MONTREAL, CANADA--(Marketwired - June 9, 2015) - Theratechnologies (TSX:TH) today announced a collaboration with the Massachusetts General Hospital (MGH) that will evaluate the safety and efficacy of tesamorelin in the treatment of HIV-infected patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Tesamorelin is not indicated for either of these conditions. Theratechnologies'role will consist of supplying tesamorelin to the MGH.
Funding for the clinical trial has been awarded by the U.S. National Institutes of Health (NIH) following the completion of a clinical trial assessing the efficacy of tesamorelin on reducing liver fat in HIV-infected patients with lipodystrophy, results from which were published in the July 2014 edition of the Journal of the American Medical Association. The NIH grant will allow Drs. Steven Grinspoon of the MGH and Colleen Hadigan of the National Institute of Allergy and Infectious Disease, part of NIH, to pursue research on tesamorelin in HIV-infected patients with fatty liver disease. The study will enroll a total of 60 HIV-infected patients with NAFLD/NASH, who will receive either tesamorelin (2mg/day) or a placebo.
While NAFLD can be benign, it can develop into a serious condition leading to liver failure. NASH is the most severe form of fatty liver disease and can cause significant damage to liver cells including liver cirrhosis. It is not known if tesamorelin is safe or effective for these conditions.
About Theratechnologies
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and improved quality of life. Further information about Theratechnologies is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com
Forward Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management's belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", "would", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding: the supply of tesamorelin by the Company to the MGH, the enrollment of patients to conduct the study and the execution and conclusion of the study by the MGH.
Forward-looking statements are based upon a number of assumptions and 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, the following: the Company will be able to supply tesamorelin when required by the MGH, the MGH will succeed in recruiting the desired number of patients and pursue the study until completion, the NIH will not suspend or withdraw its grant and positive results will emanate from this study.
These risks and uncertainties include, but are not limited to, the risk that the Company is unable to supply tesamorelin or delays in such supply occurs, the risk that the recruitment of patients is not successful or delayed thereby resulting in the study being halted or delayed, the risk that serious adverse events from the use of tesamorelin are reported causing the study to be halted and the risk that the NIH suspends or withdraw its financing for the study.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 25, 2015 available at www.sedar.com and at www.theratech.com for additional risks regarding the Company and its operation which could have an adverse effect on the supply of tesamorelin for this study or on the study itself. 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 statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.
We undertake 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.
Contact Information:
514-913-1957