Data Presented on First CytoSorb® Investigator-Initiated Septic Shock Study

Encouraging top line results fuel hopes for potentially life-saving treatment

Feb 26, 2016, 07:00 ET from CytoSorbents Corporation

MONMOUTH JUNCTION, N.J., Feb. 26, 2016 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its flagship CytoSorb® blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, summarized data from the first CytoSorb® investigator-initiated septic shock study presented yesterday at the  26th Symposium for Intensive Medicine + Intensive Care in Bremen, Germany.

Dr. Sigrun Friesecke, Senior Intensivist of the medical intensive care unit (MICU) at Greifswald University in Germany, presented top line data from a prospective, single arm study in 22 patients with refractory late-stage septic shock and multiple organ failure at her institution.  All patients had refractory septic shock despite high doses of vasopressors, respiratory failure requiring artificial ventilation or extracorporeal membrane oxygenation (ECMO), anuric (no urine production) kidney failure requiring dialysis, and a significantly elevated initial mean lactate level of 8 mmol/L, indicating extreme metabolic and physiologic derangement.  In these patients, all intensive care therapeutic options had been exhausted.  Patients underwent consecutive twelve-hour extracorporeal  CytoSorb® treatments over several days, using a new CytoSorb® cartridge for each treatment.

As reported recently by Conrad (2015), a similar patient population (n=16) receiving standard of care treatment with persistent refractory septic shock that could not be reversed, with respiratory failure on mechanical ventilation, initial lactate levels of 6.1 ± 4 mmol/L, and 75% requiring renal replacement therapy had a mortality of 100% at 28 days1.  

Preliminary key findings of the CytoSorb® Greifswald study:

  • 28-day-survival was 41%, an approximately 30-40% absolute improvement in survival compared to what was expected (0-10%)
  • Resolution of shock, the main cause for mortality in this patient population, was achieved in 68% of the patients with CytoSorb® therapy, which translated into improvement in clinical outcomes
  • Reduction of IL-6, one of the cytokines most closely associated with severity of illness, inflammation, and mortality in sepsis, decreased rapidly from initial mean values of approximately 87,000 pg/mL, to below 10,000 pg/mL after 24 hours of treatment

Data analysis continues and more details of this study are expected to submitted for publication in the near future.

Dr. Axel Nierhaus, senior consultant at the Department for Intensive Care Medicine at University of Hamburg - Eppendorf, Germany, who chaired the symposium session, summarized the study as a "significant step to establish CytoSorb as a regular therapy for those moribund patients".

Sepsis is the result of an overzealous immune response to a serious infection often driven by an excessive production of cytokines, or "cytokine storm", and other inflammatory mediators and toxins.  It is one of the leading causes of death and disability worldwide, striking an estimated 27 million people annually and killing a third of them, despite the use of antibiotics and the best medical care.  Septic shock is the most deadly form of the disease, where patients develop persistent, life-threatening low blood pressure that compromises blood and oxygen delivery to vital organs in the body.  Common to all septic shock patients is the need for vasopressors – potent drugs such as norepinephrine, dobutamine, and vasopressin – that attempt to artificially increase blood pressure by increasing cardiac output or shunting blood from non-vital organs and the arms and legs, to the core vital organs.  Patients who require maximal doses of multiple vasopressors represent the most challenging patients with the highest risk of death.  Refractory septic shock, despite the use of vasopressors, often results in irreversible organ injury due to ischemia and other factors.  The expected mortality of patients with prolonged refractory septic shock, particularly when combined with the failure of other organs, approaches 90-100%.  CytoSorb® is designed to reduce the inflammatory toxins that drive uncontrolled, deadly inflammation and refractory shock, and has been used to help stabilize blood pressure and regain control of many patients, particularly when used early and aggressively.

1 Conrad, M., et. al., "Early prediction of norepinephrine dependency and refractory septic shock with a multimodal approach of vascular failure", J Crit Care, 2015; 30:739-743.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorb® is approved in the European Union with distribution in 32 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.  CytoSorb® has been used safely in more than 9,000 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.  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 HemoDefend™, ContrastSorb, DrugSorb, and others.  Additional information is available for download on the Company's websites:  http://www.cytosorbents.com and http://www.cytosorb.com

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Cytosorbents Contact:
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Investor Relations
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avogel@cytosorbents.com


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