Business
CytoSorbents Announces the REFRESH 2-AKI Trial Data Monitoring Committee Has Recommended Study Resumption Following Favorable Review of Safety Data
MONMOUTH JUNCTION, N.J., July 28, 2020 /PRNewswire/ -- CytoSorbents Corporation (Nasdaq: CTSO), a critical care immunotherapy leader commercializing its
About this update from Cytosorbents Corporation
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., July 28, 2020 /PRNewswire/ -- CytoSorbents Corporation (Nasdaq: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the Data Monitoring Committee (DMC) of the REFRESH 2-AKI trial has completed a comprehensive favorable review of safety data from the study with a positive recommendation to resume the trial.\n\n \n \n \n \n \n \n\n \nAs previously discussed, on November 25, 2019, the Company announced a change in its contract research organization (CRO) for the REFRESH 2-AKI trial and voluntarily paused enrollment of the study. This was in response to a blinded, interim review of clinical study data by the Data Monitoring Committee (DMC) that requested additional clinical data and data analyses, not pre-specified in the trial protocol, to improve patient safety endpoint monitoring. Since then, the Company and its new CRO have completed a comprehensive program to re-monitor existing data, collect new data, and analyze the safety data from the 153 patients included in the trial to date. These data were reviewed by the DMC last week resulting in a favorable opinion on safety, dated 7/24/20, and the recommendation to resume the trial with only minor modifications.\nMr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, \"Since November, in close collaboration with our new CRO, we aggressively and successfully re-monitored existing data and acquired new data requested by the DMC at all REFRESH 2 sites. We remained on schedule despite a challenging COVID-19 environment and the closure of many clinical trial centers. We recently concluded the safety analysis and presentation to the DMC, and are pleased with their recommendation to continue the trial.\"\nDr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, \"The completion of the first milestone safety review by the DMC and their recommendation to resume the trial is a major achievement for the REFRESH-2 study. The safety profile of CytoSorb in real world practice has been favorable in over 98,000 treatments, including approximately a third related to cardiac surgery. The unremarkable findings of the interim DMC safety review of the REFRESH...