Athersys, Inc. (Nasdaq: ATHX) announced today that its partner,
HEALIOS K.K. (“Healios”), has enrolled the first patient in its
ONE-BRIDGE study in Japan, evaluating MultiStem® cell therapy
treatment of patients who suffer from acute respiratory distress
syndrome (“ARDS”). The clinical trial investigates the efficacy and
safety of MultiStem therapy for patients with pneumonia-induced
ARDS. This trial will enroll 30 patients with 20 subjects receiving
the cell therapy treatment and standard of care and 10 subjects
receiving standard therapy alone. The primary endpoint will be the
number of ventilator-free days – the days in which the patient was
not on a ventilator in the 28 days following the treatment.
In June 2018, Healios entered into an agreement
with Athersys to expand its collaboration into additional
therapeutic areas. Under the terms of the agreements, among other
things, Healios obtained an exclusive license for the development
and commercialization in Japan of MultiStem therapy for the
treatment of ARDS.
In January 2019, Athersys announced positive
results from its exploratory Phase 1/2 ARDS clinical study. The
results further confirmed the tolerability and safety of the cell
therapy and demonstrated the potential for benefits in mortality,
ventilator-free days and ICU-free days. The Athersys trial results
will be presented at the upcoming 2019 ATS International
Conference, scheduled on May 20th in Dallas.
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
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 ARDS 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.
The medical need for a safe and effective treatment of ARDS is
significant due to its high mortality rate, and it affects annually
approximately 400,000 - 500,000 patients in Europe, the United
States and Japan.
MultiStem cell therapy has demonstrated the
capacity to reduce inflammation, support tissue regeneration and
promote homeostasis in acute immunological and injury settings.
Preclinical data suggests that MultiStem cells may have a
protective effect by shifting the physiological response from
pro-inflammatory to anti-inflammatory, and through the promotion of
key reparative mechanisms. In animal models, MultiStem cells have
demonstrated an ability to reduce inflammation, reduce fluid
retention in the lungs and return lung function to normal.
Intravenous MultiStem treatment early following the onset of ARDS
may ameliorate the initial inflammation and reduce the fibrotic
activity that follows, thereby speeding the return to and improving
the likelihood of more normal lung function and helping patient
recovery.
About MultiStem
MultiStem 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
produced 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 safety
profile demonstrated in clinical studies, 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 an international 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,
cardiovascular, and inflammatory and immune disease areas, 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.
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: our ability to raise capital to fund our operations; the
timing and nature of results from our MultiStem clinical trials,
including the MASTERS-2 Phase 3 clinical trial and the Healios’
TREASURE clinical trial in Japan; 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 to us,
such as due to material supply constraints, contaminations, 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
stroke, acute respiratory distress syndrome, 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 work with Healios to
reach an agreement for an option in China; 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.
Contacts:
William (B.J.) Lehmann, J.D.President and Chief
Operating OfficerTel: (216) 431-9900 bjlehmann@athersys.com
Karen HunadyDirector of Corporate Communications
and Investor RelationsTel: (216) 431-9900khunady@athersys.com
David SchullRusso Partners, LLCTel: (212)
845-4271 or (858) 717-2310David.schull@russopartnersllc.com
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