DREAM-HF trial sheds positive light on Revascor for ischemic HF

Mesoblast Limited recently announced positive Phase III trial results in the European Journal of Heart Failure. The use of Revascor improved survival and reduced major morbidity in high-risk patients with ischemic heart failure (HF) and inflammation. Currently, the majority of marketed and pipeline drugs simply slow the progression of the disease, reduce mortality, and reduce HF hospitalisations. The ideal therapy must demonstrate regenerative potential, repairing cardiac damage and reversing disease progression. However, regenerative therapies come with high price tags and may struggle to gain market share against substantially cheaper, generic drugs. Leading data and analytics company GlobalData believes that this study could be of high clinical value to cardiologists who are seeking an optimal treatment of choice for HF patients.
Revascor is an allogeneic mesenchymal precursor cell therapy product that is delivered to damaged areas of the heart by a minimally invasive cardiac catheterisation procedure performed under local anaesthesia while the patient is awake. Results from the DREAM-HF trial showed that Revascor reduced cardiovascular mortality and major adverse cardiovascular events, and improved left ventricular function in high-risk HF patients. Over a mean follow-up of 30 months in the study, a single intramyocardial injection of Revascor resulted in a sustained reduction in cardiovascular mortality in high-risk HF patients. Additionally, a single intramyocardial injection significantly lowered the risk of cardiovascular death in HF patients with reduced ejection fraction with inflammation. The treatment also demonstrated a reduction in the risk of heart attacks, strokes, and recurrent hospitalisations. Key opinion leaders interviewed by GlobalData emphasised that mesenchymal cells are very promising and the use of cells for the regeneration of the myocardium, to reverse the cardiac remodelling, is very promising for the long term, and offers a new treatment approach.
Mesoblast is a regenerative medicine company that develops regenerative cell-based products. Mesoblast is headquartered in Melbourne, Victoria, Australia. In July 2018, Mesoblast completed a transaction with Tasly Pharmaceutical Group for the development, manufacture, and commercialisation in China of Mesoblast’s allogeneic mesenchymal precursor cell products: Revascor for chronic HF and MPC-25-IC for acute myocardial infarction. Both companies plan to leverage each other’s clinical trial results to support regulatory submissions. The US Food and Drug Administration granted regenerative medicine advanced therapy and orphan drug designations to Revascor for left ventricular dysfunction.