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ThGRF in HIV-related lipodystrophy: Phase II clinical trial in Canada and
the US
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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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