Healthcare Industry News: Theratechnologies
News Release - January 31, 2007
Theratechnologies Launches Confirmatory Phase 3 Trial Testing TH9507 in HIV-Associated LipodystrophyMONTREAL, QUEBEC--(Healthcare Sales & Marketing Network)--Jan 31, 2007 -- Theratechnologies (Toronto Future:TH.TO ) announced today that it has enrolled the first patient in its second Phase 3 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 Company's first Phase 3 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 3 trial in HIV-associated lipodystrophy," said Yves Rosconi, President and Chief Executive Officer. "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", Mr. Rosconi stated.
The new Phase 3 trial is a multi-center, double-blind, randomized, placebo-controlled study conducted in over 60 centers in the United States, Canada and Europe. The study, which is designed to confirm the results of the earlier Phase 3 trial, 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, or VAT, which is a risk factor for cardiovascular disease and type 2 diabetes.
In August 2006, the Company received a Special protocol Assessment (SPA) for this latest trial from the Food and Drug Administration (FDA) in the United States. A special protocol assessment documents the Agency's agreement that the design and planned analysis of a study adequately address objectives in support of a regulatory submission.
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.
Theratechnologies (Toronto Future:TH.TO ) 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 promising projects at earlier stages of development.
This press release contains forward-looking statements regarding the timing of the data analysis of the second pivotal Phase 3 trial using TH9507. 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 16 and 17 of the 2005 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.
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