Revascor Enhances Survival and Lowers Major Morbidity in High-Risk Inflammatory Ischemic Heart Failure Patients

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has announced significant findings published in the November 2024 issue of the European Journal of Heart Failure (EJHF). The study reports that a single intramyocardial injection of Mesoblast’s allogeneic cell therapy, Revascor® (rexlemestrocel-L), improves survival rates in high-risk patients suffering from ischemic heart failure and inflammation.

The DREAM-HF trial, a randomized, controlled study, focused on patients with chronic heart failure characterized by reduced ejection fraction (HFrEF). The trial pinpointed the control group at highest risk of cardiovascular death as those with ischemic etiology and inflammation. It demonstrated that a single intramyocardial injection of Mesoblast’s mesenchymal precursor cell therapy (MPCs; rexlemestrocel-L) significantly reduced cardiovascular mortality in this high-risk group. This insight identifies the target population with HFrEF that benefits from Revascor therapy.

Dr. Emerson C. Perin, the lead investigator and Medical Director at The Texas Heart Institute, commented on the findings, stating that Mesoblast’s allogeneic MPCs might restore the balance between anti-inflammatory and pro-inflammatory cytokines in damaged, inflamed hearts. He noted that a single administration of MPCs improved survival and other major clinical outcomes in high-risk HFrEF patients with inflammation. These benefits were seen on top of existing treatments, offering a disease-modifying approach beyond the capabilities of standard care.

The trial's newly published results over a mean follow-up period of 30 months revealed that inflammation (measured by baseline plasma high-sensitivity C-reactive protein) and ischemic HFrEF etiology posed the greatest risks for cardiovascular death in control patients. The risk increased by 61% with inflammation and 38% with ischemic etiology. A single intramyocardial MPC administration significantly lowered cardiovascular death risk by 80% and 60%, respectively, regardless of whether plasma hsCRP or plasma IL-6 was used as the inflammatory biomarker.

Further analysis showed that MPCs reduced the incidence of major adverse cardiovascular events (MACE). Specifically, the therapy lowered the risk of two-point MACE (heart attack or stroke) by 57% and three-point MACE (cardiovascular death, heart attack, stroke) by 35% in patients with ischemic HFrEF. For those with both ischemic HFrEF and inflammation, the reductions were even more striking: 88% for two-point MACE and 52% for three-point MACE.

Mesoblast’s Chief Executive Dr. Silviu Itescu highlighted the broader implications of these results for the ischemic HFrEF population, noting the potential for REVASCOR to offer significant mortality benefits. He also mentioned that the company had received feedback from the U.S. Food and Drug Administration (FDA) supporting an accelerated approval pathway for REVASCOR in end-stage ischemic HFrEF patients with a left ventricular assist device (LVAD).

Revascor® (rexlemestrocel-L) is an allogeneic preparation of immunoselected and culture-expanded mesenchymal precursor cells (MPC), developed as an immunomodulatory therapy to address high inflammation levels in the heart and cardiovascular system present in HFrEF patients. It has undergone evaluation in two large placebo-controlled randomized studies, including the 537-patient DREAM-HF trial and a 159-patient trial involving end-stage HFrEF patients with LVADs.

Rexlemestrocel-L holds FDA Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for end-stage HFrEF patients with LVADs.

Chronic heart failure (CHF) affects approximately 6.5 million individuals in the United States and 26 million globally. The condition is marked by poor heart function, leading to insufficient blood flow to vital organs. Patients are classified into New York Heart Association (NYHA) categories based on physical limitations, with higher classes indicating more severe disease. Despite new therapies, patients with NYHA class II/III HFrEF and inflammation remain at high risk for cardiovascular events.

Mesoblast is a leading developer of allogeneic cellular medicines for severe inflammatory conditions, leveraging its mesenchymal lineage cell therapy technology to create a broad portfolio of products. The company operates globally, with locations in Australia, the United States, and Singapore, and is publicly listed on the Australian Securities Exchange and Nasdaq.

For more details on Mesoblast's therapies and ongoing research, visit their website or follow their social media channels.