CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial



CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis.

The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said.

The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays.

“We are very grateful to the German government for their commitment to fund the Remove trial in its entirety, and to Prof. Dr. med. Frank Brunkhorst, the Center for Clinical Studies Jena, and Jena University Hospital for sponsoring the study.  Infective endocarditis, or infection of a heart valve, can destroy the valve in hours to days, and can rapidly lead to emergency open heart valve replacement surgery in very sick patients that suffer from both sepsis and heart failure.  Patients are often unstable before, during, and after the surgery, and are prone to a high risk of complications and death, as well as a costly and lengthy hospital stay.  This is a rapidly growing problem, driven by the aging population and the opioid crisis, where the use of dirty needles by intravenous drug abusers can lead to seeding of bacteria in the bloodstream and heart valve infection,” CEO Dr. Phillip Chan said in a prepared statement.

CytoSorbents expects the trial to begin early next year, in collaboration with Thermo Fisher Scientific’s B.R.A.H.M.S and the Fraunhofer Institute for Interfacial Engineering and Biotechnology.

“This announcement of funding and collaboration follows our previous press release on October 19, 2017 highlighting the largest published endocarditis case series to date, where the intraoperative use of CytoSorb during emergent and urgent valve replacement surgery helped to improve hemodynamic stability, reduce the need for vasopressors, and was associated with a reduction of in-hospital mortality compared to a historical control.  We believe that similar results could be seen in the Remove trial.  Interestingly, the Remove study will parallel our Refresh 2 pivotal, registration trial in the U.S., designed to support FDA regulatory approval.  The Refresh 2 trial will also focus on the intraoperative use of CytoSorb during valve replacement surgery – but specifically excludes infective endocarditis – to reduce the incidence or severity of post-operative organ dysfunction. If successful, the two trials could rapidly lead to the use of CytoSorb as standard of care in most, if not all, open heart valve replacement surgeries, which accounts for hundreds of thousands of procedures worldwide,” CEO Dr. Chan said in a press release.

In May, CytoSorbents presented results from the Refresh trial of its CytoSorb blood purification tech, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

CytoSorbents touts Refresh trial study data

CytosorbentsCytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.

The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.

The prospective, randomized trial looked to evaluate the safety and feasibility of the CytoSorb in treating deadly inflammation in critically-ill and cardiac surgery patients between 18 and 80 years.

Results from the study indicate that valve replacement surgery was the highest risk procedure for peak plasma free hemoglobin, and that treatment with the CytoSorb increased reductions in peak pfHb levels by 26% at 3.5 hours and 38% at 4 hours. Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery, according to CytoSorbents

The company said that the trial achieved its primary safety endpoint with a favorable adjudication of all serious adverse events, and no significant differences in the rate of adverse events or serious adverse events at 30 days. No unanticipated adverse device effects were reported.

“We are pleased to report on this first multi-center U.S. trial demonstrating the safe and easily implemented use of CytoSorb during high risk complex cardiac surgery.  Inflammation and toxic injury from excessive plasma free hemoglobin and activated complement are well-known insults that are associated with organ injury such as acute kidney injury, stroke, lung injury, and other complications.  The finding that complex valve replacement procedures generate high levels of pfHb, and that CytoSorb can significantly reduce pfHb and activated complement in this population, represents a potentially important advance in the field.  In a future larger study, we plan to correlate the reduction of pfHb and activated complement in this enriched at-risk population with reduced organ dysfunction and injury, while confirming the risk/benefit of the therapy,” principal investigator Dr. Joseph Zwischenberge of the University of Kentucky College of Medicine said in a press release.

In January, CytoSorbents and  Fresenius Medical Care (NYSE:FMS) said that they expanded the terms of their partnership and added a co-marketing agreement for the CytoSorb blood absorber in countries where the therapy is available.