Theratechnologies inc.

Theratechnologies inc.

September 04, 2007 16:15 ET

Theratechnologies Completes Patient Recruitment for Tesamorelin in Confirmatory Phase 3 Trial

MONTREAL, QUEBEC--(Marketwire - Sept. 4, 2007) - Theratechnologies (TSX:TH) announced it has notified its principal investigators to end recruitment by September 11, 2007 for its confirmatory Phase 3 clinical trial using tesamorelin (TH9507) for the treatment of HIV-associated lipodystrophy. Patients recruited on or before this date will be screened and those eligible will be officially enrolled in the study within the next few weeks.

"The ability to complete our recruitment in seven months, especially over the summer season, attests to the medical interest in HIV-associated lipodystrophy," commented Dr. Christian Marsolais, Ph.D., Vice-President of Clinical Research for Theratechnologies. "The enthusiasm of both the patients and the principal investigators in this study was strong and we are grateful for their support," Dr. Marsolais noted.

The second confirmatory Phase 3 trial is a 400-patient, multi-center, double-blind, randomized, placebo-controlled study conducted in 48 centers in North America and Europe. It is designed to confirm the results of the first Phase 3 trial by examining the safety and efficacy of a daily administration of 2 mg of tesamorelin for 26 weeks. The primary endpoint is a reduction of visceral adipose tissue, or VAT. In August 2006, the protocol for this confirmatory Phase 3 trial was reviewed by the US FDA under the Special Protocol Assessment (SPA) process. Top-line data of the confirmatory Phase 3 trial is expected in the first half of 2008.

"It was our goal to complete patient enrollment in the third quarter of 2007 and indeed we have achieved this goal as planned," said Yves Rosconi, President and Chief Executive Officer of Theratechnologies. Mr. Rosconi further commented, "The inclusion of European sites in this trial has allowed us to develop relationships with key principle investigators thereby increasing Theratechnologies' profile in Europe."

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 and/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 tesamorelin, now in a second confirmatory Phase 3 clinical trial 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 conduct of the Company's clinical program and the disclosure of certain results associated therewith. 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 refer you to pages 15 to 19 of the 2006 Annual Information Form, which contain a more exhaustive analysis of the risks and uncertainties connected to the business of the Company. We have no obligation whatsoever to update forward-looking statements and we do not undertake to do so.

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