Healthcare Industry News: Theratechnologies
News Release - August 23, 2006
Theratechnologies Receives Special Protocol Assessment From FDA for Second Pivotal Phase 3 Trial With TH9507MONTREAL, QUEBEC--(Healthcare Sales & Marketing Network)--Aug 23, 2006 -- Theratechnologies (TSX:TH.TO ) today announced a Special Protocol Assessment (SPA) from the U. S. Food and Drug Administration for the design of its second pivotal Phase 3 trial evaluating TH9507 for the treatment of HIV-associated lipodystrophy. Company plans call for the new Phase 3 trial to start in the first quarter of 2007.
Theratechnologies launched its TH9507 pivotal Phase 3 program in March 2005. The first 412-patient clinical trial began in June 2005 and patient enrolment at 43 clinical sites across North America was completed on schedule in March 2006 with results expected around the end of this year. The second trial will test TH9507 in approximately 400 additional patients in North America and Europe. It is patterned after the first trial and is intended to confirm its results. The FDA has now formally evaluated the protocol for this second trial through the SPA process. The SPA provides the Company with binding written agreement that the proposed design and analysis of the study are adequate to support a marketing application provided the study is performed in accordance with the SPA and the results are successful.
"We view this SPA as insurance against some of the regulatory risks associated with our Phase 3 program," said Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "The drug development landscape in HIV-associated lipodystrophy has evolved considerably since March 2005 when we first met the FDA to discuss our plans and we felt it would be prudent to validate our assumptions before embarking on the final leg of the program. The SPA tells us that our development strategy is on target and continues to meet regulatory requirements in the U.S. Of particular note, we have reconfirmed the primary end point as an 8% reduction in visceral adipose tissue (VAT) and obtained the FDA's approval of the statistical analysis approach that we will use to measure the change in VAT," Mr. Rosconi stated.
Theratechnologies (TSX:TH.TO ) is a Canadian biopharmaceutical company that discovers or acquires novel therapeutic products for development and commercialization. These products target unmet medical needs in commercially attractive specialty markets. The most advanced program is in Phase 3 clinical development in HIV-associated lipodystrophy. The Company also has other promising projects at various stages of development.
This press release contains forward-looking statements regarding the second pivotal Phase 3 trial with TH9507. The launch and conduct of this trial are dependant, among others, on the timing and results of the first Phase 3 trial. By their very nature, these statements involve uncertainties and inherent risks, both general and specific, which give rise to the possibility that these 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.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.