2015-07-15

NEW YORK and MELBOURNE, Australia, July 14, 2015 (GLOBE NEWSWIRE) — Mesoblast Limited (ASX:MSB; USOTC:MBLTY) today announced that Phase 2 trial results of its cell therapy product candidate for the treatment of congestive heart failure (CHF) have been published in the latest edition of Circulation Research. The results were published as an “online first” article ahead of full print in this peer-reviewed, high-impact journal of the American Heart Association.Transendocardial injections of allogeneic MPCs into the hearts of patients with either ischemic or non-ischemic heart failure due to left ventricular systolic dysfunction were feasible and safe, with a similar incidence of adverse events across all control and treatment groups.Treatment of patients with allogeneic MPCs was not associated with any clinically significant immune response.Secondary Efficacy EndpointsPatients treated with the highest dose, MPC 150M, showed the greatest improvement in left ventricular remodeling compared to controls; this was evidenced by significant reductions in Left Ventricular End Systolic Volume (LVESV), p equals 0.015, and Left Ventricular End Diastolic Volume (LVEDV), p equals 0.02, at month 6 post treatment relative to controls.Parallel improvements in both LVESV and LVEDV in the MPC-treated patients may have accounted for the observed non-significant changes in ejection fraction.Patients treated with the highest dose, MPC 150M, showed the greatest improvement in functional exercise capacity compared to controls (6MTW: p equals 0.062) at month 12 post treatment.Major Adverse Cardiovascular Events (MACE)In a post-hoc analysis after all patients had completed 36 months of follow up, treatment with MPC 150M was shown to be associated with a significantly lower incidence of HF-MACE events compared to the control group (0% vs 33% HF-MACE by Kaplan-Meier, p equals 0.026 by log-rank).  Lead author and investigator Dr Emerson C. Perin, Director, Research in Cardiovascular Medicine and Medical Director of the Stem Cell Center at the Texas Heart Institute, said: “The findings from this trial are very encouraging and suggest that a high-dose of Mesoblast’s allogeneic cell-based therapy may decrease major clinical events associated with progressive heart failure for at least three years, including repeated hospitalizations or death.  Julie Meldrum

Global Head of Corporate Communications

Mesoblast Limited

T: +61 (0) 3 9639 6036

E: julie.meldrum@mesoblast.com

Source: Globenewswire Public
Congestive Heart Failure Phase Trial Results Published In Circulation Research

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