Theratechnologies has started the Phase III clinical trial testing of Theratechnologies' TH9507 (ThGRF) compound in HIV associated lipodystrophy, a condition that affects many patients undergoing HIV antiretroviral therapy in Atlanta, Georgia.
Yves Rosconi, president and CEO of Theratechnologies says, "Including the Atlanta site, we now have 6 of the projected 35 sites actively recruiting patients and we are working hard towards opening the remaining 29 sites and recruiting the 400 patients we need to complete the study. Our goal is to announce results in the second half of 2006."
HIV-associated lipodystrophy is characterized by changes in distribution of adipose tissue (fat-containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include visceral adipose tissue (VAT) accumulation and/or the loss of subcutaneous fat, generally in the limbs and facial area. The multi-centre, randomized, double-blind, placebo-controlled Phase III clinical trial is investigating the safety and efficacy of TH9507 in reducing excess VAT in approximately 400 patients by administering 2 mg daily for a period of 26 weeks. There will also be an extension phase of the study lasting an additional 26 weeks to assess long-term safety and the effects of discontinuing treatment.
"Our market studies indicate that among the 1.1 million HIV-positive patients in North America and Europe, nearly 200,000 suffer from HIV-associated lipodystrophy with excess VAT accumulation", Rosconi said.
TH9507 is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces the production and secretion of growth hormone in a specific, physiological, controlled and pulsatile fashion. This property makes it a strong candidate as a potential treatment for many diseases characterized by a reduction in growth hormone secretion.
Theratechnologies is a Canadian biopharmaceutical company engaged in the discovery and development of therapeutic peptides in the field of endocrinology and metabolism.