MONMOUTH JUNCTION, N.J.,
March 20, 2017 /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, highlights recent cases using
CytoSorb to successfully treat HLH (hemophagocytic
lymphohistiocytosis) and their relevance to cytokine release
syndrome (CRS) in cancer immunotherapy.
Cancer immunotherapies manipulate a patient's own immune system
to attack and kill cancer cells. Examples of FDA-approved
products or strategies under development include single and
bispecific monoclonal antibodies, checkpoint inhibitors,
therapeutic cancer vaccines, and adoptive T-cell transfer
approaches using either chimeric antigen receptor T-cells (CAR
T-cells) or T-cell receptor therapies. Many of these
therapies have led to immune system activation and a robust tumor
response, resulting in impressive complete or partial response
rates and disease-free survival, even in patients that had
previously failed all other therapy.
However, tight control of the immune response has been
challenging, often resulting in immune system over-activation and
excessive cytokine production called cytokine release syndrome, or
CRS. Reported in up to 50% of patients in some studies, this
cytokine-mediated toxicity can range from mild, to severe and
life-threatening. Patients with severe CRS develop hallmark
findings including high fever, high levels of cytokines,
significantly elevated ferritin, coagulopathy and very low
platelets, an enlarged liver and spleen, and ultimately some degree
of multi-organ dysfunction and failure that can progress to
death. When treated quickly, patients may respond to
anti-cytokine therapies such as the IL-6 receptor antagonist,
tocilizumab, or to immunosuppressive agents such as high dose
steroids. However, these agents are not always effective, and
steroids can compromise the viability or efficacy of the
immunotherapy.
When CRS was first described, researchers noted the remarkable
similarity to two related disorders called hemophagocytic
lymphohistiocytosis (HLH) and macrophage activating syndrome
(MAS). In particular, the clinical, physical, laboratory, and
inflammatory biomarker profiles in all three conditions overlap
significantly. In all of these diseases, many different types
of white blood cells are activated, releasing inflammatory
cytokines and creating a cytokine storm that then leads to rapid
patient deterioration which is extremely difficult to manage.
Between the familial HLH and secondary HLH triggered by infection
(most commonly viral), the latter is more common, though both are
relatively rare and often fatal, with steroids, immunosuppressive
drugs, and anti-cytokine therapies often ineffective.
Despite the relative infrequency of HLH, we have now treated 10
secondary HLH patients with CytoSorb, with 3 published case reports
and others pending. This month in the Journal of Clinical
Immunology, in a case report entitled, "Rescue of Cytokine Storm
Due to HLH by Hemoadsorption in a CTLA4-Deficient Patient", Greil
and colleagues report the use of CytoSorb in successfully treating
a 50-year old man with secondary HLH due to Epstein Barr virus
(EBV) infection and associated Hodgkin's lymphoma, and complicated
by CTLA-4 deficiency. CTLA-4 deficiency is a
genetic disorder that eliminates a key regulatory control element
of cellular immunity and predisposes patients to severe
inflammation. This patient was initially admitted for
recurrent fevers, and was subsequently found to have a high grade
EBV infection that triggered HLH, with kidney failure
(requiring dialysis), liver failure, respiratory failure (requiring
mechanical ventilation), shock (requiring vasopressors), and high
inflammatory cytokines and other biomarkers. Despite the use
of conventional HLH therapy, including high dose steroids,
etoposide, and rituximab due to EBV infection, the patient worsened
with progressive multi-organ failure. At that time, treatment
with CytoSorb was initiated, subsequently treating for 4
consecutive days, each day with a new cartridge. According to the
investigators, CytoSorb use resulted in an immediate decrease in
inflammatory markers with a simultaneous immediate improvement in
clinical condition, with the patient discharged from the ICU in
stable condition, nine days after the start of CytoSorb
therapy.
This case follows other successful CytoSorb treatments in herpes
simplex virus-induced HLH in a patient with fulminant liver
failure, rapid clinical improvement in an HIV positive patient with
EBV-induced HLH, and others pending submission or
publication. The success of CytoSorb treatment in a growing
number of secondary HLH patients provides a clear rationale to
treat CRS. We have met with many immuno-oncology companies
and have been invited to present to the immunotherapy sections and
critical care units at several major cancer immunotherapy clinical
trial sites. In our discussions, we have confirmed the
interest in the therapy, once available, as an adjunct to
tocilizumab, and before high dose steroids are administered.
We plan to continue to pursue applications of our therapy in the
treatment of CRS in the United
States, Europe, and
elsewhere, as cancer immunotherapies continue to expand worldwide.
CytoSorb is approved in the European Union, but is not yet
approved in the United States.
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 43 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 of 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 20,000
human treatments to date. A companion product, VetResQ™,
based on similar underlying technology to CytoSorb, is now
commercially available in the United
States for the treatment of hyper-inflammatory conditions in
animal health.
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 in excess of $18 million from DARPA, the U.S. Army, the U.S.
Air Force, 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
31 issued U.S. patents and multiple applications pending, including
CytoSorb-XL, HemoDefend™, ContrastSorb, DrugSorb, and others. For
more information, please visit the Company's websites at
www.cytosorbents.com and www.cytosorb.com or follow us
on Facebook and Twitter.
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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
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Cytosorbents
Contact: Amy Vogel
Investor
Relations
(732)
398-5394
avogel@cytosorbents.com
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Pascale Communications
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amy@pascalecommunications.com
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SOURCE CytoSorbents Corporation