- Last 365-day patient follow-up visit was completed on
schedule for the Phase 2/3 TREASURE study for ischemic
stroke
- Topline results expected to be
announced in May
Athersys, Inc. (Nasdaq: ATHX) announced today that its partner,
HEALIOS K.K. (Healios), has provided updates on its two clinical
programs evaluating MultiStem® (invimestrocel, HLCM051) cell
therapy, for which Healios has a license and is responsible for the
development and commercialization of MultiStem for ischemic stroke
and acute respiratory distress syndrome (ARDS) in Japan on an
exclusive basis.
Healios reported that the last patient in its Phase 2/3 TREASURE
study, evaluating MultiStem for the treatment of ischemic stroke,
completed the 365-day follow-up visit. Additionally, Healios
updated its progress in its discussions with the Pharmaceuticals
and Medical Devices Agency (PMDA) regarding its MultiStem ARDS
program and results from its ONE-BRIDGE study.
The last patient follow-up visit represents an important
milestone in the TREASURE study, as it completes the collection of
all patient data and enables the final validation of the data,
analyses, and preparation of results by its contract research
organization for unblinding and topline disclosures. Healios
anticipates that it will receive the final topline results and make
disclosures in May 2022.
TREASURE is a randomized, double-blind, placebo-controlled study
in Japan evaluating the administration of MultiStem treatment
within 18-36 hours after an ischemic stroke in over 200 patients
with moderate to moderate-severe strokes. The TREASURE study, like
its global counterpart, Athersys’ MASTERS-2 study, was designed
based on the promising results from Athersys’ MASTERS-1 study for
stroke patients treated with MultiStem therapy within 36 hours of
the stroke. In the MASTERS-1 study, stroke patients receiving early
MultiStem treatment had better outcomes than placebo patients at 90
days following treatment, and further improved outcomes at one
year. Athersys expects that the TREASURE 90-day and one-year
results would be strong indicators of the potential results from
Athersys’ MASTERS-2 study.
“We are happy to report that Healios has completed the last
patient follow-up visit and will soon disclose topline results from
this important study,” commented Dr. John Harrington, Chief
Scientific Officer of Athersys. “Furthermore, we are optimistic
about the results and look forward to evaluating the data and
better understanding its implications for our MASTERS-2 study.”
In addition, Healios has announced feedback received from the
PMDA after recent consultation meetings to obtain guidance and
advice pertaining to its application for MultiStem approval for
ARDS, an orphan regenerative medicine program, on the basis of its
Phase 2 ONE-BRIDGE study. The ONE-BRIDGE clinical trial was
designed as a 30-patient, open label study, and demonstrated
promising impact from MultiStem treatment on ventilator free days
(VFD) and mortality. While the PMDA did not disagree with the
efficacy and safety conclusions of the ONE-BRIDGE study, the PMDA
advised Healios that additional supporting data is necessary for
application for approval of MultiStem treatment for the ARDS
indication. As a result of the guidance from the PMDA, Healios does
not currently plan to apply for approval in Q2 2022. Healios will
continue discussions with PMDA and work toward early application,
and while it is undetermined at this time, it is expected that the
application for approval is unlikely to take place in the current
fiscal year.
Athersys is currently conducting its Phase 2/3 MACOVIA study,
evaluating MultiStem treatment for ARDS patients, which includes
patients diagnosed with ARDS due to COVID-19. The Company recently
announced FDA approval to use product manufactured with its next
generation bioreactor-based platform in the MACOVIA study.
Athersys continues to believe that MultiStem treatment has
potential to have a substantial, positive impact on ARDS patients
based on favorable data from its own double-blind,
placebo-controlled Phase 1/2 MUST-ARDS study and strong supporting
data from the Healios ONE-BRIDGE study. For example, on a combined
basis, MultiStem-treated subjects had, on average, 5.5 more VFD in
the first 28-days following diagnosis than non-treated subjects
(with a p-value = 0.07) and, on a median basis, 10.5 more VFD
during the 28-day period. Further, there was also strong evidence
of a favorable impact from treatment on mortality and quality of
life metrics. Athersys plans to work closely with Healios to build
the supporting data necessary to apply for approval in Japan,
including exploring the possibility of using certain MACOVIA
clinical data.
“We congratulate Healios for achieving this important milestone
in the TREASURE study and look forward to the topline results in
May,” said Mr. Dan Camardo, Chief Executive Officer of Athersys.
“We also look forward to continuing our work with Healios to
advance the ARDS program in Japan. This is a very exciting time for
both companies, and we remain committed to our partnership with
Healios to work toward bringing MultiStem to market in Japan and
eventually to the U.S. and other regions.”
Please refer to the following Healios disclosures for more
information:
https://ssl4.eir-parts.net/doc/4593/tdnet/2103272/00.pdf and
https://ssl4.eir-parts.net/doc/4593/tdnet/2103271/00.pdf
About Ischemic Stroke
Stroke represents an area where the clinical need is
particularly significant, since it is a leading cause of death and
serious disability worldwide, with a substantially impaired quality
of life for many stroke victims. Currently, there are nearly 17
million people who suffer a stroke globally and more than two
million stroke victims each year in the United States, Europe and
Japan, combined. Ischemic strokes, which represent the most common
form of stroke, are caused by a blockage of blood flow in the brain
that cuts off the supply of oxygen and nutrients and can result in
long-term or permanent disability due to neurological damage.
Unfortunately, current therapeutic options for ischemic stroke
victims are limited, since the only available treatments,
administration of the clot dissolving agent tPA, or “thrombolytic,”
or surgical intervention to remove the clot, must be conducted
within several hours of the occurrence of the stroke. As a
consequence of this limited time window, only a small percentage of
stroke victims are treated with the currently available
therapy—most simply receive supportive or “palliative” care. The
long-term costs of stroke are substantial, with many patients
requiring extended hospitalization, extended physical therapy or
rehabilitation (for those patients that are capable of entering
such programs), and many require long-term institutional or family
care.
About ARDS
Acute respiratory distress syndrome (ARDS) is a serious
immunological and inflammatory condition characterized by
widespread inflammation in the lungs. ARDS can be triggered by
COVID-19, pneumonia, sepsis, trauma or other events and represents
a major cause of morbidity and mortality in the critical care
setting. It has significant implications, as it prolongs intensive
care unit (ICU) and hospital stays and requires convalescence in
the hospital and rehabilitation. There are limited interventions
and no effective drug treatments for ARDS, making it an area of
high unmet clinical need with high treatment costs. Given these
high treatment costs, a successful cell therapy could be expected
to generate significant savings for the healthcare system by
reducing days on a ventilator and in the ICU and importantly, could
reduce mortality and improve quality of life for those suffering
from the condition.
About MultiStem®
MultiStem® cell therapy (invimestrocel) 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 outcome
data, its novel mechanisms of action, and favorable and consistent
tolerability data in clinical studies, we believe that MultiStem
therapy may 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 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 Healios
Healios is Japan’s leading clinical stage biotechnology company
harnessing the potential of stem cells for regenerative medicine.
It aims to offer new therapies for patients suffering from diseases
without effective treatment options. Healios is a pioneer in the
development of regenerative medicines in Japan, where it has
established a proprietary, gene-edited “universal donor” induced
pluripotent stem cell (iPSC) line to develop next generation
regenerative treatments in immuno-oncology, ophthalmology, liver
diseases, and other areas of severe unmet medical need. Healios’
lead iPSC-derived cell therapy candidate, HLCN061, is a next
generation NK cell treatment for solid tumors that has been
functionally enhanced through gene-editing. Its near-term pipeline
includes the somatic stem cell product HLCM051 (MultiStem®), which
is currently being evaluated in Japan in Phase 2/3 and Phase 2
trials in ischemic stroke and acute respiratory distress syndrome
(ARDS), respectively. Healios was established in 2011 and has been
listed on the Tokyo Stock Exchange since 2015 (TSE Growth: 4593).
https://www.healios.co.jp/en.
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. Some of the more significant known risks that
we face 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. 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, including but not limited to, our
ability to access our traditional financing sources and to continue
as a going concern; 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, and the Healios TREASURE clinical trial in Japan
evaluating the treatment in stroke, including the timing of the
release of data by Healios from its clinical trials; theability of
Healios to apply for approval for MultiStem for the treatment of
ARDS in Japan, which could be delayed by, among other things, the
regulatory process with the PMDA; the success of our MACOVIA
clinical trial evaluating the administration of MultiStem for the
treatment of COVID-19 induced ARDS, 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 impact of the COVID-19 pandemic on our
ability to complete planned or ongoing clinical trials; the
possibility that the COVID-19 pandemic could delay clinical site
initiation, clinical trial enrollment, regulatory review and the
potential receipt of regulatory approvals, payment of milestones
under our license agreements and commercialization of one or more
of our product candidates, if approved; the availability of product
sufficient to meet commercial demand shortly following any
approval, such as in the case of accelerated approval for the
treatment of COVID-19 induced ARDS; 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 or globally;
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 impact of the COVID-19 pandemic on the production capabilities
of our contract manufacturing partners and our MultiStem trial
supply chain; 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 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 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; 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; 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. Although we
currently believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee our
future results, levels of activity or performance. We undertake no
obligation to publicly update forward-looking statements, whether
as a result of new information, future events or otherwise, except
as otherwise required by law. You are advised, however, to consult
any further disclosures we make on related subjects in our reports
on Forms 10-Q, 8-K and 10-K furnished to the SEC. You should
understand that it is not possible to predict or identify all risk
factors. Consequently, you should not consider any such list to be
a complete set of all potential risks or uncertainties.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220404005390/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
Peter Vozzo ICR Westwicke Tel: (443) 213-0505
peter.vozzo@westwicke.com
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