MONTREAL, QUEBEC--(Marketwire - Sept. 6, 2011) - Theratechnologies Inc. (TSX:TH)(NASDAQ:THER) announced today that it has initiated the patient screening process of its phase 2 clinical trial investigating tesamorelin for the treatment of muscle wasting in patients suffering from chronic obstructive pulmonary disease (COPD). This follows the investigator meeting, which took place in Montreal, Quebec, Canada, on August 27, 2011. The objective of the study is to evaluate the effects of two doses of a new formulation of tesamorelin on lean body mass (LBM), patient functionality and quality of life.
"I am pleased that we have launched our COPD clinical program as planned and on schedule, in our pursuit of a second indication for our lead compound tesamorelin," said Mr. John-Michel T. Huss, President and Chief Executive Officer. "There are millions of patients worldwide suffering from COPD-associated muscle wasting and if successful, we will be able to address a currently unmet medical need," concluded Mr. Huss.
Based on available market and industry data, the Company estimates that in 2010 there were approximately 3.1 million COPD patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage II or III only, suffering from a muscle wasting condition with a body mass index under 25, when including the United States, France, Germany, Italy, Spain, United Kingdom and Japan.
The COPD clinical program is a multi-center, double-blind, randomized, placebo-controlled phase 2 clinical trial. It is now open for the screening and enrollment of eligible patients and it will be conducted in up to 25 centers in the United States and Canada. The study will examine the safety and efficacy of a daily administration of either a 2 mg or 3 mg dose of a new formulation of tesamorelin for a period of 26 weeks. The primary endpoint is an increase in LBM as measured by dual-emission X-ray absorptiometry (DXA). The study will also assess the effect of tesamorelin on patient functionality and quality of life. This will include a six-minute walking distance test, quadriceps muscle strength and a St. George's Respiratory Questionnaire. The Company expects to enroll approximately 200 patients in the study and its results are expected before the end of 2012.
Tesamorelin is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces growth hormone production in a specific and physiological manner. The anabolic properties of tesamorelin have led Theratechnologies to pursue its development in muscle wasting in patients with COPD as a second indication for the compound. A previously completed phase 2 trial in stable ambulatory COPD patients demonstrated a statistically significant increase in LBM.
"Muscle-wasting in patients with COPD represents an important medical concern. If we can demonstrate that tesamorelin can reverse muscle loss, it could go a long way toward improving functionality of these patients in their daily activities and more generally, their quality of life," stated Dr. Richard Casaburi, Professor of Medicine at the UCLA School of Medicine and Medical Director of the Rehabilitation Clinical Trials Center of the Los Angeles Biomedical Research Institute. Dr. Casaburi is the Lead Investigator for the COPD clinical program.
About COPD-Associated Muscle Wasting
COPD is characterized by progressive airflow obstruction due to chronic bronchitis or emphysema, two commonly coexisting lung diseases. Many COPD patients are affected by a systemic manifestation which may lead to muscle wasting. Muscle wasting, a decrease or thinning of the muscle mass, is associated with several abnormalities, including impaired exercise capacity and functioning, and decreased muscle strength. Muscle wasting is an independent predictor of a COPD patient's functional deterioration and mortality, and is a common symptom in patients with moderate to severe COPD.
About Theratechnologies
Theratechnologies (TSX:TH)(NASDAQ:THER) is a specialty pharmaceutical company that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. For more information about Theratechnologies, please visit www.theratech.com. Additional information, including the Annual Information Form and the Annual Report, is also available on SEDAR at www.sedar.com and on the Securities and Exchange Commission's website at www.sec.gov.
Forward-Looking Information
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation, which statements may contain such words as "may", "would", "could", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" and similar expressions. This forward-looking information includes, but is not limited to, information regarding that the clinical program outlined in treating patients with muscle wasting in COPD will be successful in building lean body mass and that our assumptions of the market size are accurate.
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 Theratechnologies' control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include, but are not limited to, that tesamorelin will build lean body mass for patients with muscle wasting in COPD, that clinical trials will be completed on schedule and on budget, that no serious adverse events negatively impact our business, that physicians desire a treatment for those patients with muscle wasting in COPD, that relations with third-party suppliers of tesamorelin will be conflict-free and that such third-party suppliers will have enough capacity to manufacture and supply tesmorelin to meet its demand and on a timely-basis and that our estimated market size is accurate. These risks and uncertainties include, but are not limited to, the risk that the results of the administration of tesamorelin for muscle wasting in COPD patients differ from those in HIV-patients suffering from excess abdominal fat associated with lipodystrophy, that the clinical trials take longer than expected and are more costly, that unexpected serious adverse events impact negatively our business, that physicians do not perceive a need to treat these patients, that our third-party manufacturers will be unable to supply tesamorelin for these studies without impacting our other programs and that the market size is smaller than anticipated.
Theratechnologies refers potential investors to the "Risks and Uncertainties" section of its Annual Information Form (AIF) dated February 22, 2011. The AIF is available at www.sedar.com and at www.sec.gov under Theratechnologies' 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 Theratechnologies' expectations as of that date.
Theratechnologies undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
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