CytoSorbents Corporation (CTSO)

[techxen]

FDA clears Mesoblast Remestemcel for cytokines/ARDS

From this press release yesterday it sounds like the FDA has approved an application for Covid-19 for treatment of ARDS and elevated cytokines. I was not familiar with Mesoblast or this drug, nor is it referenced in the Cytosorbents 10k from 2019 or from any of the historical conference call transcripts. Apparently it has been used in over 1,100 patients in various trials to date and the FDA has approved it not only for expanded access compassionate use but also in a planned randomized control trial.

Any one with a medical background or knowledge of this drug care to comment? I might be missing something but it appears to address some of the same conditions in which Cytosorb could be used.

FDA CLEARS INVESTIGATIONAL NEW DRUG APPLICATION FOR MESOBLAST TO USE REMESTEMCEL-L IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME CAUSED BY COVID-19
https://finance.yahoo.com/news/fda-clears-investigational-drug-application-100010964.html

NEW YORK, April 06, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has received clearance from the United States Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to treat patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19) with intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L.

Mesoblast Chief Medical Officer Dr Fred Grossman said: “The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial.”

Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.

Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS. Additionally, a post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS. Together, these outcomes provide the rationale for evaluating remestemcel-L in patients with COVID-19 ARDS.