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ThGRF in HIV-related lipodystrophy: Phase II clinical trial in Canada and the US
  MONTREAL, May 22 /PRNewswire-FirstCall/ - Theratechnologies announces today that it has enrolled a first patient in a new Phase II clinical study for ThGRF, its growth hormone-releasing factor analogue, in HIV- related lipodystrophy, a syndrome which is characterized by a number of metabolic and physical abnormalities and affects a substantial percentage of patients on long-term HIV therapy. This trial, which is conducted in Canada and the United States, was designed on the basis of the favorable clinical profile of ThGRF observed in previous studies as well as on recent reports demonstrating clinical benefits with recombinant growth hormone in HIV lipodystrophic patients.
"Undertaking this trial fits with our ThGRF program strategy aimed at making ThGRF a clinical and commercial success. Our pioneering work with this product has led to the identification of catabolic states as a very important set of indications to be developed, with our COPD and hip fracture wasting trials well advanced. Considering recent data showing clinical benefits with recombinant growth hormone in HIV lipodystrophic patients, and ThGRF's good safety profile, we simply could not miss the opportunity to increase the probability of success of ThGRF, by targeting another set of medical conditions where the lipolytic effect of ThGRF could be beneficial", said Dr. Thierry Abribat, Vice President and Chief Scientific Officer of Theratechnologies.
"Documenting the clinical efficacy of ThGRF in a new therapeutic field with a strong rationale will make ThGRF even more attractive for potential partners, as this will increase the chance of success for this potential blockbuster." added Mr. Luc Tanguay, President and Chief Executive Officer of Theratechnologies. "This new study is perfectly in line with our approach to develop safe products for diseases and conditions for which there is a definite medical need, for the benefit of both patients and society."
About the study
Theratechnologies will be conducting this Phase II, multicenter, double- blind, placebo-controlled study in 5 to 7 centres in Canada and the United States to assess the safety and obtain preliminary efficacy data of ThGRF (TH9507) in patients with HIV-related lipodystrophy. This trial, which has already been through the regulatory submission and clearance process, will include as lead investigators Dr. Steven Grinspoon, Director of the Program in Nutritional Metabolism at the Massachusetts General Hospital and Assistant Professor at the Harvard Medical School in Boston, and Dr. Julian Falutz, Director of the HIV Metabolic Clinic at the Montreal General Hospital and Assistant Professor at McGill University in Montreal. Up to 60 patients will receive a daily subcutaneous injection of two doses (1 mg, 2 mg, or placebo) over a period of 12 weeks in order to measure reduction of visceral and truncal adiposity. Various other parameters will be monitored, including cholesterol, insulin sensitivity, body composition and markers of bone metabolism. Finally, immune parameters will be measured in an exploratory manner, as ThGRF has been shown in an earlier study to stimulate the cell- mediated immune system, the component of the immune system that is specifically depressed in AIDS.
About HIV-related lipodystrophy
HIV-related lipodystrophy is a syndrome affecting a large number of HIV patients otherwise well controlled for HIV, and characterized by a number of abnormalities including accumulation of abdominal fat, increased cholesterol levels and glucose intolerance, which increase the risk of atherosclerosis and cardiovascular complications. HIV-related lipodystrophy raises other potential medical concerns, including non-compliance to HIV medication, and has a negative impact on quality of life. Among the estimated one million HIV patients in the United States, 40% to 50% of those under HAART (Highly Active Antiretroviral Therapy) experience or will experience signs of HIV lipodystrophy. Currently, there is no drug or therapy on the market capable of reversing this medical condition.
Large-scale studies have recently demonstrated that recombinant growth hormone, through its lipolytic action, effectively reduced trunk fat and visceral adipose tissue in patients with HIV-related lipodystrophy, while increasing lean body mass and decreasing non-HDL cholesterol levels (atherogenic or bad cholesterol). However, safety concerns are associated with the use of growth hormone based products in patients with glucose intolerance, a condition frequently found in HIV lipodystrophic patients. On the basis of existing Phase II results confirming ThGRF's safety in elderly and diabetic patients, Theratechnologies anticipates that ThGRF may not cause the side- effects associated with these products, due to its ability to induce growth hormone secretion in a physiological and pulsatile fashion. In addition, cholesterol reductions reported in the safety trial in diabetic patients support the rationale for the use of ThGRF in this category of patients.
About ThGRF
Theratechnologies' ThGRF is a multiactive product which induces the production of growth hormone in a natural, controlled and pulsatile fashion. ThGRF could offer benefits to patients in a number of therapeutic indications, without causing the side-effects commonly associated with growth hormone. Theratechnologies is currently pursuing a broad Phase II clinical program in a variety of indications including muscle wasting observed in chronic obstructive pulmonary disease and hip fractures, as well as certain metabolic, immune and cognitive dysfonctions.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company boasts a rich and well-balanced peptide portfolio at various stages of development for the treatment of catabolic disorders (loss of the body's synthesis and regeneration capacity), as well as osteoporosis and type II diabetes. In addition, Theratechnologies expands its peptide portfolio through innovative technologies. Its subsidiary, Celmed BioSciences, is active in the field of cell therapy for the treatment of cancer and central nervous system disorders using adult stem cells. Theratechnologies' website is located at http://www.theratech.com. The Company is listed on the Toronto Stock Exchange under the symbol TH.
This press release contains forward-looking statements regarding the clinical development of ThGRF and its future commercialization in the indication described above. Such statements inherently involve numerous risks and uncertainties, including the availability of funds and resources, the success and timely completion of clinical trials and the granting of the necessary authorizations. Actual future results may differ materially from the anticipated results. Investors are cautioned against placing undue importance on forward-looking information contained herein and should consult the Company's 2002 Annual Report, which contains a more exhaustive analysis of risks and uncertainties connected to the businesses of the Company.
SOURCE Theratechnologies Inc.
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