Theratechnologies Announces Publication in AIDS
MONTREAL, Sept. 2, 2008 – 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.
Contact:
Andrea Gilpin
Vice President, IR & Communications
Theratechnologies Inc.
Phone: 514 336-7800, ext. 205
communications@theratech.com
