Theratechnologies Reports on Positive Body Image Parameters at the International AIDS Conference
MONTREAL, CANADA–(EMWNews – Aug. 4, 2008) – Theratechnologies (TSX:TH) today announced positive data related to body image for patients treated with tesamorelin in both its first and confirmatory Phase 3 clinical trials, in two poster presentations at the XVII International AIDS Conference in Mexico City, Mexico. Body image parameters are considered an important secondary endpoint and a clinical benefit of both Phase 3 studies. The Company will also sponsor a symposium entitled “Body Fat Changes and Metabolic Complications in the General Population and in HIV” at the Conference.
“With the Special Protocol Assessment in hand, and two positive large Phase 3 trials that met their primary and important secondary endpoints, the tesamorelin program is steadily progressing towards a NDA submission with a targeted market approval by the end of 2009,” commented Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies.
“At a recent conference organized by the American Heart Association and the American Academy of HIV Medicine, it was emphasized that HIV-positive patients who adhered to their HIV medications had fewer complications than patients who took their antiretroviral regimens intermittently,” said Dr. Christian Marsolais, Vice President, Clinical Research of Theratechnologies. “Since stress related to body image may actually lead patients to discontinue or alter their HIV treatments, reducing this stress could be very beneficial,” explained Dr. Marsolais.
First Phase 3 Trial: Body Image Parameters at 52 Weeks
The first poster was authored by Dr. Ralph Turner, Vice President and Senior Research Investigator of Phase V Technologies, and collaborators, and describes the new positive results of the body image parameters for the first Phase 3 study at 52 weeks. The poster is entitled, “Long-term Impact of Tesamorelin (TH9507), a Growth Hormone-Releasing Factor Analogue, on Body Image Parameters in HIV-Infected Patients with excess Abdominal Fat” (poster Number: THPE0810). Patients who continued treatment with 2mg of tesamorelin for a total of 52 weeks in the first Phase 3 study experienced sustained improvements in belly and body appearance distress as well as patient-reported belly profile (p less than 0.05 compared to baseline). Alternatively, improvements in these parameters seen at Week 26 of treatment were lost in patients who were crossed over to placebo at Week 26. As was observed with visceral adipose tissue (VAT), the primary endpoint of the study, improvements in belly image, an important secondary endpoint and a clinical benefit of the study, were sustained for those patients treated over a 52-week period. Phase V Technologies is an independent company responsible for evaluating body image parameters in Theratechnologies’ pivotal Phase 3 clinical trials.
Confirmatory Phase 3 Trial: Body Image Parameters at 26 Weeks
The second poster was authored by Dr. Julian Falutz, Director, HIV Metabolic Clinic, Montreal General Hospital, Assistant Professor, McGill University Medical School, and Lead Investigator for Canada and reviews the positive confirmatory Phase 3 results, previously disclosed by the Company, for patients treated with 2mg of tesamorelin over 26 weeks. The poster is entitled, “Results from the 26-Week Confirmatory, Phase 3 Trial of Tesamorelin (TH9507), a Growth Hormone-Releasing Factor Analogue, in HIV Patients with Excess Abdominal Fat: A Multi-center, Double-Blind, Placebo-Controlled Study with 404 Randomized Patients” (poster Number: LBPE1156). The poster reviews the positive top-line previously disclosed data regarding efficacy and safety of tesamorelin. As a summary, VAT significantly decreased without affecting SAT, belly image was significantly improved, and improvements were seen in triglyceride levels without affecting glucose parameters. These positive data confirm previous Phase 3 data suggesting that tesamorelin may be beneficial for the treatment of HIV patients with lipohypertrophy.
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.
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.
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 and the capacity of the Company to file an NDA and the likelihood that it obtains market approval for its tesamorelin. 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 risk that the Company encounters problems in preparing the NDA submission and the risk that the FDA does not approve tesamorelin as a drug to treat HIV-associated lipodystrophy. 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, that the Company will not encounter any problem in preparing its NDA submission and that the FDA will accept the NDA submission and approve tesamorelin for the treatment of HIV-associated lipodystrophy.
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.
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