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ARTICLE | Clinical News

Revascor mesenchymal precursor cells: Interim Phase II data

January 17, 2011 8:00 AM UTC

Interim data from the ongoing, single-blind, placebo-controlled, dose-escalation, U.S. Phase II HF-AB002 trial in 60 patients showed that single injections of 25, 75 and 150 M Revascor plus standard of care (SOC) met the primary endpoint with no cell-related adverse events observed in any of the 45 patients who received Revascor at a mean follow-up of 18.5 months. Revascor plus SOC also met the secondary endpoints of significantly reducing the proportion of patients who developed any severe adverse cardiac event (44.4% vs. 93.3%, p=0.001) and the proportion of patients who developed any MACE vs. SOC alone (6.7% vs. 40%, p=0.005). Additionally, Revascor plus SOC significantly reduced the overall monthly event rates of severe adverse cardiac events and of MACE by 54% and 84%, respectively, vs. SOC alone (p=0.03 and p=0.01, respectively).

Revascor plus SOC non-significantly reduced death from cardiac causes vs. SOC alone (0% vs. 13.3%, p=0.059), and non-significantly reduced the overall monthly rates of cardiac-related hospitalizations and heart failure hospitalizations by 48% and 61%, respectively, vs. SOC alone (p=0.07 and p=0.13, respectively). Data were presented at the J.P. Morgan Healthcare Conference in San Francisco. The partners plan to request an end of Phase II meeting with FDA by year end. ...