Major therapeutic breakthrough toward the treatment of HIV/HAART* - associated Lipodystrophy Syndrome



    MONTREAL, Dec. 6 /CNW Telbec/ - Researchers in Montreal and Boston have
identified a potential new treatment for the HIV/HAART(*)-associated
Lipodystrophy Syndrome. This syndrome is a common side-effect of
anti-retroviral medications to treat HIV infection. Dr. Julian Falutz,
Director of the HIV Metabolic Clinic at the McGill University Health Centre
(MUHC), and Dr. Steven Grinspoon, Director at the Massachusetts General
Hospital Program in Nutritional Metabolism are publishing the results of their
recent clinical trial in the December 6, 2007 issue of the New England Journal
of Medicine.
    The Lipodystrophy Syndrome consists of several metabolic disruptions that
lead to abnormal lipid and glucose levels, as well as a generalized decrease
in superficial fat tissues and an increase in deep abdominal fat. The observed
body shape changes may cause significant impairment of patients'
quality-of-life leading many patients to stop taking their anti-retroviral
medications. But the major health-threat related to the development of the
Lipodystrophy Syndrome is an increased long-term cardiovascular risk.
    Early in this decade, Dr. Falutz and Dr. Grinspoon began collaborating
with Theratechnologies Inc., a Montreal-based biotechnology company that had
developed a synthetic analogue of the naturally occurring growth
hormone-releasing factor (GRF-tesamorelin). Its action is to regulate growth
hormone levels that are important in controlling various metabolic processes.
The effectiveness of this drug in reducing increased deep abdominal fat, and
secondarily decreasing blood lipid levels, was initially confirmed in a small
phase II study published in 2005. The current published results are from a
large phase III Study conducted at 43 centers in the USA and Canada, which
followed 412 patients for 6 months.
    Its conclusions are decisive: "Patients treated with tesamorelin saw
their abdominal fat decrease by 15% on average, compared to a 5% average
increase for the placebo group", explained Dr. Falutz. "Also, the side-effects
are minimal".
    "This is a novel strategy to improve cardiovascular risk indices in
HIV-infected patients and could represent a therapeutic breakthrough for many
patients", stated Dr. Grinspoon.
    A second confirmatory trial is ongoing in order to comply with US FDA (US
Food and Drug Administration) regulations. "If this second clinical study is
as conclusive as the first, there is hope that patients will have tesamorelin
available as a treatment option for HIV-associated lipodystrophy within the
next couple of years.", said Dr. Falutz.

    The McGill University Health Centre (MUHC) is a comprehensive academic
health institution with an international reputation for excellence in clinical
programs, research and teaching. The MUHC is a merger of five teaching
hospitals affiliated with the Faculty of Medicine at McGill University-the
Montreal Children's, Montreal General, Royal Victoria, and Montreal
Neurological Hospitals, as well as the Montreal Chest Institute. Building on
the tradition of medical leadership of the founding hospitals, the goal of the
MUHC is to provide patient care based on the most advanced knowledge in the
health care field, and to contribute to the development of new knowledge.
www.muhc.ca

    The Research Institute of the McGill University Health Centre (RI MUHC)
is a world-renowned biomedical and health-care hospital research centre.
Located in Montreal, Quebec, the institute is the research arm of the MUHC, a
university health center affiliated with the Faculty of Medicine at McGill
University. The institute supports over 500 researchers, nearly 1000 graduate
and post-doctoral students and operates more than 300 laboratories devoted to
a broad spectrum of fundamental and clinical research. The Research Institute
operates at the forefront of knowledge, innovation and technology and is
inextricably linked to the clinical programs of the MUHC, ensuring that
patients benefit directly from the latest research-based knowledge. For
further details visit: www.muhc.ca/research.

    (*) HAART: Highly Active Anti-Retroviral Therapies




For further information:

For further information: Seeta Ramdas, Communication Coordinator, MUHC
Public Relations and Communications, (514) 934-1934, #34320,
seeta.ramdas@muhc.mcgill.ca; Isabelle Kling, Communications Coordinator
(research), MUHC Public Relations and Communications, (514) 934-1934, #36419,
isabelle.kling@muhc.mcgill.ca


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