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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 -- (MARKET WIRE) -- June 04, 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-con
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TAG: Theratechnologies Phase Clinical Update
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