- Mesoblast (MSB) reports results from a recent phase III trial showing increased heart function in patients treated with its rexlemestrocel-L product
- The results show reduced cardiovascular death, myocardial infarction and stroke over a 30-month follow-up period, strengthening heart function in just 12 months
- The study was a randomised, double-blind, controlled study of 537 patients in North America
- Mesoblast has published its DREAM-HF trial results in the Journal of the American College of Cardiology
- Mesoblast shares last traded at 93 cents on Monday afternoon
Mesoblast (MSB) has reported results from a recent phase III trial showing increased heart function in patients treated with its rexlemestrocel-L product.
The results indicated Mesoblast’s mesenchymal precursor cell (MPC) therapy strengthened heart function and decreased cardiovascular death or stroke in patients with chronic heart failure.
In the randomised, double-blind, controlled study of 537 patients, the drug was shown to increase heart function at 12 months and decrease heart failure over a mean follow-up period of 30 months.
The study enrolled patients across 51 sites in North America, and the results of a one-time intra-myocardial injection of 150 million cells of rexlemestrocel-L show a reduced risk of myocardial infarction or stroke and reduced risk for a time-to-first major adverse cardiac event.
Mesobast CEO Silviu Itescu said the study results indicated the potential of the company’s cellular therapy to address “major areas of unmet need” in heart failure patients.
“Improvement in left ventricular ejection fraction 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,” Dr Itescu said.
The company published the results of its DREAM-HF phase III trial in the peer-reviewed journal for cardiovascular medicine, Journal of the American College of Cardiology (JACC).
Mesoblast intends to meet with the US Food & Drug Administration in the next quarter to find a potential pathway to marketing approval.
Mesoblast shares last traded at 93 cents on Monday afternoon.