Athersys, Inc. (Nasdaq:ATHX) announced today a presentation
featuring its MultiStem® cell therapy treatment for ischemic stroke
at the International Stroke Conference 2017 this week in Houston.
Dr. Kiyohiro Houkin, Professor and Chairman at Department of
Neurosurgery of Hokkaido University Graduate School of Medicine,
and Director of Hokkaido University Hospital, will present an
overview of the Treatment Evaluation of Acute Stroke Using
Regenerative Cell Elements (TREASURE) study, which is the Phase
II/III trial of MultiStem (HLCM051) being conducted by HEALIOS K.K.
in Japan.
Athersys and Healios entered into a license
agreement in January 2016 and have been collaborating on the
development and commercialization of MultiStem for the treatment of
stroke in Japan. Athersys completed a Phase II clinical study
(MASTERS-1) of its proprietary MultiStem cell therapy for the
treatment of ischemic stroke and is currently preparing for a
registrational Phase III study that will be conducted in the U.S.,
Europe and Canada.
Dr. Houkin’s presentation entitled, Treatment
Evaluation of Acute Stroke Using Regenerative Cell Elements
(TREASURE): A Randomized Controlled Phase II/III Trial of MultiStem
(HLCM051), will take place during the session beginning at 6:15 PM
CST today at the George R. Brown Convention Center, Hall E.
“We are very excited to be commencing this
clinical trial at Hokkaido University Hospital and then at other
leading stroke centers across Japan,” said Dr. Houkin. “The need
for safe, effective and clinically-practical treatments for
ischemic stroke patients has never been greater. Based on the
clinical results from the recently completed MASTERS-1 Phase II
clinical study, many believe that innovative treatments like
MultiStem cell therapy hold great promise for treating the
devastating effects of a stroke and helping patients recover more
effectively. Given the rapidly expanding aging population both in
Japan and globally, safe and effective treatments that can reach a
greater number of stroke victims could make a significant
difference for many patients and their families.”
In conjunction with the ISC 2017 conference, Athersys also
announced an informational video featuring former NFL player and
stroke survivor Tedy Bruschi. Available for viewing at
https://www.youtube.com/user/AllianceRegenMed, the video focuses on
the potential of increasing the post-ischemic stroke treatment
window while chronicling the challenges facing doctors with today’s
limited options. CBS broadcaster Solomon Wilcots moderates the
video that includes stories of both Bruschi and a Houston stroke
survivor who participated in the MASTERS-1 study.
About the Conference
The International Stroke Conference is the
world’s premier meeting dedicated to the science and treatment of
cerebrovascular disease. Clinical Sessions focus on community risk
factors; emergency care; acute neuroimaging; acute endovascular and
acute nonendovascular treatment; diagnosis of stroke etiology;
cerebral large artery disease; in-hospital treatment; clinical
rehabilitation and recovery; and health services, quality
improvement, and patient-centered outcomes. Basic Science Sessions
focus on vascular biology in health and disease; basic and
preclinical neuroscience of stroke recovery; and experimental
mechanisms and models. Further specialized topics include pediatric
stroke; intracerebral hemorrhage; nursing; preventive strategies;
vascular cognitive impairment; aneurysms; subarachnoid hemorrhage;
neurocritical care; vascular malformations; and ongoing clinical
trials.
Presentations on these topics attract a wide
range of healthcare professionals and investigators including adult
and pediatric neurologists; neurosurgeons; neuroradiologists and
interventional radiologists; physiatrists; emergency medicine
specialists; primary care physicians; hospitalists; nurses and
nurse practitioners; rehabilitation specialists; physical,
occupational, and speech therapists; pharmacists; and basic
researchers spanning the fields of cerebrovascular function and
disease.
About MultiStem
MultiStem cell therapy is a patented
regenerative medicine product 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 product 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 both preclinical and clinical settings, MultiStem
therapy could provide a meaningful benefit to patients, including
those suffering from serious diseases and conditions with unmet
medical need. Athersys has forged strategic partnerships and a
broad network of collaborations to develop MultiStem cell therapy
for a variety of indications, with an initial focus in the
neurological, cardiovascular and inflammatory and immune disorder
areas.
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, inflammatory and immune disease areas, and has
several ongoing clinical trials evaluating this potential
regenerative medicine product. Athersys 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. 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
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 ischemic stroke,
acute myocardial infarction, spinal cord injury and acute
respiratory distress syndrome and other disease indications,
including graft-versus-host disease. 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 collaboration with Healios and others, including our ability to
reach milestones and receive milestone payments, and whether any
products are successfully developed and sold so that we earn
royalty payments; 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 or collaborations and advance our
programs; our ability to raise additional capital; results from our
MultiStem ongoing and planned 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 within the
expected time frame or at all; 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 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.
ATHX-STR
Contact:
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
David Schull
Russo Partners, LLC
12 West 27th Street, 4th Floor
New York, NY 10001
Tel: (212) 845-4271
David.schull@russopartnersllc.com
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