Tuesday, July 28, 2020
CytoSorbents Corporation, a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the Data Monitoring Committee (DMC) of the REFRESH 2-AKI trial has completed a comprehensive favorable review of safety data from the study with a positive recommendation to resume the trial.
As previously discussed, on November 25, 2019, the Company announced a change in its contract research organization (CRO) for the REFRESH 2-AKI trial and voluntarily paused enrollment of the study. This was in response to a blinded, interim review of clinical study data by the Data Monitoring Committee (DMC) that requested additional clinical data and data analyses, not pre-specified in the trial protocol, to improve patient safety endpoint monitoring. Since then, the Company and its new CRO have completed a comprehensive program to re-monitor existing data, collect new data, and analyze the safety data from the 153 patients included in the trial to date. These data were reviewed by the DMC last week resulting in a favorable opinion on safety, dated 7/24/20, and the recommendation to resume the trial with only minor modifications.
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "Since November, in close collaboration with our new CRO, we aggressively and successfully re-monitored existing data and acquired new data requested by the DMC at all REFRESH 2 sites. We remained on schedule despite a challenging COVID-19 environment and the closure of many clinical trial centers. We recently concluded the safety analysis and presentation to the DMC, and are pleased with their recommendation to continue the trial."
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, "The completion of the first milestone safety review by the DMC and their recommendation to resume the trial is a major achievement for the REFRESH-2 study. The safety profile of CytoSorb in real world practice has been favorable in over 98,000 treatments, including approximately a third related to cardiac surgery. The unremarkable findings of the interim DMC safety review of the REFRESH 2-AKI trial data are consistent with this observation, even when using the dual CytoSorb devices employed in the study. With the upcoming results from the REMOVE trial evaluating the intraoperative use of CytoSorb in high risk heart valve replacement surgery for infective endocarditis, the recent E.U. approvals for ticagrelor and rivaroxaban removal during cardiac surgery, and the U.S. FDA Breakthrough Designation for ticagrelor removal during cardiopulmonary bypass, the use of CytoSorb in cardiac surgery represents an incredibly exciting area of potential growth that we plan to pursue aggressively."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 65 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 98,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted U.S. FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
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 more than $37 million from DARPA, the Defense Health Agency, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC), the U.S. Department of Health and Human Services, and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, 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.
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, 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, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. 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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