Phase III interim success for MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF).-Mesoblast
Mesoblast Limited announced that the Phase III trial of its allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF) was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial's first 270 patients. It is expected that the trial will enroll in total approximately 600 patients.
After notifying the Company of the interim analysis results, the trial�s Independent Data Monitoring Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned. This ongoing double-blinded randomized (1:1) trial is currently being conducted across multiple study sites in the United States and Canada. It is evaluating MPC-150-IM in adult patients with moderate to advanced New York Heart Association (NYHA) Class II/III chronic heart failure with left ventricular systolic dysfunction. The trial�s primary efficacy endpoint is a comparison of recurrent non-fatal heart failure-related major adverse cardiac events (HF-MACE) in moderate to advanced CHF patients receiving either MPC-150-IM by catheter injection into the damaged left ventricular heart muscle or sham control. A Joint Frailty Model is the statistical method that evaluates multiple non-fatal heart failure-related events per patient (such as repeated hospitalizations for decompensated heart failure) while accounting for increased likelihood of a terminal cardiac event (such as death, implantation of a mechanical heart assist device or a heart transplant) for patients with multiple non-fatal heart failure events.
In line with best practice for blinded Phase III clinical trials, the interim analysis data are only reviewed by the IDMC. Mesoblast, the FDA, and trial investigators are blinded to grouped safety and efficacy data for the ongoing trial as well as the numerical results of this interim analysis.
Teva returned rights to MPC-150-IM in June 2016.
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