Stem Cell Advisor

Melbourne, Australia; May 31 and New York, USA; May 30, 2022: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on survival outcomes from the randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) and plans for a pivotal trial with collaborative investigators.  Through the initial 90 days, remestemcel-L reduced mortality by 48% compared to controls in a prespecified analysis of 123 patients below age 65 (26% vs 44%, p=0.038),(1,2) but not in 97 patients over age 65, as previously reported. In an exploratory analysis in patients under age 65 who also received dexamethasone as part of their standard of care, remestemcel-L reduced 90-day mortality by 77% compared to controls (14% vs 48%, p=0.0037).1,2 These early survival outcomes in the remestemcelL group relative to controls were maintained at later...

Basel,  November   19 , 20 20  — Novartis announced that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19 . ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which includes prolonged ICU treatment and mechanical ventilation. 1 ,2  As the potential first ARDS therapy, remestemcel-L will use mesenchymal stromal cells (MSCs), a cell-based platform technology, to treat this deadly condition and improve outcomes. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing 300-patient Phase III study. 3  Novartis intends to initiate a Phase III study in non-COVID-19-related ARDS after the anticipated closing of the license agreement and successful completion and outcome of the current st...