Date: 2014-08-06
Type of information: Collaboration agreement
Compound: Mesenchymal Precursor Cells (MPCs)
Company: Mesoblast (Australia) National Heart, Lung and Blood Institute, NIH (USA)
Therapeutic area: Cardiovascular diseases - Regenerative medicine
Type agreement: collaboration
Action mechanism:
Disease: congestive heart failure, advanced heart failure
Details: * On August 6, 2014, Mesoblast announced the signing of an agreement with the United States National Institutes of Health\'s (NIH) National Heart, Lung and Blood Institute to collaborate on a trial using Mesoblast\'s proprietary adult stem cell therapy to treat patients with advanced heart failure requiring an implantable left ventricular assist device (LVAD) to maintain circulatory support. The National Institute of Neurological Disorders and Stroke, part of the NIH, and the Canadian Institutes for Health Research are also supporting this trial. The key objectives of using Mesoblast\'s Mesenchymal Precursor Cells (MPCs) in end-stage heart failure patients are to improve heart muscle function sufficiently to reduce the need for LVAD support, and to reduce the long-term complications of LVAD implantation which result in recurrent hospitalizations. The 120-patient study, to be conducted by the NIH-funded Cardiothoracic Surgical Trials Network, will evaluate the effects of a single injection of 150 million allogeneic, or off-the-shelf, MPCs into the hearts of patients with advanced heart failure. This new study builds on the findings published in the June issue of the American Heart Association journal Circulation of a double blind study in 30 patients which showed the potential benefits of a single intra-cardiac injection of 25 million MPCs in advanced heart failure and LVAD implantation. The trial is a double-blind, placebo-controlled, 2:1 randomized design that is being conducted in more than 20 sites across the United States. The primary efficacy endpoint of the study is the number of temporary weans from LVAD tolerated over 12 months. Additionally, the study will evaluate patient survival and re-hospitalization over 12 months. The 150 million MPC dose selected for direct cardiac injection in this second study is the same dose that is currently being evaluated in an ongoing Phase 3 trial of approximately 1,700 patients with NYHA Class II-III heart failure. The Phase 3 trial, sponsored by Mesoblast\'s development and commercial partner, Teva Pharmaceutical Industries Ltd., is actively enrolling patients across multiple sites in the United States. The primary efficacy endpoint of that 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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