CytoSorbents Corporation (CTSO)

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CytoSorbents’ Pivotal STAR-T Trial Reaches Second Key Milestone With 80 Patients Enrolled

CytoSorbents
Thu, April 20, 2023 at 7:00 AM EDT

PRINCETON, N.J., April 20, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces that its pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial has enrolled 80 patients, achieving the second of three key enrollment milestones, and triggering a pre-specified Data and Safety Monitoring Board (DSMB) safety review.

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are pleased with the solid enrollment pace of the STAR-T trial, now two-thirds enrolled, and believe it reflects a) the positive enthusiasm and commitment of participating U.S. and Canadian study centers, b) the large unmet medical need and numbers of patients on ticagrelor undergoing cardiothoracic surgery, and c) the laser focus of our clinical team. We expect completion of the second DSMB safety review over the next several months.”

Dr. Deliargyris continued, “Because of the brisk enrollment of the trial, we continue to project that STAR-T will be fully enrolled this summer. Because of this, as we discussed in our last earnings call in March, we have elected to forego an interim analysis at this stage which would have otherwise taken several months to conclude, and instead race to complete trial enrollment on schedule and initiate the final study analysis, while preserving the full statistical power of the study. This would put us in the position of having top-line data later this year, with the goal of filing for U.S. FDA and Health Canada regulatory approval thereafter.”

The STAR-T trial intends to enroll approximately 120 patients at 30 centers in the U.S. and Canada to evaluate whether intraoperative use of DrugSorb®-ATR can reduce the high perioperative risk of bleeding in patients undergoing cardiothoracic surgery who have recently received the blood thinning agent, ticagrelor. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application, for which CytoSorbents received FDA Breakthrough Device Designation in April 2020, recognizing it as a major unmet medical need for which there are no FDA-approved or cleared therapies.

https://finance.yahoo.com/news/cytosorbents-pivotal-star-t-trial-110000273.html