Theratechnologies Announces Publication in AIDS
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MONTREAL, CANADA, Sep 02 (MARKET WIRE) --
Theratechnologies (TSX: TH) today announced that the 52-week results from
its first Phase 3 clinical trial, using tesamorelin, are published in the
September 2, 2008 Journal of the International AIDS Society
(www.aidsonline.com). The study entitled, "Long-term safety and effects
of tesamorelin, a growth hormone-releasing factor analogue, in HIV
patients with abdominal fat accumulation" outlines, in detail, the
52-week data of the first Phase 3 trial. Top-line results were initially
disclosed in October 2007.
"The long-term data discussed in this publication are congruent with
previous efficacy and safety data and highlight the ability of
tesamorelin to be used in the long-term. Moreover, no new or unexpected
side effects occurred with the long-term exposure which is building an
attractive product profile for tesamorelin," commented Mr. Yves Rosconi,
President and Chief Executive Officer of Theratechnologies. "I would like
to take this opportunity to thank all the people involved in the study,"
added Mr. Rosconi.
"Excess visceral fat is associated with insulin resistance, altered lipid
levels, and contributes to increased cardiovascular risk. The ability of
tesamorelin to specifically reduce excess visceral adipose tissue (VAT)
without impacting insulin resistance, long term, is an important clinical
attribute for tesamorelin," commented Dr. Steven Grinspoon, Professor of
Medicine, Harvard Medical School, Director of the Massachusetts General
Hospital Program in Nutritional Metabolism, Lead Investigator for the
tesamorelin trial in the United States and corresponding author for the
AIDS publication. "The maintenance of VAT reduction over 52 weeks
compared to baseline is clinically significant, though this effect is
lost once treatment with tesamorelin is stopped," noted Dr. Grinspoon.
"The publication of our long-term data in AIDS demonstrates the impact
that excess visceral fat can have on HIV-infected patients with
lipodystrophy and the data discussed therein shows that tesamorelin can
safely be used over the long term," commented Dr. Julian Falutz,
Director, HIV Metabolic Clinic, McGill University Health Centre,
Assistant Professor, McGill University Medical School, and Lead
Investigator for Canada. "These positive results bring hope to those
patients who have a reduced quality of life that is brought about by
having excess abdominal fat in the setting of HIV/HAART associated
lipodystrophy," said Dr. Falutz.
HIV-Associated Lipodystrophy
Caused by several factors including the antiviral drug regimen and the
virus itself, HIV-associated lipodystrophy is characterized by body
composition changes, dyslipidemia and glucose intolerance. The changes in
body composition include excess visceral fat accumulation and loss of
subcutaneous fat in the limbs and in the face. Excess VAT and its
concomitant metabolic profile have recently been shown to be a risk
factor for cardiovascular diseases in HIV patients. There is currently no
approved treatment available for HIV-associated lipodystrophy, a serious
condition that can stigmatize patients and discourage HIV treatment
adherence.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that
discovers innovative drug candidates in order to develop them and bring
them to market. The Company targets unmet medical needs in financially
attractive specialty markets. Its most advanced program is tesamorelin,
now in a confirmatory Phase 3 clinical trial for a serious metabolic
disorder known as HIV-associated lipodystrophy. The Company also has
other projects at earlier stages of development.
Forward-looking statements
This press release contains certain statements that are considered
"forward-looking information" within the meaning of applicable securities
legislation. This forward-looking information includes, but is not
limited to information regarding the efficacy of tesamorelin on the
health of patients with HIV-associated lipodystrophy. Words such as
"will", "may", "could", "should", "outlook", "believe", "plan",
"envisage", "anticipate", "expect" and "estimate", or the negatives of
these terms or variations of them and the use of the conditional tense as
well as similar expressions denote forward-looking information.
Forward-looking information is based upon a number of assumptions and is
subject to a number of risks and uncertainties, many of which are beyond
the Company's control that could cause actual results to differ
materially from those that are disclosed in or implied by such
forward-looking information. These risks and uncertainties include, but
are not limited to, the risk that patients with HIV-associated
lipodystrophy using tesamorelin experience results that may differ from
those indicated herein. The Company refers potential investors to the
"Risks and Uncertainties" section of its annual information form (the
"AIF") dated January 29, 2008. The AIF is available at www.sedar.com
under the Company's public filings.
Although the forward-looking information contained in this press release
is based upon what the Company believes are reasonable assumptions,
investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking
information. Certain assumptions made in preparing the forward-looking
information include the assumption that patients with HIV-associated
lipodystrophy will react positively to the administration of tesamorelin
in the long term.
Consequently, all of the forward-looking information contained in this
press release is qualified by the foregoing cautionary statements, and
there can be no guarantee that the results or developments anticipated by
the Company will be realized or, even if substantially realized, that
they will have the expected consequences or effects on the Company, its
business, financial condition or results of operation. The Company does
not undertake to update or amend such forward-looking information whether
as a result of new information, future events or otherwise, except as may
be required by applicable law.
Contacts:
Theratechnologies Inc.
Andrea Gilpin
Vice President, IR & Communications
514-336-7800, ext. 205
communications@theratech.com
Copyright 2008, Market Wire, All rights reserved.
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