Theratechnologies inc.
TSX : TH

Theratechnologies inc.

June 04, 2007 14:18 ET

Theratechnologies: TH9507 Phase 3 Clinical Update

- Data from first Phase 3 trial presented at ENDO 2007 - Regulatory approvals for second Phase 3 trial open the door for patient recruitment in Europe

MONTREAL, QUEBEC--(Marketwire - June 4, 2007) - Theratechnologies (TSX:TH) reported today that 26-week data from its first Phase 3 study testing TH9507 in HIV-associated lipodystrophy were presented today in Toronto at ENDO, the 89th annual meeting of the Endocrine Society. The presentation was made by Dr. Steve Grinspoon, Associate Professor of Medicine, Harvard Medical School and lead investigator for the TH9507 trial in the United States.

Positive 26-week results were recently presented at the 14th Conference on Retroviruses and Opportunistic Infections (CROI). 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.

Dr. Grinspoon's presentation today particularly highlighted beneficial effects of TH9507 on key metabolic parameters known to be risk factors for cardiovascular diseases, suggesting that strategies using a growth hormone releasing factor will reduce abdominal obesity and may lower cardiovascular risk in HIV patients.

Since the initiation of the trial in January, Theratechnologies has obtained regulatory approval in five European countries for its second Phase 3 clinical study testing TH9507 in HIV-associated lipodystrophy. Patients are being enrolled for the study in Belgium, France, Italy, Spain and the United Kingdom. North American recruitment previously began in the United States in January and Canadian recruitment began in May.

The second Phase 3 trial is a 400-patient, multi-center, double-blind, randomized, placebo-controlled study conducted in 66 centers in North America and Europe. It is designed to confirm the results of the earlier Phase 3 trial by examining the safety and efficacy of a daily administration of 2 mg of TH9507 for a period of 26 weeks. The primary endpoint is a reduction of visceral adipose tissue, or VAT. In August 2006, the protocol for this second Phase 3 trial was approved by the Food and Drug Administration (FDA) in the United States through the Special Protocol Assessment (SPA) process.

"We have now secured the necessary regulatory approvals for the European arm of our trial," said Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "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. This is potentially very good news for patients and this marks the first time that our drug is being made available to European HIV-associated lipodystrophy patients," Mr. Rosconi stated.

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 ENDO

ENDO is the annual meeting of the Endocrine Society, and is the largest meeting of its type in the world. Approximately 7,000 researchers, scientists, and clinicians from across the globe have assembled in Toronto for this premier meeting of hormone research and endocrinology.

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 conduct of the Company's clinical program. 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.

Contact Information

  • Theratechnologies Inc.
    Andrea Gilpin
    Executive Director, IR & Communications
    514-336-4804 x 205
    agilpin@theratech.com