CytoSorbents Announces the Data Safety Monitoring Board Recommends Continuation of REMOVE Endocarditis Trial
MONMOUTH JUNCTION, NJ – February 5, 2019 - CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the Data Safety Monitoring Board (DSMB) of the German government-funded REMOVE Endocarditis trial recommended continuation of the study following an interim analysis on the first 50 patients of the study.
Prof. Dr. med. Frank Brunkhorst, Director of the Center for Clinical Studies at Jena University Hospital who is providing management and oversight to the REMOVE trial, and Prof. Dr. med. Torsten Doenst, Director of the Clinic for Cardiac and Thoracic Surgery at the University of Jena, provided a joint statement, “The Scientific Advisory Board (SAB) of the Center of Sepsis Control and Care (CSCC) and the Data Safety Monitoring Board (DSMB) of the REMOVE study recommended continuation of the study, based upon results of a pre-specified interim analysis that analyzed cytokine and vasoactive mediator levels as an indicator of the mechanistic mode of action of the device in 28 CytoSorb-treated patients and 22 control patients. There were no device-associated adverse events in the CytoSorb group.”
Dr. med. Mahmoud Diab, Principal Investigator of the REMOVE Trial, senior cardiac surgeon and Head of the Endocarditis division at the Clinic for Cardiac and Thoracic Surgery at the University of Jena stated, "We are pleased to have passed this significant milestone for the REMOVE endocarditis trial and thank all of the participating centers for their continued contributions to this important study. We are eager to continue the trial so that we will get important information on the clinical end points in these critically-ill patients. We thank the German government for support. Currently, enrollment is in-line with our goals, and we are confident in being able to advance this trial to completion."
The REMOVE Trial (“REvealing Mechanisms and Investigating Efficacy Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis”) is a 250 patient randomized controlled, multi-center clinical trial in Germany designed to evaluate the safety and efficacy of intraoperative CytoSorb use during valve replacement surgery and cardiopulmonary bypass in patients with a dangerous bacterial heart valve infection. Trial collaborators include CytoSorbents, B.R.A.H.M.S. (a division of Thermo Fisher Scientific), and the Fraunhofer Institute for Interfacial Engineering and Biotechnology. The REMOVE trial is currently enrolling patients with documented infective endocarditis (according to DUKE criteria), with a EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) > 3, and who require open heart surgery. The goal of the study is to demonstrate improved hemodynamic stability and reduced organ injury as primarily measured by the change in the Sequential Organ Failure Assessment (SOFA) Score with secondary endpoints measuring 30-day mortality, the need for supportive care therapies such as vasopressors, mechanical ventilation, and dialysis, incidence of stroke, and the length of intensive care unit and in-hospital stay.