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Phase 3 Study Shows Growth Hormone Releasing Factor Tesamorelin Reduces Excess Visceral Fat in HIV patients

Theratechnologies announced on June 18, 2008, results from its confirmatory Phase 3 clinical trial evaluating tesamorelin in HIV patients with excess visceral fat. Tesamorelin is a growth hormone-releasing factor analog that stimulates secretion of growth hormone. It is currently being studied in HIV/AIDS patients for the treatment of excess visceral adipose tissue (VAT). Many HIV patients taking antiretroviral therapy have excess VAT, or lipohypertrophy, which may increase the risk of cardiovascular disease and often results in unwanted body shape changes.

Visceral Fat.
Buffalo Hump

The 26-week study met its primary and secondary endpoints, confirming results from an initial Phase 3 study, according to the company. Results showed that patients treated with tesamorelin for 26 weeks achieved an average 11% decrease in VAT from baseline without significant changes in subcutaneous adipose tissue.

The study also met important secondary endpoints related to body image, triglyceride levels, total cholesterol to HDL ratio, and insulin growth factor (IGF)-1 levels, all of which confirm the positive results obtained in the earlier Phase 3 study, according to the company's press release.

Theratechnologies presented tesamorelin data from its first Phase 3 trial this week at ENDO 2008, the Endocrine Society's Annual Meeting (June 15-18). That trial showed that a clinically significant decrease in triglycerides was maintained at week 52.

Following is an edited version of the recent press release from Theratechnologies:

Theratechnologies Reports Positive 26-week Results for its Second Tesamorelin Phase 3 Trial


Montreal, Canada -- June 18, 2008 -- Theratechnologies (TSX:TH) today announced positive 26-week results for its confirmatory Phase 3 clinical trial, evaluating the efficacy of the company's lead compound, tesamorelin, in patients with HIV-associated lipodystrophy. As described in the protocol and agreed to by the U.S. Food and Drug Administration (FDA) through the Special Protocol Assessment (SPA) process, the study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. The study met its primary endpoint as well as important secondary endpoints, confirming the positive results obtained in the Company's initial Phase 3 study.

"In this second Phase 3 trial, tesamorelin is again proving to be efficacious at reducing VAT, without reducing subcutaneous adipose tissue (SAT), while being well tolerated in patients," commented Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "These confirmatory data are critical to the New Drug Application (NDA) submission that is in preparation to obtain market approval for tesamorelin," concluded Mr. Rosconi.

"Once again, we have met key clinical endpoints, this time treating European as well as North American HIV positive patients," commented Dr. Christian Marsolais, Vice President, Clinical Research of Theratechnologies. "These data add further strength to tesamorelin's product profile for a disease with no approved treatment available. We thank all our employees, collaborators, principal investigators and, particularly, the patients for their participation in this trial," added Dr. Marsolais.

Efficacy Results

The primary endpoint for the study was VAT reduction while the four secondary endpoints were positive changes in body image (belly appearance distress), triglyceride levels, the total cholesterol to HDL ratio and IGF-1 levels.

Patients treated with tesamorelin for 26 weeks achieved an average of 11% decrease in VAT versus baseline (p<0.001) and 10% versus placebo (p < 0.001). In absolute terms, the average VAT reduction was -20.6 square centimeters (p<0.001 versus placebo). Body fat was preferentially lost in the visceral cavity, with no significant changes in SAT.

This study also demonstrated that treated patients significantly improved their belly appearance distress compared to the placebo group (p= 0.02). This is considered to be an important endpoint because of its implications for patient adherence to HIV regimens.

With respect to lipid profiles, a trend for improvement in triglyceride levels was recorded for the treated group versus placebo (p=0.08) and was significantly different versus baseline (p=0.006). There was no significant impact on the total cholesterol to HDL cholesterol ratio.

IGF-1 mean levels were within physiological range and increased by 73% compared to placebo (p<0.001).

Safety

There were no clinically significant differences between the tesamorelin-treated group and placebo in glycemic control. Adverse events with an incidence of more than 10% were: injection site redness (erythema: 14.1% versus 4.8% for placebo); injection site itchiness (pruritis: 10.4% versus 1.6% for placebo); and joint pain (arthralgia: 12.2% versus 11.1% for placebo). The dropout rate for the patients treated with tesamorelin was 25% compared to 27% for the placebo group.

ENDO 2008

Theratechnologies also presented data yesterday from its first 52-week Phase 3 study testing tesamorelin in HIV-associated lipodystrophy at ENDO, the 90th annual meeting of the Endocrine Society. The presentation reviewed previously disclosed glucose tolerance and lipid data and was made by Donald Kotler, MD, an investigator for the tesamorelin trial in the United States. Dr. Kotler is also Chief, Division of Gastroenterology and Liver Disease, St. Luke's-Roosevelt Hospital Center and Columbia University College of Physicians and Surgeons, in New York.

For more information, visit www.theratech.com.

6/20/08

Source
Theratechnologies, Inc. Theratechnologies Reports Positive 26-week Results for its Second Tesamorelin Phase 3 Trial. Press Release. June 18, 2008.

 

 

 

 

 

 

 

 

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