MONTREAL, CANADA--(Marketwire - June 12, 2009) - Theratechnologies (TSX: TH) announced today that results from a pharmacokinetic/pharmacodynamic (PK/PD) evaluation of tesamorelin were presented as a poster (Poster number: P3-641) at the Endocrine Society's 91st Annual Meeting in Washington D.C. Tesamorelin is an analogue of the growth hormone releasing factor evaluated for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
The poster outlined the results of two Phase 1 studies performed to determine the PK/PD profiles of tesamorelin after single and multiple administrations of 2 mg of tesamorelin once daily for 14 consecutive days, in healthy volunteers and HIV-positive patients receiving a stable antiretroviral regimen. The results showed that tesamorelin's PK/PD profiles were generally similar in both groups and suggest that there is a minimal impact on tesamorelin's PK parameters and on the induction of the insulin-like growth factor (IGF-1) when tesamorelin is given to HIV-positive patients on antiretroviral therapy.
Levels of IGF-1 at baseline were within normal range and comparable in both groups (healthy: 175 ng/mL; HIV+: 164 ng/mL). After 14 days of daily injection, a similar increase was observed in healthy volunteers and in HIV-positive patients (115% and 121%, respectively, compared to baseline). In both studies, the extent of absorption (AUC) and the maximal concentration (Cmax) were similar (approximately 700 pgÃ¯Â¿1/2h/mL and 2400 pg/ml for AUC and Cmax, respectively). The half-life of tesamorelin ranged between 13 to 38 minutes in both healthy volunteers and HIV-positive patients.
The poster presented is now available on Theratechnologies' website at www.theratech.com
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.
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the growth hormone releasing factor.
In 2008, Theratechnologies completed its Phase 3 clinical program evaluating tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy. The Company has also entered into a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States.
With a NDA recently filed with the US authorities, Theratechnologies' growth strategy is firmly focused on the development of tesamorelin, in the United States and in other potential lipodystrophy markets, as well as through additional clinical programs.
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 beneficial nature of tesamorelin for patients. Words such as "will", "may", "could", "should", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or variations of them 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 the results from treatment with tesamorelin may vary from one patient to another.
The Company refers potential investors to the "Risks and Uncertainties" section of its Annual Information Form (the "AIF") dated February 24, 2009. The AIF is available at http:/www.sedar.com/ under the Company's public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements.
Forward-looking information reflects current expectations regarding future events and speaks only as of the date of this press release and represents the Company's 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.