CytoSorbents Completes Enrollment of the STAR-T Pivotal Trial
PRINCETON, N.J., July 07, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed enrollment of the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) randomized, controlled trial, evaluating the ability of DrugSorb®-ATR to reduce perioperative bleeding in patients undergoing cardiothoracic surgery on ticagrelor.
The STAR-T trial Principal Investigators, Drs. Michael Mack, C. Michael Gibson, and Richard Whitlock, commented in a joint statement, “We want to thank all participating investigators and their research teams for their commitment and dedication that helped STAR-T complete enrollment ahead of projections. Ticagrelor (Brilinta®, AstraZeneca) is used widely in the U.S. and Canada and we routinely encounter patients on ticagrelor who require cardiothoracic surgery. Currently, because of the high risk of bleeding complications in these patients, we delay surgery for multiple days until the ticagrelor effect is worn off which carries the risk that these patients suffer a complication while waiting, but also significantly increases the length and cost of their hospitalization. The surgical community is in urgent need of a solution that allows the safe and timely treatment of these high-risk patients. We look forward to the results of STAR-T which we plan to present at a major international cardiovascular conference in early 2024 and remain committed to lead further trials investigating drug removal by DrugSorb-ATR of additional antithrombotic agents, such as the direct oral anticoagulants apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) that are among the most widely prescribed medications in the world.”
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are very pleased to deliver STAR-T across the finish line ahead of schedule. The fast enrollment pace was the direct result of the high frequency that eligible patients presented at our participating sites validating the large size of the unmet need. With this major milestone achieved, our attention now turns to completion of data collection and study closeout activities ahead of the final results. With our clinical operations capabilities now fully in place we look forward to executing the next round of trials, including STAR-D, investigating the expansion of antithrombotic drug removal to additional agents and hospital wide applications beyond cardiac surgery.”
The STAR-T randomized, controlled trial is a pivotal study being conducted in both the U.S. and Canada that is designed to evaluate the ability of DrugSorb-ATR® to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q1 2023, more than 203,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA and Health Canada-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately
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CytoSorbents Contact:
Kathleen Bloch
Interim Chief Financial Officer
(732) 398-5429
kbloch@cytosorbents.com
