THERATECHNOLOGIES LAUNCHES TRIAL OF LIPODYSTROPHY DRUG

Theratechnologies has enrolled the first patient in its second Phase III clinical trial testing TH9507 in HIV-associated lipodystrophy. The objective of the new study is to confirm, for regulatory purposes, the beneficial effects seen in the first Phase III study, the top-line results of which were made public in December 2006.

"We are pleased to have initiated this second trial so soon after announcing positive results from the first Phase III trial," Yves Rosconi, the company's president and CEO, said. "Our first trial comfortably met its primary endpoint, and we are aiming to repeat that result in this confirmatory trial. For the new trial, we expect to complete patient enrollment in the third quarter of this year, which will put us on course to announce results in the first quarter of 2008."

The new trial is a multicenter, double-blind, randomized, placebo-controlled study being conducted in more than 60 centers in the U.S., Canada and Europe. The study is 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, which is a risk factor for cardiovascular disease and Type 2 diabetes.