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Global leader in allogeneic cellular medicines for inflammatory diseases Mesoblast has announced that the Phase III (DREAM-HF) trial of its mesenchymal precursor cell therapy (MPCs: rexlemestrocel-L) strengthened heart function in patients with chronic heart failure (CHF).
Data from Mesoblast’s DREAM-HF Phase III trial – a randomized, double-blind, controlled study of 537 patients with CHF caused by reduced ejection fraction (HFrEF) – has been presented in The Journal of the American College of Cardiology (JACC), a premier peer-reviewed journal for cardiovascular medicine.
The patient population enrolled across 51 sites in North America, received a single intra-myocardial injection of 150 million cells of rexlemestrocel-L. Results at a mean follow-up of 30 months demonstrated that:
- Left ventricular ejection fraction (LVEF) improved over 12 months to a significantly greater extent than controls.
- All patients had a reduced risk of myocardial infarction (MI) or stroke of 57%. This increased to 75% in patients with inflammation.
- The time-to-first major adverse cardiac event (MACE), which included cardiovascular death, MI, or stroke, was reduced by 28% in all patients. Again this increased to 37% in patients with inflammation.
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“We are very encouraged by these study data that indicate the potential of our allogeneic cellular therapy to address the major areas of unmet need in heart failure patients where conventional treatments are not effective. Improvement in LVEF at 12 months may be a functional surrogate endpoint for rexlemestrocel-L’s subsequent benefits on long-term MACE outcomes and survival in this high-risk patient population with chronic heart failure,” commented Dr. Silviu Itescu, Mesoblast, CEO.
MPC therapy appears to act as an immune modulator, reducing inflammation both locally in the cardiac muscle, and throughout the blood vessels of the body.
When activated rexlemestrocel-L strengthens cardiac muscle, protecting it from death, increasing microvascular blood flow, and improving cardiac energetics. In the large blood vessels outside the heart, they potentially decrease plaque instability.
Following the publication of its positive DREAM-HF results, Mesoblast released plans to meet with the FDA in Q2 2023 to discuss the potential pathway to achieve marketing approval in HFrEF for this previously RMAT-designated allogeneic cell therapy.
“MPC therapy could change the future of cardiovascular care for patients with heart failure due to inflammation,” notes Dr. Joseph G. Rogers, CEO and President of The Texas Heart Institute.
Source: Mesoblast asx announcement
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