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Theratechnologies: Last Patient Treated in the Confirmatory Study Testing Tesamorelin in HIV-Associated Lipodystrophy

Posted on: Monday, 14 April 2008, 09:01 CDT

Theratechnologies (TSX: TH) announced today that the last patient has completed 26 weeks of treatment in the confirmatory Phase 3 trial testing tesamorelin in HIV-associated lipodystrophy. The Company now expects to be in a position to present top-line, 26-week results of this confirmatory Phase 3 trial by the end of the first half of 2008.

"We are extremely pleased to have completed our confirmatory Phase 3 trial on schedule," said Dr. Christian Marsolais, Vice President, Clinical Research of Theratechnologies. "Data from this confirmatory Phase 3 trial are very important as they will allow us to move forward with the preparation of the documentation required to submit a New Drug Application (NDA) for tesamorelin in HIV-associated lipodystrophy to the US Food and Drug Administration (FDA) by year end," added Dr. Marsolais.

The confirmatory Phase 3 trial is a 400-patient, multi-center, double-blind, randomized, placebo-controlled study conducted in 48 centers in North America and Europe. It is designed to confirm the results of the first Phase 3 trial by examining the safety and efficacy of a daily administration of 2 mg of tesamorelin for 26 weeks. The primary endpoint is a reduction of visceral adipose tissue. In August 2006, the protocol for this confirmatory Phase 3 trial was reviewed by the FDA under the Special Protocol Assessment process.

"I am very positive and enthusiastic about this important milestone as it signals the completion of our Phase 3 program with tesamorelin in HIV-associated lipodystrophy," commented Mr. Yves Rosconi, President and CEO of Theratechnologies.

On October 1st, 2007, Theratechnologies announced positive 52-week results of the first Phase 3 clinical trial, evaluating the long-term safety profile of tesamorelin in patients with HIV-associated lipodystrophy.Those results showed that tesamorelin is well tolerated and confirmed tesamorelin's efficacy as patients on treatment for 52 weeks lost 18% of their visceral adipose tissue compared to baseline.

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 has recently been shown to be a risk factor for cardiovascular diseases in HIV seropositive patients. The changes in fat distribution in lipodystrophy patients 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 Information

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 timing to present top-line 26-week results from the confirmatory Phase 3 trial and the filing of our NDA with the FDA. 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 delays that may occur in compiling and analyzing the data resulting from the confirmatory Phase 3 trial and the negative results that the confirmatory Phase 3 clinical study may yield. 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 past results obtained from first Phase 3 clinical study will be repeated, that the time required to analyze and report the results of the Company's confirmatory Phase 3 clinical study will be consistent with past timing and the current relationship with the Company's third party suppliers of services or products will remain good.

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 Executive Director, IR & Communications 514-336-7800, ext. 205 514-336-7242 (FAX) www.theratech.com

SOURCE: Theratechnologies Inc.

Source: MARKET WIRE

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