MONMOUTH JUNCTION, N.J.,
April 24, 2017 /PRNewswire/ --
CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy leader using blood purification to treat deadly
inflammation in critically-ill and cardiac surgery patients around
the world, announced that it was awarded a two-year $999,996 Small Business Innovation Research
(SBIR) Phase II contract to continue development of CytoSorb® for
fungal mycotoxin blood purification. This follows the successful
completion of its previously announced $150,000 Phase I SBIR contract for mycotoxin
removal. This contract is funded through the Chemical and
Biological Defense (CBD) SBIR Program which represents a component
of the Joint Chemical and Biological Defense Science &
Technology Program. This SBIR project is being managed by the
Joint Program Executive Office for Chemical and Biological Defense
(JPEO-CBD), the U.S. Department of Defense focal point for
research, development, acquisition, fielding, & life-cycle
support of Chemical, Biological, Radiological, Nuclear (CBRN)
equipment and medical countermeasures.
Mycotoxins derived from naturally-occurring fungi can be
weaponized as highly toxic biological warfare agents. Accidental or
intentional exposure to mycotoxins, such as aflatoxin and T-2
toxin, can lead to acute liver failure, severe end-organ injury,
bleeding, neurologic damage, coma, and death. The Phase II
SBIR program will focus on demonstrating the ability of CytoSorb to
adsorb mycotoxins in vivo and improve survival in
animals.
"We greatly appreciate the support of JPEO-CBD and are excited
to accelerate the development of CytoSorb as a countermeasure for
mycotoxin exposure," stated Dr. Phillip P.
Chan, Chief Executive Officer of CytoSorbents. "If
successful, this could represent a significant advance in the
protection of our troops and civilians against these deadly
toxins. In addition, it would provide key data supporting the
use of CytoSorb to help treat fungal infections, a dreaded cause of
approximately a quarter of all hospital-acquired infections that
are extremely difficult to treat and where death is common.
Anti-fungal therapeutics have a global market of over $10 billion annually."
Dr. Thomas D. Golobish, PhD,
Co-Principal Investigator and Senior Director of Polymer
Development at CytoSorbents added, "In the Phase I SBIR program, we
demonstrated the rapid and robust reduction of aflatoxin and T-2
mycotoxin from whole blood in vitro. Coupled with the
ability of CytoSorb® to reduce a broad range of pathogenic toxins
and inflammatory mediators such as cytokines from blood, as well as
toxins such as bilirubin that can accumulate in acute liver
failure, we believe CytoSorb may have a synergistic benefit in
mycotoxin exposure and fungal sepsis."
CytoSorbents' advanced development program is entitled
"Mycotoxin Adsorption with Hemocompatible Porous Polymer Beads,"
and funded under JPEO-CBD contract number W911QY-17-C-0007.
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.
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. 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™, 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.
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
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Public Relations
Contact:
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Phillips
Pascale Communications
412-327-9499
amy@pascalecommunications.com
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SOURCE CytoSorbents Corporation