ORLANDO, Florida and MELBOURNE, Australia, November 14, 2011 /PRNewswire/ --
- Revascor™, Mesoblast's proprietary Mesenchymal Precursor Cell (MPC) product for cardiovascular diseases, was safe and well-tolerated at all doses, with no clinically relevant immune responses to donor cells
- Revascor™ therapy significantly reduced cardiac mortality and major adverse cardiac events (MACE) in patients with congestive heart failure over a mean follow-up of 22 months
- Highest dose of Revascor™ completely prevented any episodes of heart failure hospitalization over 18 months of follow-up
- Clinical improvement was associated with evidence of remodeling (reduction in heart volumes) and improvement in functional capacity (increased walking distance), which are key parameters in congestive heart failure
- Revascor™ anticipated to progress to Phase 3 trial in first half of 2012
Regenerative medicine company Mesoblast Limited (ASX:MSB; OTC ADR:MBLTY) today announced positive Phase 2 heart failure trial results of its allogeneic, or off-the-shelf, adult stem cell product Revascor™ after all patients had completed a minimum follow-up of 12 months, and a mean follow-up of 22 months. The Phase 2 trial results were presented at the American Heart Association annual meeting in Orlando, Florida, by the trial's independent principal investigator Dr Emerson C. Perin, Director of Research in Cardiovascular Medicine and Medical Director, Stem Cell Center, Texas Heart Institute in Houston.
MPC treatment pooled across all doses resulted in significant reduction in cardiac mortality, and at the highest dose resulted in complete prevention of heart failure hospitalization events. Mesoblast expects that these outcomes will be central to the primary endpoint of a Revascor™ Phase 3 trial for product regulatory approval by the United States Food and Drug Administration (FDA).