CytoSorbents from Monmouth Junction, New Jersey has received European regulatory approval for its CytoSorb cytokine filter. The company hopes that its extracorporeal device might one day become a treatment option in critical patients whose cytokine levels are elevated, such as in cases of sepsis, ARDS, burns, etc.
From the announcement:
The European Sepsis Trial has successfully demonstrated CytoSorb™’s robust ability to reduce circulating plasma cytokine levels during the extracorporeal treatment of critically-ill patients with sepsis and respiratory failure. CytoSorb™ has achieved its primary endpoint of IL-6 (interleukin-6) reduction with statistical significance based on an interim analysis of the trial. The data demonstrates that CytoSorb™ plus standard of care therapy reduced IL-6 levels by an average of 49.1% (p = 0.01) during the CytoSorb™ treatment period compared to standard of care therapy alone. The treatment was well-tolerated, with no serious device related adverse events reported to date in more than 300 treatments in septic patients.
Dr. Phillip Chan, Chief Executive Officer, stated, "Obtaining European regulatory approval for CytoSorb™ is the most significant accomplishment in our company’s history and we thank our employees and our shareholders for their dedication and support. To our knowledge, we are the only device approved in the E.U. specifically as a cytokine filter, opening up many opportunities to not just treat patients with sepsis, but also patients with a host of life-threatening and non-life threatening inflammatory conditions where cytokine levels are elevated. As we analyze the clinical data from our current trial in sepsis, we look to continue to lead and foster additional clinical studies with a strong focus on sepsis and other critical care illnesses such as acute respiratory distress syndrome, severe burn injury, trauma, and pancreatitis, where the need is great and the human and financial costs are staggering. The goal is to drive broad usage of our technology and generate valuable clinical data across many fields."
We believe the company has a long rope to climb before it obtains FDA approval. Not only do cytokines have a very complex involvement in inflammatory processes, there is also a possibility that suppression or elimination of cytokines could have serious negative consequences on immune surveillance. In addition, it doesn’t make us optimistic to know of all the dismal results from multiple efforts to develop anti-cytokine bioengineered molecules with positive therapeutic effects in critical patients, and even in animal models.
Press release: CytoSorbents Corporation Achieves European Union Regulatory Approval for CytoSorb™
Product page: CytoSorb…
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