Mesoblast, Icahn Medical School Sign MOU For Intestinal Bleeding Trial.
NEW YORK, N.Y., March 26 -- Australian stem cell company Mesoblast Limited (NASDAQ:MESO) and the International Center for Health Outcomes and Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai have signed a Memorandum of Understanding (MOU) to conduct a confirmatory clinical trial using Mesoblast's product candidate Revascor (MPC-150-IM) for reduction of gastrointestinal (GI) bleeding in end-stage heart failure patients implanted with a left ventricular assist device (LVAD).
Gastrointestinal bleeding episodes are a major life-threatening complication of LVAD implants that occur in 20-40 percent of recipients in the first six months, resulting in recurrent hospitalizations and compromising quality of life.
"Confirmation of our previous observations that Mesoblast's cell therapy reduced major bleeding episodes and related hospitalizations would identify a therapeutic approach that could greatly benefit these patients," said cardiac surgeon of the University of Michigan, co- principal investigator of the recently completed 159-patient study coordinated by InCHOIR.
In a 30-patient pilot trial, Mesoblast's allogenic mesenchymal precursor cell (MPC) therapy Revascor showed a 70 percent reduction in GI bleeding events.
This formed the basis for the successful Regenerative Medicine Advanced Therapy (RMAT) submission by Mesoblast to the FDA for Revascor in 2017.
A 76 percent reduction in GI bleeding events was observed in the recent 159-patient trial (p<0.001).
This was further associated with a 65 percent reduction in hospitalizations due to GI bleeding (p<0.001).
The company plans to meet with the FDA in the upcoming quarter to discuss an approval pathway for Revascor under its existing RMAT designation, which provides eligibility for priority review and accelerated approval.
Mesoblast has received guidance from the FDA that reduction in GI bleeding and associated hospitalizations are a clinically meaningful outcome that can support marketing approval.
The company will present the concordant results from the prior two trials, together with the plan for a confirmatory trial powered for the primary endpoint of reduction in GI bleeding.
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|Publication:||Stem Cell Research News|
|Date:||Apr 22, 2019|
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