Athersys, Inc. (NASDAQ: ATHX) announced today the one-year
follow-up summary results from its exploratory clinical study of
the intravenous administration of MultiStem® cell therapy to treat
patients who are suffering from acute respiratory distress syndrome
(ARDS). Participants in the MUST-ARDS study were evaluated through
28 days for the primary clinical assessment and further assessed
through a one-year follow-up period. The one-year results were
consistent with the positive day-28 results announced last year,
and an evaluation of quality-of-life over the one-year period
suggests further potential benefits from MultiStem treatment.
Highlights from the new and previously disclosed
data include:
- Previously observed lower mortality
for MultiStem-treated subjects compared to placebo (particularly
among the prospectively defined subset of more severe ARDS
patients) persisted out to one-year of follow-up;
- Day-365 Quality of Life (QoL) outcomes, assessed by the EQ-5D,
were meaningfully better among all survivors who received MultiStem
treatment compared to those who received placebo;
- Within the prospectively defined
group of patients with more severe ARDS, MultiStem treatment was
associated with a markedly greater rate of survival and progression
to functional independence at one year (i.e., self-care);
- As measured at day-28, MultiStem
treatment was associated with a higher mean ventilator-free day
(VFD) score of 12.9 vs. 9.2 in the placebo group, and a higher mean
intensive care unit (ICU)-free day score of 10.3 vs. 8.1 in the
placebo group;
- As measured at day-28, among more
severe ARDS patients, mean VFD in the MultiStem subgroup was 14.6
vs. 8.0 in placebo subgroup. Mean ICU-free days were 11.4 vs. 5.9
for MultiStem and placebo recipients, respectively;
- Lower inflammatory cytokine levels
at day-7 in the MultiStem group relative to the placebo group,
including IFNg, IL-6 and IL-1b among others, suggest the potential
for MultiStem treatment to abate the severe inflammatory response
associated with ARDS; and
- MultiStem treatment was well
tolerated in this very sick ARDS patient population, with no
serious adverse events related to administration through one year
of follow-up.
“We believe that the more favorable outcomes, as
reflected in the patient reported self-assessments, particularly
among patients recovering from more severe ARDS, suggest that
administration of MultiStem has the potential to meaningfully
enhance the ability of these patients to reestablish functional
independence and restore quality of life,” noted Dr. Anthony Ting,
Vice President of Regenerative Medicine and Head of Cardiopulmonary
Programs at Athersys. “Frequently, ARDS patients have a very
challenging road to recovery, suffering depression or decreased
physical abilities. Many are unable to return to work or engage in
other activities. The prospect of being able to help many patients
overcome these difficulties is very exciting, and we look forward
to publishing these results.”
The MUST-ARDS study was designed to evaluate the
impact of MultiStem treatment in subjects with acute onset of
moderate to severe ARDS and was conducted at sites in the United
States and United Kingdom. Treatment was required to begin within
four days of ARDS diagnosis with an average treatment time of
approximately two days from the diagnosis. In the Phase 2a portion
of the study, 20 subjects were treated with an intravenous
administration of 900 million MultiStem cells and 10 subjects
received placebo; the study was not powered for the efficacy
outcomes. Based on the study results, the Company is planning
further development in this area and intends to submit for
publication the detailed study data.
About ARDS
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. ARDS is associated with a high mortality
rate and significant sequelae among survivors. The condition
prolongs ICU and hospital stays and often requires extended
convalescence in the hospital and rehabilitation care settings.
There are limited interventions and no effective drug treatments
for ARDS. There is a large unmet need for a safe treatment that can
reduced mortality and improve quality of life for those suffering
with ARDS. Additionally, given the high treatment costs associated
with ARDS, a successful therapy could be expected to generate
significant savings for the healthcare system by reducing days on a
ventilator and in the ICU.
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 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 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: 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 Healios’
TREASURE and ONE-BRIDGE clinical trials 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
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.
Contact:
William (B.J.) LehmannPresident and Chief
Operating Officer Tel: (216)
431-9900bjlehmann@athersys.com
Karen Hunady Director of Corporate
Communications & Investor RelationsTel: (216)
431-9900khunady@athersys.com
David SchullRusso Partners, LLCTel: (212)
845-4271 or (858) 717-2310David.schull@russopartnersllc.com
Athersys (NASDAQ:ATHX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Athersys (NASDAQ:ATHX)
Historical Stock Chart
From Sep 2023 to Sep 2024