First Study to Evaluate CytoSorb in Cytokine Release Syndrome (CRS) Following CAR T-cell Immunotherapy to Commence

First Study to Evaluate CytoSorb in Cytokine Release Syndrome (CRS)

Following CAR T-cell Immunotherapy to Commence

JUNCTION, NJ - September 16, 2019 - 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 that Hannover

Medical School in Germany will begin the first clinical study called CYTORELEASE,

evaluating the use of CytoSorb in treating CRS and inflammation of the brain called CAR-related Encephalopathy Syndrome (CRES),

following CAR-T cell immunotherapy.

trial, entitled "Effectivity of Extracorporeal Cytokine Adsorption (CytoSorb) as

Additive Treatment of CAR-T Cell Associated Cytokine Release Syndrome (CRS) and Encephalopathy Syndrome (CRES),"

is a randomized, controlled pilot study in 34 cancer patients who have received CAR-T cell immunotherapy and who have developed

either severe CRS or CRES for a duration less than 6 hours. Patients will receive either standard of care therapy versus standard

of care therapy plus CytoSorb hemoadsorption. The primary endpoint of the study is a plasma reduction of the pro-inflammatory

cytokine interleukin-6 (IL-6). Secondary and exploratory endpoints will examine other potential clinical benefits such as improvements

in CRES, shock, and other organ injury. The trial has been approved by the Hannover Medical School

ethics committee and is ready to begin enrollment.

Principal Investigator Dr. med. Sascha

David, Medicine, Division of Nephrology at Hannover Medical School, stated, "We are excited by the theoretical rationale

of cytokine adsorption with CytoSorb in treating severe CRS and CAR T-cell related Encephalopathy Syndrome (CRES). CytoSorb's

potential impact on severe CRES is of special interest, given that CRES is a common and sometimes life-threatening complication

of CAR T-cell therapy that is not adequately addressed by IL-6 blockade. I am looking forward to the results of our first randomized,

controlled pilot study."

immunotherapy represents a breakthrough in cancer treatment of acute lymphocytic leukemia (ALL) 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:

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. CytoSorb has been used in more than 67,000 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 nearly $26 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

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