University Hospitals Cleveland Medical
Center, a nationally ranked hospital, is ready to start screening
patients
Athersys, Inc. (NASDAQ: ATHX) and University Hospitals Cleveland
Medical Center (UH Cleveland) announced today that UH Cleveland is
now open as the first clinical site for the MACOVIA (MultiStem®
Administration for COVID-19 Induced Acute Respiratory Distress
Syndrome) trial.
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On April 13, 2020, Athersys announced authorization from the
U.S. Food and Drug Administration (FDA) to begin the MACOVIA study
and began the process of clinical site initiation. UH Cleveland has
completed trial start-up activities enabling commencement of
patient screening and enrollment in this important randomized,
double-blind, placebo-controlled study.
Dr. Frank Jacono, MD, Associate Professor of Medicine and
Pulmonary and Critical Care Medicine Physician at UH Cleveland and
Cleveland VA Medical Center will serve as principal investigator.
UH Cleveland is now screening COVID-19 induced ARDS patients for
inclusion in the trial.
Acute respiratory distress syndrome (ARDS) is the leading cause
of death among COVID-19 infected patients, according to the World
Health Organization and other recent clinical and epidemiological
data. With the spread of COVID-19, there is an immediate need for
therapies for the treatment of ARDS. The MACOVIA trial aims to
confirm the safety and efficacy of MultiStem therapy as a treatment
for patients with moderate to severe ARDS due to COVID-19.
UH Cleveland is a leading pulmonary critical care center in the
United States and participated in Athersys’ completed Phase 1/2
MUST-ARDS study. The data from the MUST-ARDS study met its primary
endpoint of tolerability, and study subjects receiving MultiStem
experienced less mortality, more ventilator-free days and more
intensive care unit (ICU)-free days during the 28-day clinical
evaluation period than the subjects who received placebo. Based on
this promising data, the FDA granted Fast Track designation to the
Company’s ARDS program.
“Progressing from an FDA authorization to a site activation in
just a few weeks is a tremendous achievement,” commented Dr.
Anthony Ting, PhD, Vice President of Regenerative Medicine and Head
of Cardiopulmonary Programs at Athersys. “This was only possible
due to the diligent effort performed by UH Cleveland and its
dedicated staff.
“Based on our prior clinical results, we are optimistic that
MultiStem may be able to provide meaningful therapeutic benefits to
critically ill patients with COVID-19 induced ARDS,” concluded Dr.
Ting.
The primary efficacy endpoint for the MACOVIA study will be
number of ventilator-free days through day 28 as compared to
placebo, and the secondary objectives are to evaluate clinical
parameters (e.g., time in the intensive care unit), pulmonary
function, all-cause mortality, tolerability and quality of life
(QoL) among survivors. The study is designed to enroll
approximately 400 subjects and will be conducted at leading
pulmonary critical care centers throughout the United States.
MultiStem therapy’s potential for multidimensional therapeutic
impact may distinguish it from traditional biopharmaceutical
therapies focused on a single mechanism of benefit. Since MultiStem
is not virus- or pathogen-specific, it may have the potential to
treat ARDS that develops from a variety of causes, including
COVID-19, as well as other pathogen-induced or non-infectious
causes of severe lung inflammation leading to ARDS.
The Company is in discussions with the Biomedical Advanced
Research and Development Authority (BARDA) to advance the
development of MultiStem to treat patients with ARDS resulting from
the COVID-19 epidemic and other potential pandemic outbreaks.
For more detailed information on the Company’s ARDS program,
please visit the ARDS page on the Athersys website.
ARDS
ARDS is a serious respiratory 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 long-term
complications and disability among survivors. 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 reduce mortality and improve Quality of Life
(QoL) for those surviving ARDS. Additionally, given the high
healthcare resource burden associated with treatment of ARDS
patients, a successful therapy could be expected to generate
significant savings for the healthcare system by reducing days on a
ventilator and in the ICU, or in the setting of a widespread high
pathogenicity respiratory virus pandemic, make those resources more
rapidly available to other patients.
About COVID-19
COVID-19 is the infectious disease caused by the most recently
discovered human coronavirus, SARS-CoV-2. This new disease was
unknown before the outbreak was first discovered in Wuhan, China,
in December 2019. Older people and those with underlying medical
problems such as high blood pressure, heart problems or diabetes,
are more likely to develop serious illness, but even young,
previously healthy people can suffer severe disease and
complications such as ARDS. Data are still emerging, but recently
published case series suggest mortality rates among COVID-19
patients who develop ARDS may be 50% to 70%, or perhaps even higher
in some environments.
About MultiStem®
MultiStem® cell therapy 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 efficacy data, its novel mechanisms of action, and
favorable and consistent tolerability data 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 University Hospitals
Founded in 1866, University Hospitals serves the needs of
patients through an integrated network of 18 hospitals, more than
50 health centers and outpatient facilities, and 200 physician
offices in 16 counties throughout northern Ohio. The system’s
flagship academic medical center, University Hospitals Cleveland
Medical Center, located in Cleveland’s University Circle, is
affiliated with Case Western Reserve University School of Medicine.
The main campus also includes University Hospitals Rainbow Babies
& Children's Hospital, ranked among the top children’s
hospitals in the nation; University Hospitals MacDonald Women's
Hospital, Ohio's only hospital for women; University Hospitals
Harrington Heart & Vascular Institute, a high-volume national
referral center for complex cardiovascular procedures; and
University Hospitals Seidman Cancer Center, part of the
NCI-designated Case Comprehensive Cancer Center. UH is home to some
of the most prestigious clinical and research programs in the
nation, including cancer, pediatrics, women's health, orthopedics,
radiology, neuroscience, cardiology and cardiovascular surgery,
digestive health, transplantation, and urology. UH Cleveland
Medical Center is perennially among the highest performers in
national ranking surveys, including “America’s Best Hospitals” from
U.S. News & World Report. UH is also home to Harrington
Discovery Institute at University Hospitals – part of The
Harrington Project for Discovery & Development. UH is one of
the largest employers in Northeast Ohio with 28,000 physicians and
employees. Advancing the Science of Health and the Art of
Compassion is UH’s vision for benefitting its patients into the
future, and the organization’s unwavering mission is To Heal. To
Teach. To Discover. Follow UH on LinkedIn, Facebook
@UniversityHospitals and Twitter @UHhospitals. For more
information, visit UHhospitals.org.
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: the success of
our MACOVIA study; our ability to raise capital to fund our
operations; our ability to successfully finalize and implement an
alliance with BARDA, and the terms of any such alliance, including
the amount, if any, of funding that we might receive; the timing
and nature of results from MultiStem clinical trials, including our
MASTERS-2 Phase 3 clinical trial and the HEALIOS K.K. (Healios)
TREASURE and ONE-BRIDGE clinical trials in Japan; 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;
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 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 ischemic stroke, ARDS, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200501005131/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
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