High survival rates in trial against severe COVID-19—related respiratory distress

Written by Alexander Marshall

Patients with severe COVID-19—related acute respiratory distress demonstrated an 83% survival rate following stem cell therapy.

Compassionate use of a cell therapy product developed by clinical-stage cell therapy company Mesoblast (Melbourne, Australia) suggests that ventilator-dependent patients with COVID-19 had their survival rate increased to 83% from 12% following treatment with mesenchymal stem cells (MSCs). The patients had all developed moderate or severe acute respiratory distress syndrome (ARDS), which currently can only be managed with ventilator support and is often fatal.

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Patients were treated over a period of 2 months at Mount Sinai Hospital (NY, USA). Two intravenous infusions of Ryoncilâ„¢, an allogeneic MSC product from Mesoblast that also goes by the name remestemcel-L, were administered to 12 patients under an emergency Investigational New Drug (IND) application or expanded access protocol. The treatment took 5 days and resulted in 83% of patients surviving. 75% of treated patients were also able to come off ventilator support. This is in stark contrast to the 12% survival rate and 9% of patients who were able to come off ventilators amongst untreated patients.

“There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase II/III trial as recommended by the US Food and Drug Administration (FDA; MD, USA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate and severe COVID-19 ARDS,” explained Fred Grossman, Chief Medical Officer of Mesoblast.

ARDS is the predominant cause of death following COVID-19 infection and is also associated with infections such as pneumonia. The persistent infection leads to an inappropriate immune response, which damages the lung tissue of the patient. The cell therapy community has been investigating how best to utilize the immunomodulatory qualities of MSCs to dampen this aggressive immune response.

“The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase II/III trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients,” commented Silviu Itescu, Chief Executive of Mesoblast.

The company hopes to quickly complete a Phase II/III clinical trial and release their product for the treatment of COVID-19—related ARDS.

Source: http://investorsmedia.mesoblast.com/static-files/337e723a-340d-493e-a4a1-0971d2c71460

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