Theratechnologies inc.

Theratechnologies inc.

March 23, 2006 08:21 ET

Theratechnologies Completes Patient Enrollment for TH9507 in First Phase 3 Trial :Results Expected by end of Year

MONTREAL, QUEBEC--(CCNMatthews - March 23, 2006) - Theratechnologies (TSX:TH) today announced it has completed patient enrollment for its first Phase 3 clinical trial using TH9507 for the treatment of HIV-associated lipodystrophy.

This Phase 3 study is a multi-center, double-blind, randomized, placebo-controlled study conducted in approximately 40 centers in 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 announce that we have achieved our objective and now have enough patients to complete the Phase 3 study. We have advised the clinical sites to stop enrollment and the patients currently in process should be randomized in the next few weeks. This puts us in a good position to announce the results by the end of the year and start the second Phase 3 trial in early 2007," said Yves Rosconi, President and Chief Executive Officer.

HIV-associated Lipodystrophy

There is currently no approved treatment for excess abdominal fat in HIV-associated lipodystrophy, a condition that affects a substantial percentage of HIV patients. It is characterized by major physical changes (notably abdominal fat accumulation and/or loss of peripheral subcutaneous fat) as well as lipid and carbohydrate disorders (high cholesterol and blood sugar), conditions that can foster cardiovascular disease and type 2 diabetes. Such abnormalities may also discourage compliance with HIV regimens.

Annual General Meeting

Theratechnologies' Annual Meeting of Shareholders will be held on Thursday, March 30, at 10:00 a.m., at Salon Mont-Royal II of the Centre Mont-Royal, 2200 Mansfield, Montreal.

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 where it can retain full or partial ownership of the drug and generate attractive returns for shareholders. 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.

Forward-looking statements

This press release contains forward-looking statements regarding the TH9507 Phase 3 clinical program including the nature of the results and their timing. 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 the forward-looking statement and we do not undertake to do so.

Contact Information

  • Theratechnologies Inc.
    Yves Rosconi
    President and Chief Executive Officer
    (514) 336-4804, ext. 203
    Theratechnologies Inc.
    Tobie Trudel
    Investor Relations
    (514) 336-4804, ext. 229