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Phase 3 Trials of ThGRF (TH9507) in HIV-Associated Lipodystrophy To Be Initiated
In response to a series of questions, the FDA indicated that it agrees with the Company's Phase III study design, the dose to be tested, and the use of visceral adipose tissue (VAT) as the primary endpoint. Secondary endpoints include lipid measures and body self-image. The FDA has also indicated that it accepts the Company's proposed inclusion of glucose-intolerant and diabetic patients in the study, with careful monitoring of glycemic control.
Based on the encouraging response from the FDA, the Company plans to stage two Phase III trials testing ThGRF in HIV-associated lipodystrophy patients. The first trial is expected to begin by mid-year.
"This a great day for Theratechnologies," said Yves Rosconi, President and Chief Executive Officer of the Company. "The FDA response to our submission is positive and strikingly clear. We now understand very well what the regulatory requirements are and our Phase II results give us confidence that we can meet those requirements. From a shareholder value perspective, we can look forward to completing the development of ThGRF in this first indication and begin preparations for a product launch in a market that could reach several hundred million dollars. In short, this is a major achievement and a wonderful tribute to our team of employees," Mr. Rosconi concluded.
About HIV-associated Lipodystrophy
HIV-associated lipodystrophy is a metabolic syndrome that afflicts a large percentage of HIV patients undergoing antiretroviral therapy. It is characterized by changes in distribution of adipose tissue (fat-containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include visceral fat accumulation and/or the loss of subcutaneous fat, generally in the limbs and facial area.
There is currently no approved treatment for HIV-associated lipodystrophy, and although some new HIV treatments have shown signs of improving metabolic components of the disease, the accumulation of visceral fat, and the related complications, remains an important unmet medical need. It is estimated that, among the 1.4 million HIV-positive patients in North America and Europe, as many as 200,000 suffer from HIV-associated lipodystrophy with excess visceral fat.
ThGRF 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 related to aging and obesity, as these conditions are characterized by a significant reduction in growth hormone secretion.