Theratechnologies Presents Additional Results from its Tesamorelin Phase 3 Studies at the 10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV
MONTREAL, Nov. 6, 2008 – Theratechnologies (TSX:TH) announced today that new 26-week data from a combined analysis of both its Phase 3 clinical trials testing tesamorelin in HIV-associated lipodystrophy were presented as a poster (Poster Number 19) at the 10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, in London, England. The results of the combined Phase 3 trials presented at this HIV-focused workshop indicate that a daily administration of 2 mg of tesamorelin is beneficial in reducing visceral adipose tissue (VAT) in HIV-infected patients regardless of the type of antiretroviral therapy (ART) regimen used to treat the HIV infection.
The combined trials represented 816 patients who were treated with the following ART regimens: NRTI/PI 45%, NNRTI/NRTI 33%, NNRTI/NRTI/PI 10%, NRTI monotherapy 5% with the remaining other combinations representing 7%. The average time since initial diagnosis of HIV infection was 13 years with the average duration of ART therapy being 4.5 years. Patients in these studies, on average, had been diagnosed with lipodystrophy syndrome for 3.9 years. Overall the VAT decreased from baseline by 13% in tesamorelin-treated patients after 26 weeks of treatment (p<0.001 vs. placebo) while the placebo group increased VAT by 2.3% overall from baseline. Across different ART regimens, no clinically significant difference was observed in either subcutaneous adipose tissue (SAT) or limb fat levels, while lean body mass increased regardless of ART therapy. In this combined analysis, overall triglycerides increased by 10% in the placebo group while the treated group had a decrease of 2.4% (p=0.001 vs. placebo). The combined data demonstrated that VAT reduction occurred in HIV-infected patients irrespective of the ART therapy.
“Fortunately, with the improved care that HIV patients are obtaining to control the HIV virus, patients are living longer; however, with increasing longevity, it is becoming important to treat HIV-associated diseases related the various ART treatments, such as the excess abdominal fat associated with lipodystrophy,” said Dr. Christian Marsolais, Vice President, Clinical Research and Medical Affairs at Theratechnologies. “It is encouraging that, in these studies, tesamorelin is effective regardless of ART therapy and this could be very promising for combating the effects of excess abdominal fat in HIV-patients with lipodystrophy,” Dr. Marsolais continued.
“The observation that almost all patients were treated with NRTIs and that over half were treated with PIs suggests that these medications are the cornerstones of HIV therapy today,” commented Mr. Yves Rosconi, President and CEO of Theratechnologies. “These data continue to build a strong product profile for tesamorelin which could be beneficial for the US regulatory submission and for the development of our regulatory strategies outside of the US,” concluded Mr. Rosconi.
Detailed 26-week data from the first Phase 3 trial were published in the New England Journal of Medicine, on December 6, 2007 and top line 26-week results from the confirmatory Phase 3 trial were disclosed, in June 2008. Long term safety results from the first Phase 3 study were published in the Journal of the International AIDS Society, on September 2, 2008.
About HIV-Associated Lipodystrophy Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a 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, which is concluding a confirmatory Phase 3 clinical trial for a serious metabolic disorder involving excess abdominal fat in HIV patients with 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 effectiveness of tesamorelin and its capacity to treat excess abdominal fat in HIV-patients with lipodystrophy and the impact of the data on tesamorelin for regulatory submission in the United States of America. 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 HIV patients with lipodystrophy having excess abdominal fat experience results that may differ from those indicated herein, the risk that the Company is unable to file a New Drug Application (NDA) with the US regulatory authorities or, if such filing occurs, that tesamorelin does not receive regulatory approval. 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, but are not limited to, that HIV-patients with lipodystrophy having excess abdominal fat will react positively to the administration of tesamorelin, that the Company will file a NDA with US regulatory authorities and that tesamorelin will be approved as a drug by the applicable regulatory authorities. 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. Furthermore, the forward-looking information reflects current expectations regarding future events and speaks only as of the date of release of this press release and represents Theratechnologies’ expectations as of that date. 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 firstname.lastname@example.org@theratech.com>
Posted: November 2008