was shown to be well tolerated by patients.

HIV-associated Lipodystrophy

HIV-associated lipodystrophy is characterized by a change in the distribution of adipose tissue (fat containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include visceral fat accumulation and/or loss of subcutaneous fat, generally in the limbs and in the face. There is no treatment available for the accumulation of visceral fat found in patients with HIV-associated lipodystrophy. It is estimated that approximately 250,000 HIV-infected patients in North America and Europe suffer an excessive accumulation of visceral fat.

About Theratechnologies

Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers or acquires innovative drug candidates in order to develop them and bring them to market. The Company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is TH9507, now in Phase 3 clinical trials for a serious metabolic disorder known as HIV-associated lipodystrophy. The Company also has other projects at earlier stages of development.

Forward-looking statements

This press release contains forward-looking statements regarding the timing of the data analysis of the first pivotal Phase 3 trial using TH9507. By their very nature, these statements involve uncertainties and inherent risks, both general and specific, which give rise to the possibility that the predictions will not materialize. We therefore caution investors against placing undue reliance on these statements. We refer you to pages 16 - 18 of the 2006 Annual Report, which contain a more exhaustive analysis of the risks and uncertainties connected to the business of the Company. We have no obligation to update forward-looking statements and we do not undertake to do so.

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