CytoSorbents Corporation (CTSO)

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Landmark Publication Underscores Robust Ability of CytoSorb to Reduce Cytokine Storm during Systemic Hyperinflammation

March 29, 2023 08:30 ET | Source: CytoSorbents

"PRINCETON, N.J., March 29, 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, highlights the recently published study entitled, “CytoSorb hemoperfusion markedly attenuates circulating cytokine concentrations during systemic inflammation in humans in vivo” in the renowned medical journal “Critical Care.” In this landmark publication, leading sepsis researchers in the group of Prof. Dr. Peter Pickkers from Radboud University Medical Center, Nijmegen, Netherlands convincingly demonstrate the robust ability of CytoSorb® to rapidly reduce cytokine storm during systemic hyperinflammation in a well-controlled and well-established human experimental sepsis model.

In this clinical study, Jensen, et al., intravenously administered bacterial lipopolysaccharide endotoxin - a dangerous toxin found on the surface of most Gram-negative bacteria such as E. coli, Pseudomonas, and Klebsiella - to twenty-four healthy male volunteers (age 18-35). Endotoxin is a common culprit in sepsis that potently activates the immune system, triggering the high production of cytokines, often called a “cytokine storm,” and severe inflammation. Extracorporeal blood purification with CytoSorb was then used to treat half of the volunteers for a total of 6 hours. Baseline demographic characteristics between those that received CytoSorb therapy and those that did not (control) were similar. All other interventions between the two groups were identical. Cytokine measurements were taken every hour or half-hour throughout the experiment.

Intravenous administration of endotoxin resulted in impressive transient increases in cytokine concentrations in the control group, characteristic of levels seen in a true cytokine storm. Meanwhile, the CytoSorb group had significantly lower plasma levels of cytokines, including TNF (median AUC: -58%, p<0.0001), IL-6 (-71%, p=0.003), IL-8 (-48%, p=0.02), IL-10 (-26%, p=0.03), MCP-1 (-34%, p=0.02) and MIP-1a (-39%, p=0.006), showing that CytoSorb profoundly attenuates the increase in circulating cytokine concentrations during endotoxin-induced systemic inflammation in humans. This result is very clinically relevant, as the severity and duration of cytokine storm and inflammation in sepsis are directly correlated with life-threatening complications such as shock, respiratory failure, and other organ failure, and the risk of death. Importantly, following endotoxin re-challenge seven days later (without blood purification), no differences in cytokine response were observed between the two groups, demonstrating that use of CytoSorb a week earlier did not affect long-term immune function.

Dr. Christian Steiner, Executive Vice President of Sales & Marketing of CytoSorbents, stated, “We are pleased to highlight this most recent publication from Professor Pickkers and colleagues, and were excited to invite Prof. Pickkers to speak on these results at our symposium at last week’s International Symposium on Intensive Care & Emergency Medicine in Brussels, Belgium. The response from current and prospective users has been extremely positive, and has helped to refocus our discussions on how to optimize the way CytoSorb is used to have the strongest effect, such as treating early, as seen in this study. We are very excited by this development and will continue to strive to make CytoSorb Therapy accessible to all patients in need.”

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, added, “The beauty of this study is its simplicity and elegance, demonstrating definitively that CytoSorb reduces cytokine storm in a well-controlled and balanced study that eliminates the heterogeneity and confounding variables that plague clinical trials in critically ill patients. This study corroborates the well-established literature on CytoSorb and cytokine reduction across many different fields over the past decade, and we strongly believe closes any debate on the utility of CytoSorb for this purpose. No other blood purification technology has amassed this level of evidence, helping to establish CytoSorb as the de facto standard for extracorporeal control of cytokine storm and hyperinflammation. Importantly, the use of CytoSorb for this purpose has been directly associated with positive clinical outcomes, such as high 74% survival in 100 critically ill COVID-19 patients when used with ECMO under FDA Emergency Use Authorization, as we reported from our U.S. CytoSorb Therapy in COVID-19 (CTC) Registry, or the reduction in sepsis-related mortality when used intraoperatively in patients with Staph. aureus endocarditis, for example. This is the heart of why CytoSorb has been used across 75 countries in more than 200,000 human treatments around the world to date.”

https://www.globenewswire.com/news-release/2023/03/29/2636667/25359/en/Landmark-Publication-Underscores-Robust-Ability-of-CytoSorb-to-Reduce-Cytokine-Storm-during-Systemic-Hyperinflammation.html


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