MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHED BY THE U.S. NATIONAL INSTITUTES OF HEALTH’S NATIONAL HEART, LUNG AND BLOOD INSTITUTE TO CONDUCT RANDOMIZED CONTROLLED TRIAL OF REMESTEMCEL-L FOR PATIENTS WITH ACUTE RESPIRATORY

NEW YORK, April 08, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.

Mesoblast Chief Executive Dr Silviu Itescu stated: “This significant public-private partnership is a prime example of how the combined resources of industry and government can be leveraged to evaluate in a most efficient and rigorous manner the potential of innovative therapies to make a meaningful difference to patient outcomes.”

CTSN Chairman Dr A. Marc Gillinov said: “We are excited to work with Mesoblast to make a real impact on the high mortality associated with COVID-19. This randomized controlled trial is in line with our mandate to rigorously evaluate novel therapies for public health imperatives.”

Professor and System Chair of Population Health Science and Policy and the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, Dr Annetine Gelijns, said: “The COVID-19 pandemic has resulted in very large numbers of people suffering with ARDS requiring ventilation in hospital intensive care units, with dismal outcomes, placing an enormous burden on the United States health system. We are committed to evaluating whether Mesoblast’s mesenchymal stem cell product candidate for ARDS has the potential to make an impact on this unprecedented health crisis.”