Healthcare Industry News: Theratechnologies
News Release - October 25, 2006
Theratechnologies: Last Patient Treated in Pivotal TH9507 TrialMONTREAL, QUEBEC--(Healthcare Sales & Marketing Network)--Oct 25, 2006 -- Theratechnologies (TSX:TH.TO ) announced today that it has completed the efficacy phase (26 weeks of treatment) of its first Phase 3 clinical trial testing TH9507 in HIV-associated lipodystrophy. The Company is now proceeding to assemble and refine the data with a view to locking the database in December. Once these steps have been completed, the results will be analyzed and made public.
This Phase 3 trial is a multi-center, double-blind, randomized, placebo-controlled study conducted in 43 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. The primary endpoint is a reduction of visceral adipose tissue, or VAT, which is a risk factor for cardiovascular disease and type 2 diabetes.
"We are pleased to have completed the efficacy phase of our Phase 3 trial on schedule," said Yves Rosconi, President and Chief Executive Officer. "Our success in consistently meeting the timelines for this study is an important achievement, due largely to an outstanding effort by our employees as well as support from our top-notch outside resources. It's also worth noting," Mr. Rosconi added, "that the rapid progress of our trial indicates strong interest and commitment by participants in the study, in particular, the medical community and patients."
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.
Theratechnologies (TSX:TH.TO ) 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 promising projects at earlier stages of development.
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 predictions will not materialize. We therefore caution investors against placing undue reliance on these statements. We refer you to pages 16 and 17 of the 2005 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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