CytoSorbents Receives Recommendation from Independent Data and Safety Monitoring Board to Continue Pivotal STAR-T Trial As Planned Without Modifications

Rhea-AI Summary

CytoSorbents Corporation (NASDAQ: CTSO) has received a recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue its pivotal STAR-T trial without modifications. The trial evaluates DrugSorb-ATR's ability to reduce perioperative bleeding by removing the antithrombotic drug ticagrelor during cardiothoracic surgery. The trial aims to enroll 120 patients across 30 centers and is critical for FDA and Health Canada marketing approval. The company aims to enroll 80 patients by Spring 2023, marking a significant milestone in the study.

Positive

• DSMB recommends continuation of STAR-T trial without modifications.
• First milestone achieved with 40 patients enrolled.
• Potential for FDA and Health Canada marketing approval for DrugSorb-ATR.

Negative

• None.

PRINCETON, N.J., Dec. 21, 2022 /PRNewswire/ -- 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, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications.  

Independent DSMB reviews unblinded data and recommends STAR-T study continue unchanged after first enrollment milestone

 Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, "The independent DSMB has completed the review of the full unblinded dataset from the first 40 patients enrolled in the STAR-T trial and we are very pleased to receive the recommendation to continue the study as planned without any modifications.  All our clinical resources continue to focus on enrollment with the goal of achieving the next milestone of 80 patients enrolled by Spring 2023, triggering another safety review and the execution of the trial's prespecified interim analysis by the independent DSMB."

The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study 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 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery,                                                 the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose.   Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery.  DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication.  The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application. 

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 inflammatory mediators that can lead to postoperative complications, including multiple organ failure.  As of September 30, 2022, more than 186,000 CytoSorb devices have 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-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers 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 FDA marketing approval in the United States 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 $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K⁺ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others.  For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter. 

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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CytoSorbents Contact: 
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com

 

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SOURCE CytoSorbents Corporation

FAQ

What did CytoSorbents announce on December 21, 2022?

On December 21, 2022, CytoSorbents announced the recommendation from the DSMB to continue the STAR-T trial as planned.

What is the STAR-T trial evaluating?

The STAR-T trial evaluates DrugSorb-ATR's effectiveness in reducing perioperative bleeding during cardiothoracic surgery by removing ticagrelor.

What is the significance of the DSMB's recommendation for CTSO stockholders?

The DSMB's recommendation indicates positive progress in their pivotal trial, which is essential for potential FDA approval, impacting stockholder confidence.

How many patients are targeted in the STAR-T trial?

The STAR-T trial aims to enroll a total of 120 patients.

What milestone is CytoSorbents aiming to achieve by Spring 2023?

CytoSorbents aims to enroll 80 patients by Spring 2023 for the next safety review.