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. |