MONTREAL, QUEBEC--(Marketwire - February 09, 2009) - Theratechnologies (TSX: TH) today announced results from sub-groups of patients with Atherogenic Lipid Profile (ALP), drawn from the combined analysis of its two Phase 3 clinical trials testing tesamorelin, its investigational compound, in HIV-associated lipodystrophy. ALP(+) patients have elevated triglyceride levels and low levels of HDL cholesterol. The goal of the sub-groups analysis was to determine whether there was a different response in HIV-associated lipodystrophy patients who are ALP(+), compared with those with a normal lipid profile. The results were presented on February 9, 2009 at the 16th Conference on Retroviruses and Opportunistic Infections (CROI) in Montreal, Canada (Poster Number 713).
This sub-groups analysis is drawn from the Company’s two pivotal trials with a total of 816 patients treated with 2mg daily of tesamorelin for 26 weeks. At baseline, ALP(+) patients were associated with a greater progression of metabolic variables. In both treated and placebo groups, they were found to have a greater excess of abdominal fat (218+/-94 and 231+/-101 cm2, ALP+ vs. 176+/-79 and 160+/-62 cm2, ALP-) and higher insulin levels (307+/-438 and 174+/-102 pmol/L, ALP+ vs. 99+/-69 and 119+/-117 pmol/L, ALP-) than those patients that had a normal lipid profile. Among those patients treated with tesamorelin, triglycerides decreased significantly (p equals 0.01) in the ALP(+) group (-1.00+/-0.26 mmol/L) compared to those in the normal lipid level group (-0.10+/-0.17 mmol/L). Tesamorelin reduced excess abdominal fat in both lipid profile groups
(-12.5+/-7.0 and -19.0+/-4.6%, ALP+ and ALP- vs. 5.8+/-12.1 and 0.7+/-8.0%, ALP+ and ALP-) vs placebo (p less than0.01 vs placebo in either the ALP+ or ALP- group).
Both sub-groups were generated from Theratechnologies’ Phase 3 trials which included safety results that were previously disclosed. The poster presented at CROI today is now available on Theratechnologies’ website at www.theratech.com
About HIV-Associated Lipodystrophy
Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers 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 compound, tesamorelin, is an analogue of the growth hormone releasing factor. Theratechnologies recently concluded a confirmatory Phase 3 clinical trial evaluating in HIV-associated lipodystrophy, serious metabolic disorder associated with excess abdominal fat. The Company also has other projects at earlier stages of development.
Contacts:
Theratechnologies Inc.
Aline Vandermeer
Coordinator, IR & Communications
514-336-7800, ext. 229
514-336-7242 (FAX)
communications@theratech.com
www.theratech.com
