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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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