Theratechnologies Presents Combined Phase 3 Clinical Results At European AIDS Conference

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Nov 2009 - 3:00 PST

email to a friend   printer friendly   view / write opinions   rate article

Theratechnologies (TSX:TH) announced that results from a pooled analysis from both its Phase 3 clinical trials evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy were presented as a poster (Poster number: #BPD2/1) at the 12th European AIDS Conference/EACS in Cologne, Germany. This Poster will also be presented as part of a "Best Poster" discussion on Friday. In addition, as part of its disease awareness program, Theratechnologies will also sponsor a symposium entitled "Lipohypertrophy: Beyond Body Image", which will be held tomorrow morning at the Conference.

The poster outlined pooled data from both Phase 3 clinical trials and demonstrated that treatment with 2 mg tesamorelin daily for 26 weeks resulted in:

- Significant visceral adipose tissue ("VAT") decrease in tesamorelin-treated patients after 26 weeks of treatment (-13.1 more or less 21.1% p less than 0.001 vs. placebo);

- No clinically significant changes in limb fat (0.2 more or less 13.2%, p=0.001 vs. placebo) and in abdominal subcutaneous adipose tissue ("SAT") (0.7 more or less 15.5%, p=0.08 vs. placebo);

- Significant decrease in triglycerides (-0.4 more or less 1.6 mmol/L, p less than 0.001 vs. placebo).

At Week 52, improvements in VAT and triglycerides observed at Week 26 were sustained in the group of patients who received tesamorelin over 52 weeks (-17.5 more or less 23.3% and -0.5 more or less 2.0 mmol/L, respectively, p less than 0.001 vs. baseline). Patients who were switched from tesamorelin to placebo treatment at Week 26, per the study design, regained VAT at Week 52 (0.3 more or less 26.3%, p=0.18 vs. baseline). No clinically important changes in glucose parameters were observed after treatment with tesamorelin at both Weeks 26 and 52.

The poster presented is now available on Theratechnologies' website at http://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.

Source
Theratechnologies