Athersys, Inc. (Nasdaq: ATHX) announced today that its clinical
program evaluating MultiStem® cell therapy for the treatment of
Acute Respiratory Distress Syndrome (“ARDS”) has received Fast
Track designation from the United States Food and Drug
Administration (“FDA”). This important designation is given to
qualified investigational therapies that show promise in providing
benefit to patients in areas of significant unmet medical need.
Fast Track designation allows for an expedited regulatory review
process after the clinical data is submitted to help speed
development of promising therapies to the market in order to help
patients in areas where current standard of care is limited.
In January 2019, the Company announced favorable
top-line results from a randomized, double-blind placebo-controlled
exploratory Phase 2 clinical study evaluating MultiStem
administration to patients with ARDS, referred to as the MUST-ARDS
study. ARDS is a serious and life-threatening pulmonary
condition that requires patients to be placed on a ventilator in
the intensive care unit (“ICU”) and is associated with a high level
of mortality. Many patients that do survive face extended stays in
the ICU and experience difficult and challenging recoveries. In the
MUST-ARDS study, patients who received MultiStem treatment within
several days after being diagnosed with ARDS and being placed on a
ventilator experienced lower mortality, increased ventilator-free
days, and increased ICU-free days during the initial 28-day
clinical assessment period relative to patients receiving
placebo. Additional data from the trial will be presented on
May 20, 2019 at the annual American Thoracic Society meeting.
The Company’s collaborator in Japan, HEALIOS K.K., has initiated
and is enrolling patients in its clinical trial evaluating
administration of MultiStem to pneumonia-induced ARDS patients in
Japan.
In addition to the ARDS Fast Track announcement,
Athersys is hosting an Investor Day event today for shareholders,
potential investors, analysts and other invited guests to highlight
the Company’s capabilities, technologies, research programs,
clinical trials and plans. A summary video from the
Investor Day event will be available on the Company’s website
approximately one week after the event.
“We are honored to have received Fast Track designation from the
FDA for our ARDS program, which supports the promise of our cell
therapy for treating patients in an area where new and more
effective treatments are needed. This designation complements
other indications where we have received important regulatory
designations, including Fast Track and RMAT designations for our
ongoing Phase 3 program for ischemic stroke,” commented Dr. Gil Van
Bokkelen, Chairman and CEO, at Athersys. “We share the same
priorities and goals as the FDA, including putting patient safety
and well-being first and foremost, and a desire to see safe and
effective new therapies developed in areas where standard of care
is limited or simply unavailable for many patients.
“Our Investor Day event will highlight some of the exciting
progress we are making in several key areas, and will provide an
opportunity for clinical experts, patient advocates, and others to
share their perspective alongside members of the Athersys
leadership team, and we are truly grateful for the many expressions
of support that we have received,” concluded Dr. Gil Van
Bokkelen.
Also, on May 20, 2019, Dr. Geoff Bellingan, Medical Director at
University College London Hospitals, will be presenting additional
data from the exploratory Phase 1/2 ARDS study, (“MUST-ARDS”) at
the American Thoracic Society International Conference in Dallas,
Texas. Dr. Bellingan’s talk is titled, “Primary Analysis of a
Phase 1/2 Study to Assess MultiStem® Cell Therapy, a Regenerative
Advanced Therapy Medicinal Product (ATMP), in Acute Respiratory
Distress Syndrome (MUST-ARDS)”.
About Fast Track Designation
Fast Track is a process designed by the FDA to facilitate the
development and expedite the review of drugs that have the
potential to treat serious conditions and address recognized areas
of unmet medical need. The purpose is to help speed development of
new drugs that are evaluated to be safe and effective, making them
available to the patient earlier. For more information on the Fast
Track process, please
visit:https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
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. It has significant implications, as it prolongs 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 approximately 400,000 -
500,000 patients in Europe, the United States and Japan
annually.
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 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 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
Officer
Tel: (216)
431-9900
bjlehmann@athersys.com
Karen Hunady Director of Corporate Communications and Investor
RelationsTel: (216) 431-9900khunady@athersys.com
David
Schull
Russo Partners, LLCTel: (212) 845-4271 or (858)
717-2310David.schull@russopartnersllc.com
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