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Mesoblast Limited, (ASX: MSB) received clearance to begin a 225-patient multi-center P2 clinical trial.

ASX: MSB received clearance from the European Medicines Agency (NYSEMKT:EMA) to begin a 225-patient multi-center P2 clinical trial in the EU for its lead cardiovascular product Revascor(NYSE:TM) in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack.

 

Revascor(TM) is an allogeneic, or “off-the-shelf”, adult stem cell product derived from MSBs proprietary Mesenchymal Precursor Cell (NYSE:MPC) platform technology which is being developed for use in a range of cardiovascular diseases including congestive heart failure, chronic angina, and heart attacks (acute myocardial infarction). Revascor(TM) is injected by a simple intracoronary infusion at the same time as the angioplasty and stent procedure, within 12 hours of the heart attack. In preclinical trials, a simple intracoronary infusion of MSBs off-the-shelf MPCs increased the number of blood vessels in the infarcted region, prevented scar formation, and significantly improved heart muscle function after a heart attack, preventing heart failure.

  • The placebo-controlled P2 trial, AMICI (Allogeneic Mesenchymal precursor cell Infusion in myocardial Infarction), is approved under EU’s voluntary harmonization procedure and will initially recruit patients at multiple EU sites, including in the UK,
  • Trial recruitment is subsequently expected to involve sites in additional EU nations, Australia and theUS.  .

The Bottom Line: The preclinical data were very compelling, and formed the basis for this clinical trial. RENE offers a minimally invasive clinical approach. This stem cell product might have the potential to change the medical paradigm for treatment of large heart attacks, and to provide for the 1st time a validated and effective off-the-shelf therapy for routine use. MSB is progressing into a 2nd major clinical indication for its proprietary stem cell product Revascor(TM), which is already well advanced in clinical development for congestive heart failure, with plans to expand its use for chronic refractory angina.The primary endpoint of the study will be safety and efficacy at 6 months in heart attack patients who will receive either Revascor(TM) at 1 of 2 doses or placebo. Durability of effect will additionally be monitored for up to 36 months