Athersys, Inc. (Nasdaq: ATHX) announces today results of a
radiation countermeasure study conducted by the Armed Forces
Radiobiology Research Institute (AFRRI), a Department of Defense
research laboratory under the leadership of the Uniformed Services
University of the Health Sciences, that showed intravenous
MultiStem® (invimestrocel) administration provided benefit in an
animal model of acute radiation syndrome (ARS). The results
demonstrate that the administration of MultiStem cells increased
survival in treated animals compared to vehicle treatment (p=0.03),
resulted in higher body weights in surviving animals and positive
trends in recovery of the hematopoietic system.
“This program represents another positive step in a broader
development strategy to investigate the use of MultiStem in
addressing severe critical care injuries and diseases,” commented
Mr. Dan Camardo, Chief Executive Officer of Athersys.
Athersys has conducted research relevant to ARS over several
years. Its initial research focused on hematopoietic stem cell
transplant (HSCT) and graft versus host disease (GvHD) areas,
including a clinical study demonstrating that MultiStem treatment
has the potential to improve survival and neutrophil and platelet
recovery and reduce GvHD in HSCT patients. Athersys also completed
pilot work on ARS undertaken in collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID) and the Armed
Forces Radiobiology Research Institute (AFRRI).
In general, this research has demonstrated the potential for
MultiStem treatment to improve survival and recovery following
radiation injury. The recent countermeasure study builds on this
foundation. In summary, 25 mice received two doses of MultiStem
cells and 25 received two doses of vehicle, administered
intravenously. Survival was evaluated at day 30 from irradiation,
with 84% survival of MultiStem-treated rodents compared to 52%
survival of vehicle-treated animals (p=0.03). Additionally, body
weight was significantly different between the groups (p<0.01) –
higher in the MultiStem group – reflecting reduced weight loss
associated with the acute injury and/or accelerated recovery.
Further, there were trends towards increased megakaryocytes and
bone marrow colony forming units in surviving animals at day
60.
“We are very enthusiastic about the results from this radiation
countermeasure study conducted by AFRRI,” commented Dr. Robert W.
Mays, Executive Vice President and Head of Regenerative Medicine
& Neuroscience Programs of Athersys. “Based on this study and
prior research, we believe that MultiStem therapy has the potential
to provide benefit to victims of ARS as well as other immune and
neurological disorders. We look forward to exploring opportunities
to move this important program forward.”
This study is one of several preclinical programs that will be
the focus of an upcoming webinar hosted by the Regenerative
Medicine team at Athersys titled, Rebalancing the Immune System:
The MultiStem® Cellular Platform for Treating Disease and
Injury. Preclinical research using MultiStem cells has shown
Multipotent Adult Progenitor Cells, or MAPC®, may be beneficial in
the treatment of a variety of critical care and difficult to treat
inflammatory diseases. On Monday, August 29, 2022, Dr. Robert W.
Mays and Dr. Sarah Busch, Vice President, Regenerative Medicine
& Head of Nonclinical Development, will be hosting a webinar to
provide a comprehensive update on the Company’s preclinical
programs.
Date
August 29, 2022
Time
4:00 p.m. (Eastern Time)
Live webcast registration
Webcast link
About Acute Radiation Syndrome
Acute Radiation Syndrome, or ARS, is an acute condition
resulting from irradiation of the body by a high dose of
penetrating radiation over a short period of time. ARS may be
associated with destructive and irreparable changes in the bone
marrow and gastrointestinal (GI) tract, resulting in infection,
hemorrhage and dehydration. The condition may also lead to edema,
vasculitis and failure of the cardiovascular and central nervous
systems. Examples of ARS victims include survivors of the Hiroshima
and Nagasaki atomic bombs and the first responders to the 1986
Chernobyl nuclear power plant event. The Syndrome develops in
stages as a function of the dose received. At lower doses a period
of bone marrow damage lasting weeks which ultimately can be lethal
without intervention is expected. At higher doses of radiation, the
GI tract would be impacted immediately to shortly after exposure,
followed by a period of bone marrow damage lasting weeks, then a
period of severe symptoms and illness including further GI
involvement, infection and hemorrhage, and then recovery or death
depending on the exposure levels and bone marrow recovery.
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.
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.
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, statements regarding the
potential benefits of our MultiStem product candidate; anticipated
results of clinical trials involving our MultiStem product
candidate; 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. 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: 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 raise
capital to fund our operations in the near term, including, but not
limited to, our ability to raise financing and to continue as a
going concern; our ability to enter into a partnership for the
co-development and co-commercialization of MultiStem; our ability
to successfully implement our transformation plan, including our
ability to reduce expenses; 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 filings 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.
Disclaimers
The opinions and assertions expressed herein are those of the
author(s) and do not reflect the official policy or position of the
Uniformed Services University of the Health Sciences or the
Department of Defense. For the contributors from AFRRI, neither
they nor their family members have a financial interest in any
commercial product, service, or organization providing financial
support for this research.
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version on businesswire.com: https://www.businesswire.com/news/home/20220808005430/en/
Ellen Gurley Manager of Corporate Communications and
Investor Relations egurley@athersys.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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