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FDA Clears Commencement Of Mesoblast Ltd's PHASE 3 Chronic Heart Failure Trial Using Cells


Wednesday, 30 Oct 2013 11:00pm EDT 

Mesoblast Ltd announced that the United States Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) filing made by Mesoblast’s development and commercial partner Teva Pharmaceutical Industries Ltd to commence a Phase 3 trial in patients with chronic congestive heart failure using Mesoblast's Mesenchymal Precursor Cells (MPCs). The IND was cleared by the FDA within the minimum 30-day period following submission, and patient recruitment is expected to begin shortly. The multi-center trial, which will be conducted by Teva, is planned to enrol approximately 1,700 patients and includes two interim analyses of efficacy and/or safety. The clinical protocol was designed after initial consultation with both the FDA and the European Medicines Agency. The Phase 3 trial design is a double-blinded, 1:1 randomized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of heart failure patients with New York Heart Association (NYHA) class II or III disease and an ejection fraction ≤ 40%. The primary efficacy endpoint of the trial is a time-to-first event analysis of heart failure-related Major Adverse Cardiac Events (HF-MACE), defined as a composite of cardiac related death or resuscitated cardiac death, or non-fatal decompensated heart failure events. 

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