Enrollment completed in second cohort of
MATRICS-1 trial in hemorrhagic trauma Enrollment reaches
halfway mark in MASTERS-2 trial in ischemic stroke
Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine company
developing MultiStem® (invimestrocel) for critical care
indications, today provided an update on ongoing clinical trials
with MultiStem for the treatment of patients following hemorrhagic
trauma (MATRICS-1) and for the treatment of ischemic stroke
(MASTERS-2). MultiStem is a proprietary off-the-shelf stem cell
product in late-stage clinical trials for acute ischemic stroke, as
well as trauma and other inflammatory conditions.
MATRICS-1 is an investigator-initiated Phase 1/2 randomized,
double-blind, placebo-controlled trial evaluating MultiStem in
patients following resuscitation from hemorrhagic trauma that is
underway at the University of Texas-Houston and the Memorial
Hermann Hospital, the busiest Level 1 Trauma Center in the U.S.
Athersys announces that complete enrollment has been reached in the
second cohort in which patients were dosed with MultiStem cells
manufactured under Athersys’ new 3D manufacturing process. This
will provide Athersys with safety data for 3D-treated patients and
comparability against 2D-treated patients in the first cohort. This
trial aims to enroll 156 patients in total, and enrollment in the
third and final cohort is expected to begin later in 2023. This
trial is being supported in part by MTEC (Medical Technology
Enterprise Consortium) in partnership with the Department of
Defense.
MASTERS-2 is a company-sponsored Phase 3 randomized,
double-blind, placebo-controlled trial evaluating MultiStem for the
treatment of acute ischemic stroke. Athersys announces that more
than half of the 300 expected patients have now been enrolled in
this multinational, multicenter trial. The rate of patient
enrollment significantly increased during 2022 due in part to the
opening of new sites across more geographies. More sites are
expected to be activated throughout 2023.
“We are pleased to report these enrollment updates as they
demonstrate both increasing interest in MultiStem and improved
execution by our team and our partners. We’ve been able to
significantly accelerate patient enrollment in MASTERS-2 due to
more effective site management, enhanced clinician confidence based
on TREASURE results and the opening of more sites. Athersys’
enthusiasm about MultiStem for the treatment of ischemic stroke has
been bolstered by results from completed clinical trials, and we
look forward to providing updates on MASTERS-2 after we engage with
regulatory authorities during the first quarter of 2023,” stated
Dan Camardo, Chief Executive Officer of Athersys.
MultiStem cells deliver benefit through distinct 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. Data in
multiple animal models of acute neurological injury led to the
development of this hypothesis regarding the cell mediated
mechanism of action and is supported by 2 human clinical trials
evaluating the MultiStem cell product following acute ischemic
stroke that leads to increased recovery benefit over time.
“Cell therapy is among the most promising treatment paradigms
for neurological and other disorders. MultiStem’s unique mechanism
may shift the treatment of stroke by expressing a range of
therapeutically relevant proteins and other factors to deliver
multiple clinical benefits, including reducing inflammation,
protecting damaged or injured tissue, and enhancing the formation
of new blood vessels in regions of ischemic injury. By considering
the effects of secondary immune modulation, therapeutic benefit may
be better observed over longer periods of time versus current
commercial treatments like tPA,” stated Sean I. Savitz, M.D.,
Director at World Stroke Organization and Frank M. Yatsu, M.D.
Chair in Neurology at UTHealth Houston’s McGovern Medical
School.
In November 2022, Athersys convened a meeting of stroke Key
Opinion Leaders (KOLs) to discuss potential changes to the
MASTERS-2 trial design, given clinical findings from Healios’
TREASURE trial in Japan as well as from the MASTERS-1 study.
Following input from these KOLs, Athersys is considering possible
protocol adjustments in support of the overall goal of de-risking
the program, while also reflecting evolving best standard-of-care.
Because any protocol changes would need to be submitted to the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) prior to being implemented, it is premature to discuss
what, if any, modifications might be made.
“Clinical results to date – including those from TREASURE and
MASTERS-1 – demonstrate success that meets or even exceeds the
efficacy that tPA delivers to stroke patients after 90 days when
administered within approximately 30 minutes of the ischemic event.
I believe that MultiStem holds potential to be a significant
advancement in the treatment of stroke with longer-term patient
benefits by providing a solution as impactful as tPA while
significantly extending the treatment window. In fact, I see strong
parallels between tPA treatment results in the 1990s and MultiStem
today,” stated David Chiu, M.D., FAHA, Professor, Elizabeth Blanton
Wareing Chair in the Eddy Scurlock Stroke Center, Houston Methodist
Hospital, Weill Cornell Medical College and a participant on the
Athersys KOL panel.
“Following productive discussions during our recent meeting with
stroke KOLs, the totality of data from MASTERS-1 and TREASURE gives
us confidence that MultiStem progressively improves patient
outcomes, with emerging evidence of meaningful benefit 365 days
post-treatment. We intend to share these data with the FDA and EMA
later this quarter to evaluate the design of the MASTERS-2 trial
and ensure it supports this hypothesis,” stated Willie Mays, Ph.D.,
Executive Vice President and Head of Regenerative Medicine and
Neuroscience Programs at Athersys.
Providing further support for the clinical potential of cell
therapy, a recently published review article1 lead-authored by Dr.
Savitz in Nature Reviews Neurology synthesized results from more
than 20 years of animal studies that illustrate how
trans-differentiation, cell replacement and restoration of damaged
tissues in the central nervous system are highly unlikely
mechanisms. The authors consider the evidence for an alternative
model in which exogenous cells migrate to peripheral organs and
modulate and reprogram host immune cells to generate an
anti-inflammatory regenerative environment.
The authors state, “Regenerating tissue by modulating
inflammatory and repair mechanisms is widely applicable to a range
of neurological disorders, from acute to neuro-degenerative
disorders, autoimmune and inflammatory diseases and chronic
neurological disorders.”
Commenting on an announcement made last month by Healios,
Athersys’ MultiStem partner in Japan, Mr. Camardo added, “We are
encouraged by Healios’ recent letter of intent to establish a new
company for the joint development of MultiStem for acute
respiratory distress syndrome, or ARDS, with investment from
Mitsubishi UFJ Capital. We believe their partnership demonstrates
continued momentum in clinical development and reflects the growing
interest from larger companies in MultiStem.”
Athersys management will be in San Francisco during the 41st
J.P. Morgan Healthcare Conference January 9-11, 2023 meeting with
investors, analysts and prospective business partners. Please email
tpatel@lhai.com to request a meeting.
______________ 1 Cell-based therapies for neurological disorders
— the bioreactor hypothesis
https://www.nature.com/articles/s41582-022-00736-4
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 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,
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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
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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
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publicly update forward-looking statements, whether as a result of
new information, future events or otherwise.
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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,
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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 collaborators’ ability and
willingness to continue to fulfill their obligations under the
terms of our collaboration agreements and generate sales related to
our technologies; 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: whether the FDA and the EMA
accept any protocol changes to our MASTERS-2 trial design and the
timing of such acceptance, if at all; 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 requirement; 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230109005293/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
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