AEGiS-PRn: Theratechnologies completes enrollment for Phase II trial in HIV-related lipodystrophy PRNewswireImportant note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
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Theratechnologies completes enrollment for Phase II trial in HIV-related lipodystrophy

PRNewswire - December 11, 2003


MONTREAL, Dec. 11 /PRNewswire-FirstCall/ - Theratechnologies announced today that it has completed enrolment for its Phase II clinical study in HIV-related lipodystrophy using ThGRF. HIV-related lipodystrophy is a metabolic syndrome that affects a large number of patients who are otherwise well controlled for HIV, and is characterized by abdominal adiposity (fat accumulation), increased cholesterol levels and glucose intolerance. The trial, which aims to assess the safety and efficacy of ThGRF in reducing abdominal adiposity, began in May 2003 and the results are expected at the end of the first quarter of 2004.

HIV-related lipodystrophy patients are more prone to type II diabetes, and recent data have demonstrated that this metabolic syndrome is associated with increased cardiovascular complications. It also raises other medical concerns, including potential non-compliance to HIV medication, in addition to having a negative impact on quality of life. The Company estimates that there are approximately 250,000 patients worldwide who are experiencing signs of HIV lipodystrophy. Currently, there is no approved drug or therapy for this medical condition.

About the study

This double-blind, placebo-controlled study is being conducted in seven centers in Canada and the United States. The goal was to enroll up to 60 patients who are to receive a daily subcutaneous injection of 1 mg, 2 mg or placebo, over a period of 12 weeks in order to measure reduction of abdominal adiposity. Various other parameters are being monitored, including cholesterol, insulin sensitivity, body composition and markers of bone metabolism.

About ThGRF

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.

The clinical studies conducted to date, involving over 500 healthy subjects and patients, have established a safety profile for ThGRF that differentiates it from growth-hormone-based products. In addition, its emerging pharmacological profile identifies two distinct mechanisms of action and two therapeutic fields, each with attractive market potential.

- Because of its positive effect on the secretion of an anabolic factor known as IGF-1, ThGRF may have a therapeutic effect on catabolic states characterized by a reduction in the ability to synthesize proteins, as well as muscle wasting and cachexia, which often lead to loss of autonomy and death. The Company has undertaken two efficacy studies in this field, wasting associated with chronic obstructive pulmonary disease (COPD) and hip fracture recovery.

Preliminary data from the COPD wasting study demonstrated that ThGRF induced a clear anabolic effect in patients in whom muscle wasting is known to be a predictor of mortality. Other findings included a reduction in fat mass, a very good safety profile and a series of converging positive data on functional measures. The final data are presently being assembled and the Company is concurrently preparing the regulatory strategy for a late-stage clinical trial in COPD wasting. Hip fracture patients suffer from intense and acute metabolic stress and in this case the drug did not improve functional recovery.

- The second therapeutic field is related to ThGRF's cholesterol-lowering effect and the direct lipolytic effect of growth hormone. These effects give ThGRF therapeutic potential in certain metabolic diseases such as HIV-related lipodystrophy referred to in this press release. Positive results in this indication could enlarge the field of investigation for ThGRF to include the metabolic syndrome (Syndrome X).

About Theratechnologies

Theratechnologies is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body's synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies. Its subsidiary, Celmed BioSciences, develops cell-based therapies for the treatment of hematological, immune and neurodegenerative disorders.

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 indications 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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