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CytoSorb Used Successfully to Help Treat Grade 4 Cytokine Release Syndrome Following CAR T-cell Immunotherapy in First Published Case Report

February 5, 2020 GMT
CytoSorbents Logo. (PRNewsFoto/CytoSorbents)
CytoSorbents Logo. (PRNewsFoto/CytoSorbents)

MONMOUTH JUNCTION, N.J., Feb. 5, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the first published case report detailing the successful use of CytoSorb to help treat cytokine release syndrome (CRS) following the administration of CAR T-cell immunotherapy. In a recent publication entitled, ” Multimodal Therapeutic Approach of Cytokine Release Syndrome Developing in a Child Given Chimeric Antigen Receptor-Modified T Cell Infusion ”, in the journal, Critical Care Explorations, a publication of the Society of Critical Care Medicine, Bottari and colleagues highlight the use of CytoSorb, in conjunction with continuous renal replacement and tocilizumab, to help treat a 14-year old boy with refractory acute lymphoblastic leukemia (ALL), who developed Grade 4 cytokine release syndrome (CRS) with progressive respiratory failure and severe acute respiratory distress syndrome (ARDS) following the administration of CAR T-cell immunotherapy.

Dr. Joerg Scheier, Senior European Medical Director of CytoSorbents stated, “We are pleased to report the first published use of CytoSorb to assist in the rescue of a patient suffering from life-threatening cytokine release syndrome due to CAR T-cell immunotherapy. The combination of CytoSorb with continuous renal replacement therapy, and tocilizumab, was simple and safe to implement. More importantly, it led to a dramatic reversal of acute respiratory distress syndrome, one of the most deadly forms of lung injury that is a root cause of death in the Wuhan coronavirus outbreak, with a corresponding profound drop in cytokine storm and circulating inflammatory mediators. We believe this successful proof-of-concept treatment supports the consideration of this treatment regimen in future cases of CRS triggered by CAR T-cell immunotherapy.”

This patient had previously failed treatment of his ALL with both chemotherapy and immunotherapy, and was enrolled into an academic CAR T-cell immunotherapy trial. However, 7 days after the CAR T-cell therapy infusion, he developed severe cytokine release syndrome (a form of cytokine storm), and the rapid progression of respiratory failure that did not respond to an initial dose of tocilizumab and low dose steroids. The patient was admitted to the pediatric intensive care unit (PICU) and placed on mechanical ventilation for profound ARDS with a PaO2/FiO2 (P/F) ratio of 45 mm Hg, and hemodynamic instability requiring vasopressors. His Grade 4 cytokine release syndrome (CRS) exhibited extremely high cytokine and inflammatory marker levels, including an IL-6 of 4,048 pg/mL and a ferritin of 146,095 ng/mL. The patient underwent five blood purification treatments with CytoSorb, changed every 12 hours for the first day, and then every 24 hours for the next 3 days, in conjunction with continuous renal replacement therapy (CRRT), with tocilizumab administered on the last 2 days of CytoSorb treatment. In the first 3 days of CytoSorb treatment, the ferritin levels dramatically decreased to normal, and the IL-6 dropped to 248 pg/mL. This improvement in control of CRS was mirrored by a gradual and progressive improvement in lung function, as measured by P/F ratio and chest X-rays. On day 12 of admission to the PICU, he was weaned off of mechanical ventilation and was discharged from the ICU a week later.

CAR T-cell immunotherapy (Kymriah® - Novartis; Yescarta® – Gilead) represents a breakthrough in cancer treatment of acute lymphocytic leukemia (ALL; also called acute lymphocytic leukemia) and Diffuse large B-cell lymphoma (DLBCL) that are refractory to standard biologic therapy and chemotherapy, and has great potential in other blood cancers and solid tumors in the future. The therapy takes a patient’s own immune T-cells, genetically modifies them outside of the body with a chimeric antigen receptor (CAR) to be able to recognize and kill the cancer cells, and reinfuses these CAR T-cells back into the body where they have led to dramatic cures of what were considered irreversibly fatal cancers. However, in doing so the activated cells often trigger an inflammatory response in the patient caused by the production of high levels of inflammatory mediators called cytokines. In some patients, the levels of these cytokines can spiral upwards, creating a “cytokine storm” or cytokine release syndrome (CRS) that can rapidly cause multi-organ failure, inflammation of the brain, and potentially death if left untreated. Tocilizumab® (an IL-6 receptor antagonist) and intravenous steroids are the current approved treatments for CRS but are not always successful in controlling CRS or CRES, and have the potential to immune suppress the patient, increasing the risk of serious infection. CytoSorb has the potential to fill this gap. There are currently two approved CAR T-cell immunotherapies in both the United States and European Union. According to Market Research Future, the global CAR T-cell immunotherapy market is expected to approach $9 billion in revenue by 2025.

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 58 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® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. The Company has also initiated the company-sponsored U.K. TISORB trial evaluating the removal of ticagrelor in emergency cardiac surgery patients. CytoSorb® has been used in more than 80,000 human treatments to date.

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 $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), 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.

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, 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 7, 2019, 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:
Amy Vogel

Investor Relations

732-398-5394

avogel@cytosorbents.com

Investor Relations Contact:

Jeremy Feffer

LifeSci Advisors

917-749-1494

jeremy@lifesciadvisors.com

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SOURCE CytoSorbents Corporation