CytoSorbents Release: Key Clinical Study Showing Reversal Of Refractory Septic Shock In Patients Treated With CytoSorb

Published: Sep 26, 2017

MONMOUTH JUNCTION, N.J., Sept. 25, 2017 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using CytoSorb® blood purification to treat deadly inflammation in critically ill and cardiac surgery patients around the world, highlighted the recent publication of a study entitled "Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study" in the Journal of Artificial Organs

CytoSorbents Logo. (PRNewsFoto/CytoSorbents)

Study Design and Results

This single center, prospectively defined study evaluated the use of CytoSorb® in twenty consecutive patients with refractory septic shock - a subset of critically ill septic patients that suffer from dangerously low blood pressure despite optimum available therapy.  Persistently low blood pressure deprives vital organs of blood flow and oxygen, leading to a dire situation where multiple organ failure and death are often inevitable.  If not reversed, approximately 80-100% of refractory shock patients will die.

Patients in this study had multiple organ failure and a high severity of illness prior to treatment.

  • All had refractory shock on high doses of vasopressors, such as noradrenaline, with an average lactate of 8.5±6.2 mmol/L, demonstrating poor circulation and oxygen delivery to the body
  • All had kidney failure with little to no urine output, requiring renal replacement therapy (i.e. hemodialysis or hemofiltration) 
  • All had respiratory failure,  requiring mechanical ventilation
  • Patients had an average plasma interleukin-6 (IL-6) of 25,523 pg/mL, consistent with a true hyper-inflammatory cytokine storm
  • Patients had an average Simplified Acute Physiology Score (SAPS II) of 70.4±10.9, predicting a mortality of greater than 80%

CytoSorb treatment was initiated after standard therapy failed to treat septic shock (mean 7.8±3.7 hours of resuscitative effort) and continued for an average total of 3.0±1.5 treatments. The study concluded:

  • A statistically significant reduction in the noradrenaline dose requirement from baseline requirements (the study's primary endpoint) after 6 hours (-0.4 µg/kg/min; p = 0.03), 12 hours (-0.6 µg/kg/min; p = 0.001), and extending to 36 hours (-1.1 µg/kg/min; p < 0.001)
  •  A significant improvement in lactate clearance with CytoSorb treatment, reflecting improved microcirculation and tissue perfusion, and decreased global hypoxia
  • A significant improvement of hemodynamics resulting in shock reversal in 13 out of 20 patients (65%) with CytoSorb treatment
  • A 28-day survival rate of 45%. The predicted survival of the included patients was 0-20%

"These strong results hold promise of CytoSorb as a new therapy for refractory septic shock, a disease whose unfortunate typical outcome has been death.  The ability to reverse shock and improve survival in such a critically ill patient population is remarkable." stated Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents. "We plan to confirm these positive outcomes in a future multi-center, randomized, controlled study."

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 44 countries around the world, as a safe and effective 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 such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. 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, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial a multi-center, randomized controlled study that has demonstrated the safety and efficacy of free hemoglobin reduction with intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery.  In 2017, the Company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval.  CytoSorb® has been used safely in more than 27,000 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 $20 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 32 issued U.S. 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, and 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 3, 2017, 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:
Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com

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Joshua Berkman
Rubenstein Public Relations
212-805-3055    
jberkman@rubensteinpr.com

 

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SOURCE CytoSorbents Corporation

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