Mesoblast Ltd ADR (MESO)

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Circulation Research Special Article Highlights Potential Of Mesoblast Cell Therapy In Treatment Of Advanced Heart Failure

Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that premier cardiovascular journal Circulation Research has published a Special Article highlighting the important potential clinical benefits of Mesoblast’s allogeneic mesenchymal precursor cell (MPC) technology platform as immunotherapy in patients with advanced chronic heart failure.
The Special Article highlighted that cardiac inflammation drives heart failure progression, and concluded that based on preclinical and Phase 2 clinical data there is a biologic rationale for the use of Mesoblast’s MPCs in targeting this inflammatory process in order to improve heart failure outcomes.

The manuscript, titled ‘Phase 3 DREAM-HF Trial of Mesenchymal Precursor Cells in Chronic Heart Failure; A Review of Biological Plausibility and Implementation of Flexible Clinical Trial Design,’ was requested by the journal’s Editor-in-Chief. Its authors include the Phase 3 trial’s co-principal investigators, Dr Emerson Perin, Texas Heart Institute, and Dr Barry Greenberg, University of California, San Diego Healthcare System. The article can be accessed at https://doi.org/10.1161/CIRCRESAHA.119.314951.

The ongoing, placebo-controlled double-blind Phase 3 trial of Mesoblast’s heart failure cellular medicine Revascor, comprising 150 million MPCs, is evaluating the immunotherapy for reduction of heart failure-related hospitalizations and terminal cardiac events in patients with advanced heart failure. The events-driven trial completed enrollment of 566 patients in February 2019, and was previously successful in a pre-specified interim futility analysis of the primary efficacy endpoint in the first 270 patients.

Revascor is also being evaluated to prevent mucosal bleeding in end-stage chronic heart failure patients with a Left Ventricular Assist Device (LVAD) and recently received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for this indication. Mesoblast is in discussions with the FDA regarding a potential approval pathway under the product’s existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition.

https://www.globenewswire.com/news-release/2019/07/25/1887815/0/en/Circulation-Research-Special-Article-Highlights-Potential-Of-Mesoblast-Cell-Therapy-In-Treatment-Of-Advanced-Heart-Failure.html