Phase 2 study of cell therapy in trauma
expands Company’s clinical programs focused on critical
care
Athersys, Inc. (NASDAQ: ATHX) announced today that the U.S. Food
and Drug Administration (FDA) has authorized an Investigational New
Drug (IND) application to initiate a Phase 2 clinical trial
evaluating Athersys’ MultiStem® cell therapy for early treatment of
traumatic injuries and the subsequent complications that result
following severe trauma. Memorial Hermann-Texas Medical Center in
Houston, Texas, one of the busiest Level 1 trauma centers in the
United States, intends to conduct the trial. The study represents
another important application of the company’s MultiStem cell
therapy in the critical care area, targeting the severe
inflammatory responses associated with poor outcomes.
The objective of the clinical study is to evaluate the safety
and effectiveness of MultiStem for the treatment of severely
injured patients for the prevention and mitigation of complications
that can result following severe traumatic injury. The proposed
study will be a randomized, double-blind, placebo-controlled Phase
2 clinical trial estimated to enroll approximately 150 severely
injured trauma patients following hospitalization, initial
treatment and admission to the intensive care unit. These patients
will be randomly assigned to receive MultiStem or placebo and both
groups will receive the standard of care for their injuries.
A frequent complication following trauma is the occurrence of
Systemic Inflammatory Response Syndrome (SIRS), which can
contribute to organ failure or other severe complications.
MultiStem has shown promise in reducing the hyperinflammatory
response that occurs in a range of situations, by upregulating key
reparative mechanisms that may reduce complications and
meaningfully improve patient recovery.
“We are appreciative of the FDA’s efforts and their timely
feedback on the trauma IND, especially in light of all of the
demands on the agency related to the COVID-19 pandemic. We are
excited to collaborate with our colleagues at UTHealth and at
Memorial Hermann to evaluate the potential for safety and efficacy
of MultiStem cell therapy for treating patients that have sustained
a severe traumatic injury,” stated Dr. Robert W. Mays, Vice
President of Regenerative Medicine at Athersys. “Based on results
from previous clinical experience evaluating MultiStem in other
critical care indications, such as ischemic stroke and acute
respiratory distress syndrome, as well as published studies in
models of traumatic brain injury, spinal cord injury and other
forms of trauma, we believe that the early administration of
MultiStem cells can meaningfully mitigate, or lessen, the overt and
often detrimental inflammatory cascade that results from the
activation of the immune system following occurrence of traumatic
injury.
“We believe that the timely administration of our MultiStem cell
therapy, regardless of the nature of the acute injury, could lead
to fewer complications, quicker recoveries and a better long-term
outcome for patients,” added Dr. Mays. “The authorization of this
study by the FDA is an important step forward that will help us
better understand the potential of our technology in this clinical
indication.”
As previously disclosed, this study is being supported under a
grant awarded to UTHealth’s McGovern Medical School from the
Medical Technology Enterprise Consortium (MTEC). Also, Memorial
Hermann Foundation will provide additional funding. The study will
be conducted under an Athersys IND, and Athersys will provide the
investigational clinical product for the conduct of the trial, as
well as regulatory and operational support. The trial protocol
authorized by the FDA will be reviewed by the UTHealth
Institutional Review Board to provide approval before trial
initiation.
According to the Centers for Disease Control (CDC), trauma is
the leading cause of death for individuals under the age of 45 and
the third leading cause of death in the U.S., accounting for
approximately 180,000 fatalities each year. It is also a leading
cause of serious disability, especially among young people and
members of the military that suffer trauma. According to
independent research there are more than 31 million instances of
non-fatal injury related hospitalizations annually.1
1Zonfrillo, M.R., Spicer, R.S., Lawrence, B.A. et al. Incidence
and costs of injuries to children and adults in the United States.
Inj. Epidemiol. 5, 37 (2018).
https://doi.org/10.1186/s40621-018-0167-6
About MultiStem®
MultiStem® cell therapy is a patented regenerative medicine
product candidate 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 may distinguish
it from traditional biopharmaceutical therapies focused on a single
mechanism of benefit. MultiStem represents a unique "off-the-shelf"
stem cell product candidate 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 favorable efficacy data, its novel mechanisms of action, and
favorable and consistent tolerability data 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 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,
cardiovascular 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 the MultiStem
cell therapy toward commercialization. More information is
available at www.athersys.com. Follow Athersys on Twitter at
www.twitter.com/athersys.
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. 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 that could cause actual
results to differ materially from those implied by forward-looking
statements are the risks and uncertainties inherent in the process
of discovering, developing, and commercializing products that are
safe and effective for use as therapeutics, including the
uncertainty regarding market acceptance of our product candidates
and our ability to generate revenues. These risks 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. Other important factors to consider in
evaluating our forward-looking statements include: the success of
the Phase 2 clinical trial evaluating MultiStem for early treatment
of trauma to be conducted by the Memorial Hermann-Texas Medical
Center, the success of our MACOVIA study; our ability to raise
capital to fund our operations; our ability to successfully
finalize and implement an alliance with BARDA, and the terms of any
such alliance, including the amount, if any, of funding that we
might receive; the timing and nature of results from MultiStem
clinical trials, including our MASTERS-2 Phase 3 clinical trial and
the HEALIOS K.K. (Healios) TREASURE and ONE-BRIDGE clinical trials
in Japan; the impact on our business, results of operations and
financial condition from the ongoing and global COVID-19 pandemic,
or any other pandemic, epidemic or outbreak of infectious disease
in the United States; 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 or regulatory issues, which 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 the treatment of ischemic stroke, ARDS, acute
myocardial infarction and trauma, and the prevention of
graft-versus-host disease and other disease 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; our ability to
meet milestones and earn royalties under our collaboration
agreements, including the success of our collaboration with
Healios; our collaborators’ ability to continue to fulfill their
obligations under the terms of our collaboration agreements and
generate sales related to our technologies; the success of our
efforts to enter into new strategic partnerships and advance our
programs, including, without limitation, in North America, Europe
and Japan; our possible inability to execute our strategy due to
changes in our industry or the economy generally; changes in
productivity and reliability of suppliers; and the success of our
competitors and the emergence of new competitors. You should not
place undue reliance on forward-looking statements contained in
this press release, 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/20200415005210/en/
Ivor Macleod Chief Financial Officer Tel: (216) 431-9900
ir@athersys.com
Karen Hunady Director of Corporate Communications & Investor
Relations Tel: (216) 431-9900 khunady@athersys.com
David Schull Russo Partners, LLC Tel: (212) 845-4271 or (858)
717-2310 David.schull@russopartnersllc.com
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