Theratechnologies inc.
TSX : TH

Theratechnologies inc.

July 18, 2007 03:00 ET

Theratechnologies/TH9507 Phase 3 Clinical Update at International HIV Meeting

- TH9507 Improved the Perception of Belly Image

MONTREAL, QUEBEC--(Marketwire - July 18, 2007) - Theratechnologies (TSX:TH) reported today that new positive data related to body image from the first 26 weeks of its first Phase 3 study testing TH9507 in HIV-associated lipodystrophy have been presented in Sydney, Australia. The poster presentation (Poster Number:22, Reference Number:10C1002), at the 9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, was authored by Dr. Ralph Turner, M.A., Ph.D., M.P.H., Vice President and Senior Research Investigator of Phase V Technologies, and collaborators. Phase V Technologies is an independent company responsible for evaluating the quality of life parameter in Theratechnologies' pivotal Phase 3 clinical trial. The body image data is the fourth secondary efficacy endpoint to be announced of the first Phase 3 trial (26 week data).

HIV-associated lipodystrophy is characterized by changes in the distribution of adipose tissue (fat containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include visceral adipose tissue (VAT) accumulation and/or loss of subcutaneous fat. These changes can result in impaired body image and are considered to be potential barriers to treatment adherence.

Dr. Turner's poster presentation in Sydney focused on body image. The study showed that patients treated with 2 mg daily of TH9507 significantly improved their perception of belly image compared to the placebo group. This improved perception of belly image may have important implications for HIV treatment outcomes.

"Strict adherence to anti retroviral regimens is critical in the management of HIV and gives rise to considerable concern about the stigmatizing body changes associated with these therapies," said Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "Since stress related to body image may actually lead patients to discontinue their HIV treatments, reducing stress could be very beneficial," he explained. "The body image data provide further evidence that TH9507 may offer an attractive treatment option for HIV-associated lipodystrophy, with potential advantages over other approaches being developed," Mr. Rosconi concluded.

Positive 26-week data on reduction of VAT, the primary endpoint of the study, and certain secondary endpoints were made public earlier this year at the 14th Conference on Retroviruses and Opportunistic Infections (CROI) in Los Angeles, California. The study was powered to detect an 8% reduction in VAT versus placebo. After 26 weeks, patients on TH9507 achieved a 15% reduction in VAT versus baseline and a 20% difference versus placebo. The three additional secondary endpoints were: cholesterol/HDL-cholesterol index; triglyceride levels; and IGF-1 levels, all of which were met at 26 weeks in this clinical trial.

In a second presentation on July 19th at this conference, Dr. Steve Grinspoon, Associate Professor of Medicine, Harvard Medical School and lead investigator for the TH9507 trial in the United States, will discuss data on TH9507's effect on body composition and metabolic parameters in HIV-infected patients with lipodystrophy.

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.

The International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV

The International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV has established itself as the ideal setting for the presentation of new scientific data in the field of metabolic complications, lipodystrophy, drug toxicities and related topics in HIV. The 2007 congress will continue to act as a lively discussion forum, allowing treating physicians and researchers to exchange information while increasing the understanding of underlying mechanisms and approaches to the management of lipodystrophy and the many other adverse events associated with antiretroviral therapy.

Phase V Technologies

Phase V's clinical and outcomes research services include strategic planning, design, conduct, evaluation, and analysis of clinical trials. As part of new drug and device development the Phase V® Outcomes Research System focuses on evaluating the effectiveness and acceptance of new therapies from the patient and health economic perspective. Employing the most current methods for evaluating clinical effectiveness, health status, quality of life and patient satisfaction, the company's research mission is to produce patient data of the highest scientific quality and integrity.

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 reflecting the Company's current expectations regarding the TH9507 Phase 3 clinical program including, among others, the nature of the results and their timing, and the future development of the Company. 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 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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