Theratechnologies Announces Completion of Enrollment for Phase III Ibalizumab Trial
MONTREAL, QUEBEC--(Marketwired - April 27, 2016) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) is pleased to announce that it has been notified by its partner, TaiMed Biologics, Inc., that the enrollment for the Phase III study of ibalizumab, in combination with optimized background regimen (patients' current therapy), for patients infected with multi-drug resistant HIV-1 has been completed as of April 27, 2016. The enrollment in the US has reached 36 patients, exceeding the minimum of 30 patients proposed by the United States Food and Drug Administration (FDA). The last patient enrolled in the study has entered the initial 7-day control period. On Day 7, ibalizumab will be administered and the primary end point will be assessed 7 days after initiation of ibalizumab on Day 14. The study will continue for a total of 24 weeks of treatment with ibalizumab.
This open label, single arm Phase III study is the last clinical trial required by the FDA to complete the BLA submission. The primary end point is the proportion of patients achieving a viral load reduction of at least 0.5 log10 at Day 14. Top-line results of the primary end point should be available by the end of May 2016.
Ibalizumab is a humanized monoclonal antibody for the treatment of HIV-1 infection. The antibody is a novel CD4-directed HIV entry-inhibitor currently in a late stage Phase III clinical trial.
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy ageing and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com.
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, the timing to obtain the top-line results of the primary end point.
Forward-looking statements are based upon a number of assumptions and are 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, the following: no delay will occur in the study, no serious adverse effect will occur using ibalizumab and the FDA will not request additional studies.These risks and uncertainties include, but are not limited to, the risk that top-line results do not meet the primary end point, the FDA requires additional studies and delays occur in the conduct of the study.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 24, 2016 available on SEDAR at www.sedar.com. 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.
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