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news.Theratechnologies 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.
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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.
About Ibalizumab
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.