Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine
company developing MultiStem® (invimestrocel) cell therapy for
critical care indications, announces patient enrollment has begun
in the third and final cohort in MATRICS-1, the Phase 2 clinical
study evaluating MultiStem® in patients following resuscitation
from hemorrhagic trauma. This study is being conducted at The
University of Texas Health Science Center at Houston (UTHealth
Houston) and Memorial Hermann-Texas Medical Center, a leading
certified Level One Trauma Center, and approximately 140 patients
will be enrolled in cohort three. MATRICS-1 is supported in part by
MTEC (Medical Technology Enterprise Consortium) in partnership with
the Department of Defense, and funding from Memorial Hermann
Foundation.
Patients in the third cohort will be dosed with MultiStem cells
produced under Athersys’ novel 3D bioreactor-based manufacturing
process, a process that was first utilized to produce product for
patients in cohort two of MATRICS-1. MultiStem is believed to
deliver benefit for treating complications due to trauma through
mechanisms including reducing inflammatory damage, protecting
at-risk tissue at the site of injury and upregulating reparative
aspects of the local and systemic immune system in a more timely
way.
“We’re excited to move forward and initiate cohort 3 of this
important trial with our partners at UTHealth Houston,
Hermann-Texas Medical Center and DoD/MTEC based on a positive DSMB
review. MultiStem’s unique mechanism of action has the potential to
address the often fatal complications that occur following a severe
traumatic event. The final cohort will utilize clinical product
manufactured using a 3D bioreactor process and all doses are
readily available through our contract manufacturer,” said Dan
Camardo, Chief Executive Officer of Athersys.
“When administered soon after a traumatic injury, MultiStem
holds potential to reduce the inflammatory cascade and mitigate
secondary tissue damage. With the third cohort now being enrolled,
I’m pleased we have entered the final stretch of our important
research to try to improve trauma outcomes,” said Dr. Charles S.
Cox Jr., the George and Cynthia Mitchell Distinguished Chair in
Neurosciences and the Glassell Family Distinguished Chair in the
Department of Pediatric Surgery with McGovern Medical School at
UTHealth Houston, who is Principal Investigator of the study at the
Memorial Hermann-Texas Medical Center site.
The MATRICS-1 double-blind, placebo-controlled Phase 2 study is
evaluating the safety and effectiveness of MultiStem for the
prevention and early treatment of complications after severe
traumatic injury. The study is enrolling severely injured trauma
patients who have survived initial treatment and are admitted to
the intensive care unit, where they are randomized to receive
MultiStem or placebo within hours of hospitalization, along with
standard of care.
About MultiStem®
MultiStem® (invimestrocel) cell therapy is a patented
regenerative medicine product in clinical development that has
shown the ability to promote tissue repair and healing in a variety
of ways, such as through the production of therapeutic factors in
response to signals of inflammation and tissue damage. MultiStem
therapy’s potential for multidimensional therapeutic impact
distinguishes it from traditional biopharmaceutical therapies
focused on a single mechanism of benefit. The therapy represents a
unique "off-the-shelf" stem cell product that can be manufactured
in a scalable manner, may be stored for years in frozen form, and
is administered without tissue matching or the need for immune
suppression. Based upon its efficacy profile, its novel mechanisms
of action, and a favorable and consistent tolerability demonstrated
in clinical studies, we believe that MultiStem therapy could
provide a meaningful benefit to patients, including those suffering
from serious diseases and conditions with unmet medical need.
About UTHealth Houston
Established in 1972 by The University of Texas System Board of
Regents, The University of Texas Health Science Center at Houston
(UTHealth Houston) is Houston’s Health University and Texas’
resource for health care education, innovation, scientific
discovery and excellence in patient care. The most comprehensive
academic health center in the UT System and the U.S. Gulf Coast
region, UTHealth Houston is home to Jane and Robert Cizik School of
Nursing, John P. and Kathrine G. McGovern Medical School, D.
Bradley McWilliams School of Biomedical Informatics, and schools of
biomedical sciences, dentistry, and
public health. UTHealth Houston includes the UTHealth Harris County
Psychiatric Center, as well as the growing clinical practices UT
Physicians, UTHealth Neurosciences, UT Dentists, and UT Health Services. The university’s primary
teaching hospitals are Memorial Hermann-Texas Medical Center,
Children’s Memorial Hermann Hospital,
and Harris Health Lyndon B. Johnson Hospital. For more information,
visit www.uth.edu.
About Memorial Hermann Health System
Charting a better future. A future that’s built upon the HEALTH
of our community. This is the driving force for Memorial Hermann,
redefining health care for the individuals and many diverse
populations we serve. Our 6,700 affiliated physicians and 32,000
employees practice the highest standards of safe, evidence-based,
quality care to provide a personalized and outcome-oriented
experience across our more than 260 care delivery sites. As one of
the largest not-for-profit health systems in Southeast Texas,
Memorial Hermann has an award-winning and nationally acclaimed
Accountable Care Organization, 17* hospitals and numerous specialty
programs and services conveniently located throughout the Greater
Houston area. Memorial Hermann-Texas Medical Center is one of the
nation's busiest Level I trauma centers and serves as the primary
teaching hospital for McGovern Medical School at UTHealth. For more
than 115 years, our focus has been the best interest of our
community, contributing nearly $500 million annually through
school-based health centers and other community benefit programs.
Now and for generations to come, the health of our community will
be at the center of what we do – charting a better future for
all.
*Memorial Hermann Health System owns and operates 14 hospitals
and has joint ventures with three other hospital facilities,
including Memorial Hermann Surgical Hospital First Colony, Memorial
Hermann Surgical Hospital Kingwood and Memorial Hermann
Rehabilitation Hospital-Katy.
About Athersys
Athersys is a biotechnology company engaged in the discovery and
development of therapeutic product candidates designed to extend
and enhance the quality of human life. The Company is developing
its MultiStem® cell therapy product, a patented, adult-derived
“off-the-shelf” stem cell product, initially for disease
indications in the neurological, inflammatory and immune, and other
critical care indications and has several ongoing clinical trials
evaluating this potential regenerative medicine product. Athersys
has forged strategic partnerships and a broad network of
collaborations to further advance MultiStem cell therapy toward
commercialization. Investors and others should note that we may
post information about the Company on our website at
www.athersys.com and/or on our accounts on Twitter, Facebook,
LinkedIn or other social media platforms. It is possible that the
postings could include information deemed to be material
information. Therefore, we encourage investors, the media and
others interested in the Company to review the information we post
on our website at www.athersys.com and on our social media
accounts. Follow Athersys on Twitter at www.twitter.com/athersys.
Information that we may post about the Company on our website
and/or on our accounts on Twitter, Facebook, LinkedIn or other
social media platforms may contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 that involve risks and uncertainties. You should not place
undue reliance on forward-looking statements contained on our
website and/or on our accounts on Twitter, Facebook, LinkedIn or
other social media platforms, and we undertake no obligation to
publicly update forward-looking statements, whether as a result of
new information, future events or otherwise.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. These forward-looking
statements relate to, among other things, the expected timetable
for development of our product candidates, our growth strategy, and
our future financial performance, including our operations,
economic performance, financial condition, prospects, and other
future events. We have attempted to identify forward-looking
statements by using such words as “anticipates,” “believes,” “can,”
“continue,” “could,” “estimates,” “expects,” “intends,” “may,”
“plans,” “potential,” “should,” “suggest,” “will,” or other similar
expressions. These forward-looking statements are only predictions
and are largely based on our current expectations. In addition, a
number of known and unknown risks, uncertainties, and other factors
could affect the accuracy of these statements. Some of the more
significant known risks that we face are the risk that we will be
unable to raise capital to fund our operations in the near term and
long term, including our ability to obtain funding through public
or private equity offerings, debt financings, collaborations and
licensing arrangements or other sources, on terms acceptable to us
or at all, and to continue as a going concern and our ability to
successfully resolve the payment issues with our primary contract
manufacturer and gain access to our clinical product. The following
risks and uncertainties may cause our actual results, levels of
activity, performance, or achievements to differ materially from
any future results, levels of activity, performance, or
achievements expressed or implied by these forward-looking
statements: our ability to raise capital to fund our operations in
the near term and long term, including our ability to obtain
funding through public or private equity offerings, debt
financings, collaborations and licensing arrangements or other
sources, on terms acceptable to us or at all, and to continue as a
going concern; our ability to successfully license our SIFU
technology; our collaborators’ ability and willingness to continue
to fulfill their obligations under the terms of our collaboration
agreements and generate sales related to our technologies; the
possibility of unfavorable results from ongoing and additional
clinical trials involving MultiStem; the risk that positive results
in a clinical trial may not be replicated in subsequent or
confirmatory trials or success in an early stage clinical trial may
not be predictive of results in later stage or large scale clinical
trials; our ability to regain compliance with the Nasdaq continued
listing requirements; the timing and nature of results from
MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical
trial evaluating the administration of MultiStem for the treatment
of ischemic stroke; our ability to meet milestones and earn
royalties under our collaboration agreements, including the success
of our collaboration with Healios; the success of our MACOVIA
clinical trial evaluating the administration of MultiStem for the
treatment of ARDS induced by COVID-19 and other pathogens, and the
MATRICS-1 clinical trial being conducted with The University of
Texas Health Science Center at Houston evaluating the treatment of
patients with serious traumatic injuries; the availability of
product sufficient to meet our clinical needs and potential
commercial demand following any approval; the possibility of delays
in, adverse results of, and excessive costs of the development
process; our ability to successfully initiate and complete clinical
trials of our product candidates; the possibility of delays, work
stoppages or interruptions in manufacturing by third parties or us,
such as due to material supply constraints, contamination,
operational restrictions due to COVID-19 or other public health
emergencies, labor constraints, regulatory issues or other factors
that could negatively impact our trials and the trials of our
collaborators; uncertainty regarding market acceptance of our
product candidates and our ability to generate revenues, including
MultiStem cell therapy for neurological, inflammatory and immune,
cardiovascular and other critical care indications; changes in
external market factors; changes in our industry’s overall
performance; changes in our business strategy; our ability to
protect and defend our intellectual property and related business
operations, including the successful prosecution of our patent
applications and enforcement of our patent rights, and operate our
business in an environment of rapid technology and intellectual
property development; our possible inability to realize
commercially valuable discoveries in our collaborations with
pharmaceutical and other biotechnology companies; the success of
our efforts to enter into new strategic partnerships and advance
our programs; our possible inability to execute our strategy due to
changes in our industry or the economy generally; changes in
productivity and reliability of suppliers; the success of our
competitors and the emergence of new competitors; and the risks
mentioned elsewhere in our Annual Report on Form 10-K for the year
ended December 31, 2021 under Item 1A, “Risk Factors” and our other
lings with the SEC. You should not place undue reliance on
forward-looking statements, and we undertake no obligation to
publicly update forward-looking statements, whether as a result of
new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230531005935/en/
Athersys Ellen Gurley Manager of Corporate Communications
and Investor Relations ir@athersys.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
Athersys (NASDAQ:ATHX)
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