Theratechnologies Presents Additional Results from Its Tesamorelin 52-week Phase 3 study at the Conference on Retroviruses and Opportunistic Infections
MONTREAL, Canada, February 6, 2008 - Theratechnologies (TSX:TH) announced today that new data from its first 52-week Phase 3 study testing tesamorelin in HIV-associated lipodystrophy were presented as a poster (Poster Number 943) on February 4, 2008 at the 15th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts.
The purpose of the extension phase of the study was to evaluate the safety profile at 52 weeks, which demonstrated that tesamorelin was overall well tolerated. In general, at 52 weeks, tesamorelin showed a clinically significant decrease in triglyceride levels with maintenance of cholesterol levels within normal range. Furthermore, tesamorelin, at 52 weeks, had no clinical effect on glucose parameters and resulted in improved body composition including the selective maintenance of VAT loss without affecting subcutaneous adipose tissue and limb fat. As a final note, the reduction of visceral adipose tissue was significant in both males and females at 52 weeks compared to baseline levels.
HIV-associated Lipodystrophy HIV-associated lipodystrophy is characterized by a change in the distribution of adipose tissue (fat containing tissue), dyslipidemia and glucose intolerance. Visceral adipose tissue accumulation with its concomitant metabolic profile is known to be a risk factor for cardiovascular diseases. The changes in fat distribution include visceral fat accumulation and/or loss of subcutaneous fat, generally in the limbs and in the face. There is no approved treatment available for the accumulation of visceral fat found in patients with HIV-associated lipodystrophy.
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 impact of certain clinical results 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 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. 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 Executive Director, IR & Communications Theratechnologies Inc. Phone: 514 336-7800, ext. 205 firstname.lastname@example.org@theratech.com>
Posted: February 2008