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.