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Theratechnologies: TH9507 Phase 3 Clinical Update

trolled 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.

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