Athersys Limited (an affiliate of Athersys, Inc.) (Nasdaq:ATHX) and
the Cell Therapy Catapult, a not-for-profit centre, which is
focused on the development of the United Kingdom cell therapy
industry to increase the nation's health and wealth, are pleased to
announce that Athersys Limited has been awarded a grant from
Innovate UK, formerly the Technology Strategy Board, which will
support a Phase 2a clinical study evaluating the administration of
MultiStem® cell therapy to acute respiratory distress syndrome
(ARDS) patients.
The grant is expected to provide up to approximately £2.0
million in support over the course of the study, which will be
conducted by Athersys Limited at leading clinical sites in the UK
in conjunction with the Cell Therapy Catapult.
"We are pleased to receive this award from Innovate UK and to
work with the Cell Therapy Catapult to conduct this important
study. Both organizations reflect a commitment to be a driving
force in healthcare innovation, and to establish the UK as the
leading gateway for the regenerative medicine field in Europe,"
said Dr. Gil Van Bokkelen, Chairman and CEO of Athersys,
Inc. "ARDS is a serious condition that is ineffectively
treated by current standards of care, resulting in substantial
patient and healthcare system impact. We believe that MultiStem
cell therapy may provide an important new option for treatment, and
has the potential to meaningfully improve clinical outcomes for
patients that are extremely ill."
Keith Thompson, CEO of the Cell Therapy Catapult said, "We are
excited by the potential health benefits this trial may achieve for
such severe and life-threatening disease, such as
ARDS. Bringing advanced therapeutic clinical trials to the UK
is a key part of our strategy to accelerate the growth of the cell
therapy industry to generate health and wealth. We are delighted to
collaborate with Athersys Limited on this important trial."
ARDS is a serious immunological and inflammatory condition
characterised by widespread inflammation in the lungs. ARDS can be
triggered by pneumonia, sepsis, or other trauma 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, days in the ICU and total days in
the hospital, 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 33,000 patients in the UK and 400,000 - 500,000
patients in Europe, the United States and Japan, alone.
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. In animal models, MultiStem cells have
demonstrated an ability to reduce the severity of pulmonary
distress, reduce alveolar edema and return lung endothelial
permeablity to normal. Intravenous MultiStem treatment early
following the onset of the condition may ameliorate the initial
hyper-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 Athersys
Athersys is a clinical stage 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 platform
for disease indications in the cardiovascular, neurological,
inflammatory and immune disease areas. The Company currently has
several clinical stage programs involving MultiStem, including for
treating ischemic stroke, inflammatory bowel disease, damage caused
by myocardial infarction, and for the prevention of
graft-versus-host disease. Athersys has also developed a diverse
portfolio that includes other technologies and product development
opportunities, and has forged strategic partnerships and
collaborations with leading pharmaceutical and biotechnology
companies, as well as world-renowned research institutions to
further develop its platform and products. Athersys Limited
conducts operations and clinical development on behalf of Athersys
in the United Kingdom, Europe and beyond.
About the Cell Therapy Catapult
The Cell Therapy Catapult is a centre of translational
excellence for cell therapy and regenerative medicine. Its vision
is for the UK to be a global leader in the development, delivery
and commercialisation of cell therapy, making it a location for
business start-up and growth. Based in London at Guy's
Hospital, the centre takes products into early clinical trials,
providing clinical, technical, manufacturing, regulatory, health
economics and market access expertise. There is a focus
on collaboration and lowering barriers to investment and funding,
and operations have grown rapidly since inception. UK Trade &
Investment has valued the global regenerative medicine industry at
just over £500 million, and estimates that it will be generating
revenues of over £5 billion by 2021. For more information go to
ct.catapult.org.uk
About Catapults
Catapult centres are being established and overseen by Innovate
UK as a new addition to its range of programmes to stimulate
innovation. They are places where the best of the UK's innovative
businesses and researchers work together to bring new products and
services more quickly to commercialisation. Focusing on areas with
great market potential, Catapults will open up global opportunities
for the UK and generate economic growth for the future. For more
information, please visit www.catapult.org.uk
About Innovate UK
Innovate UK is the new name for the Technology Strategy Board –
the UK's innovation agency. Taking a new idea to market is a
challenge. Innovate UK funds, supports and connects innovative
businesses through a unique mix of people and programmes to
accelerate sustainable economic growth. For further information
visit www.innovateuk.org
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 human therapeutics, such as the
uncertainty regarding market acceptance of our product candidates
and our ability to generate revenues, including MultiStem for the
treatment of acute respiratory distress syndrome and other disease
indications. 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 additional
capital; final results from our MultiStem clinical trials; the
possibility of delays in, adverse results of, and excessive costs
of the development process; our ability to successfully initiate
and complete clinical trials; changes in external market factors;
changes in our industry's overall performance; changes in our
business strategy; our ability to protect our intellectual property
portfolio; our possible inability to realize commercially valuable
discoveries in our collaborations with pharmaceutical and other
biotechnology companies; our collaborators' ability to continue to
fulfill their obligations under the terms of our collaboration
agreements; the success of our efforts to enter into new strategic
partnerships and advance our programs; 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: Athersys Limited
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel-UK: 0131-516-3002
Tel-USA: (216) 431-9900
bjlehmann@athersysltd.co.uk
bjlehmann@athersys.com
Cell Therapy Catapult
David Robertson
Head of Communications
Tel: 0203-728-9675
david.robertson@ct.catapult.org.uk
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