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news.Mesoblast has obtained the European Medicines Agency (EMA) approval to start a Phase 2 trial to Europe to evaluate Revascor in combination with angioplasty and stent procedures as a preventive measure for heart failure after a major heart attack.
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The Phase 2 trial – Allogeneic Mesenchymal precursor cell Infusion in myoCardial Infarction (AMICI) – is expected to initially enroll patients at multiple European sites, including in the UK The Netherlands and Belgium.
The trial aims to evaluate the safety and efficacy at six months in heart attack patients who will receive either Revascor at one of two doses or placebo.
Durability of effect will additionally be monitored for up to 36 months.
Mesoblast CEO Silviu Itescu said if the preclinical results are reproduced in this trial, they will have a product that will make a significant impact on the lives of patients after a debilitating heart attack.
"Mesoblast has a strategic partnership with US biopharmaceutical company Cephalon to commercialize Revascor for the broad treatment of cardiovascular diseases," Itescu said.