PRINCETON, N.J., Dec. 21,
2022 /PRNewswire/ -- CytoSorbents Corporation
(NASDAQ: CTSO), a leader in the treatment of life-threatening
conditions in the intensive care unit and cardiac surgery using
blood purification via its proprietary polymer adsorption
technology, announced that it has received the recommendation from
the independent Data and Safety Monitoring Board (DSMB) to continue
the pivotal Safe and Timely Antithrombotic
Removal – Ticagrelor (STAR-T) trial as planned
without any modifications.
Independent DSMB reviews unblinded data and
recommends STAR-T study continue unchanged after first enrollment
milestone
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents commented, "The independent DSMB has completed the
review of the full unblinded dataset from the first 40 patients
enrolled in the STAR-T trial and we are very pleased to receive the
recommendation to continue the study as planned without any
modifications. All our clinical resources continue to focus
on enrollment with the goal of achieving the next milestone of 80
patients enrolled by Spring 2023, triggering another safety review
and the execution of the trial's prespecified interim analysis by
the independent DSMB."
The STAR-T randomized, controlled trial is a 120-patient, 30
center pivotal study designed to evaluate the ability of
DrugSorb-ATR® to reduce perioperative bleeding by removing the
antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in
patients undergoing cardiothoracic surgery. Brilinta is one
of the leading "blood thinners" used as part of dual-antiplatelet
therapy in patients suspected of having a heart attack. But
if the patient is one of the up to 10% that need to undergo
coronary artery bypass graft (CABG) or other open heart
surgery,
the risk of major fatal or life-threatening CABG-related bleeding
can be as high as 50-65%, particularly if the surgery is
performed within several days of the last Brilinta dose.
Waiting in the hospital to wash out the drug is the
only acceptable alternative, but this comes at high cost and
potential clinical risk. The goal of DrugSorb-ATR is to allow
patients to get the critical surgery they need without delay, while
reducing or preventing this bleeding risk by actively removing the
drug during the surgery. DrugSorb-ATR has received FDA
Breakthrough Device Designation for this indication. The
STAR-T pivotal study is being conducted by many of the leading
cardiothoracic surgery centers in North
America and is intended to support U.S. FDA and Health
Canada marketing approval for DrugSorb-ATR in this
application.
About CytoSorbents Corporation
(NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit and in
cardiac surgery through blood purification. Its lead product,
CytoSorb®, is approved in the European Union and distributed in 75
countries worldwide. It is an extracorporeal cytokine adsorber that
reduces "cytokine storm" or "cytokine release syndrome" in common
critical illnesses that can lead to massive inflammation, organ
failure and patient death. In these diseases, the risk of
death can be extremely high, and there are few, if any, effective
treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove inflammatory mediators that can
lead to postoperative complications, including multiple organ
failure. As of September 30,
2022, more than 186,000 CytoSorb devices have been used
cumulatively. CytoSorb was originally launched in the
European Union under CE mark as the first cytokine adsorber.
Additional CE mark extensions were granted for bilirubin and
myoglobin removal in clinical conditions such as liver disease and
trauma, respectively, and for ticagrelor and
rivaroxaban removal in cardiothoracic surgery
procedures. CytoSorb has also received FDA Emergency Use
Authorization in the United
States for use in adult critically ill COVID-19 patients
with impending or confirmed respiratory failure. The
DrugSorb™-ATR antithrombotic removal system, based on the same
polymer technology as CytoSorb, also received two FDA Breakthrough
Device Designations, one for the removal of ticagrelor and
another for the removal of the direct oral anticoagulants (DOAC)
apixaban and rivaroxaban in a cardiopulmonary bypass circuit
during urgent cardiothoracic procedures. The Company is
currently conducting the FDA-approved, randomized, controlled
STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of
120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use
of DrugSorb-ATR can reduce the perioperative risk of bleeding in
patients receiving ticagrelor and undergoing cardiothoracic
surgery. This pivotal study is intended to support FDA
marketing approval in the United
States and Health Canada marketing approval for DrugSorb-ATR
in this application.
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
$48 million from DARPA, the U.S.
Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special
Operations Command (SOCOM), Air Force Material Command (USAF/AFMC),
and others. The Company has numerous marketed products and
products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and registered trademarks, and multiple
patent applications pending, including ECOS-300CY®, CytoSorb-XL™,
HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb™-ATR, ContrastSorb, 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, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
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