PRINCETON, N.J., Nov. 14,
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 40 of the targeted 120 patients have
been enrolled in the Safe and Timely
Antithrombotic Removal – Ticagrelor
(STAR-T) trial, achieving the first enrollment milestone and
triggering a pre-specified Data and Safety Monitoring Board (DSMB)
review. This pivotal study intends to support both U.S. FDA
and Health Canada marketing approval of DrugSorb-ATR in
the United States and Canada, respectively, to remove the
anti-thrombotic agent, ticagrelor (Brilinta®, AstraZeneca), during
cardiothoracic surgery.
CytoSorbents' pivotal STAR-T trial using
DrugSorb-ATR to remove ticagrelor during cardiac surgery now a
third complete
Dr. Michael J. Mack, Director of
the Cardiovascular Service line at Baylor Scott & White Health
System, Chairman of the Baylor Plano Research Center in
Texas and co-Principal
Investigator of the STAR-T trial commented: "Reaching our first
trial enrollment milestone of 40 patients is a critical first step
in the execution of the landmark STAR-T trial. Currently, cardiac
surgeons are either forced to delay life-saving heart surgery in
patients who are on antithrombotic drugs or proceed to operation
when they are at very high risk for bleeding. The DrugSorb-ATR
device is a novel approach that could potentially allow these
high-risk surgeries to proceed in a safe and timely manner. We have
designed two rigorous, pivotal trials to test the efficacy and
safety of this novel device that if successful could make it
available to all U.S. cardiac surgeons, so they can join their
international colleagues who have it available and use it routinely
in their everyday practice. We are currently focused on bringing
the STAR-T trial across the finish line, so we can then turn our
attention to STAR-D. I'd like to thank all of the participating
centers and investigators for helping us reach this first crucial
enrollment milestone and we remain very excited to welcome our
Canadian colleagues who should begin contributing to enrollment
very soon."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "We are pleased to have enrolled a third of
our STAR-T pivotal study, which now triggers the first safety
review by the independent DSMB of the study. We are now
working diligently to complete the necessary operational steps
including data collection and validation to support the upcoming
DSMB safety review which is estimated in approximately 2 months.
With our full attention and resources now dedicated to STAR-T
and the upcoming addition of Canadian sites, we anticipate the
momentum to continue and project that we can achieve the next study
milestone of 80 patients enrolled in Spring 2023 that will trigger
the next DSMB safety review and the pre-specified interim
analysis.
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 30 centers 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 intends to support both U.S. FDA
and Health Canada marketing approval of DrugSorb-ATR in
the United States and Canada, respectively, for this
application. The STAR-T trial will be followed by the
STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral
Anticoagulants) pivotal trial evaluating the intraoperative use of
DrugSorb-ATR to reduce perioperative bleeding risk in patients
undergoing cardiothoracic surgery and taking direct oral
anticoagulants, including apixaban and rivaroxaban.
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.
Please Click to Follow Us on Facebook and Twitter
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com
Public Relations Europe:
Marcus Schult
commponists
+49 69 13823 ext. 960
+49 172 4238938
marcus.schult@die-kommponisten.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cytosorbents-announces-pivotal-star-t-trial-reaches-first-milestone-with-40-patients-enrolled-301676656.html
SOURCE CytoSorbents Corporation