Mesoblast Limited Entered Into An MoU To Support Marketing Approval of Revascor

  • Mar 27, 2019 AEDT
  • Team Kalkine
Mesoblast Limited Entered Into An MoU To Support Marketing Approval of Revascor

Mesoblast Limited inked a Memorandum of Understanding with International Center for Health Outcomes and Innovation Research (InCHOIR) located at the Icahn School of Medicine at Mount Sina to support their confirmatory clinical trial with the use of Mesoblast’s product candidate Revascor (MPC-150-IM) for reduction of gastrointestinal bleeding in LVAD patients.

Positioned as a global leader in cellular medicines for inflammatory diseases, Mesoblast Limited (ASX: MSB) has developed a tier 1 product candidate MPC-150-IM for the treatment of both advanced and end-stage chronic heart failure. In the Phase 2 Trial, MPC-150-IM has shown the favourable result in reducing gastrointestinal bleeding episodes faced by the end-stage heart failure patients implanted with a left ventricular assist device (LVAD).

In today’s release, Professor of Department of Cardiac Surgery at the University of Michigan Dr Frank Pagani stated that the recurring occurrence of Gastrointestinal bleeding is a notable life-threatening complication in LVAD implanted patients. It has been observed that it occurs in about 20-40% of recipients in the initial six months of their implantation, thereby leading to recurrent hospitalisations and compromising the quality of life.

Dr Frank Pagani was a co-principal investigator of the recently completed 159-patient study in Phase 2 Trial for which International Center for Health Outcomes and Innovation Research (InCHOIR) served as the central coordinating and data management arm. Under this study, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) therapy Revascor showed 76% reduction in GI bleeding events which was further associated with a 65% reduction in hospitalisations, as per the company’s information.

Dr Frank Pagani further believes that these clinical results would identify a therapeutic approach that could greatly benefit these patients in reduced major bleeding episodes and related hospitalisations by using Mesoblast’s MPC therapy Revascor.

Mesoblast’s MPC therapy Revascor started its pilot trial with 30-patients in 2014 which resulted in a 70% reduction in GI bleeding events. The Pilot Trial then became the basis of FDA Regenerative Medicine Advanced Therapy (RMAT) that was granted for Revascor in 2017.

Currently, the product candidate is into the placebo-controlled Phase 3 trial which has registered approximately 600 patients to evaluate a single dose of MPC-150-IM in Class II/III chronic heart failure patients across multiple sites in North America.

United States Food and Drug Administration (FDA) told Mesoblast that reduction in GI bleeding and related hospitalisations are a clinically meaningful outcome that can support marketing approval. The company, therefore, plans to meet with the FDA in the upcoming quarter to discuss an approval pathway for Revascor under its existing RMAT designation which will provide eligibility for priority review and accelerated approval.

The senior executives of InCHOIR’s Department of Population Health Science & Policy expressed that the commitment to work on a new trial demonstrates the institute’s shared vision to confirm its observations of a reduction in major gastrointestinal bleeding episodes and associated hospitalizations in LVAD patients as part of the pathway of introducing this therapy into real-world clinical practice.

MSB stock last traded at $1.385, down 1.071%, on 27 March 2019. Over the past 12 months, the stock has declined by 10.26% despite the positive price change of 34.62% recorded in the past three months.

Also Read: Mesoblast Limited Highlighted Its Commercial And Development Plans At Biotech Showcase 2019


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