February 23, 2017

Overview of MultiStem® Clinical Trial in Japan Presentation at International Stroke Conference 2017

Details of Healios' Phase II/III trial (HLCM051) being presented by stroke expert and lead investigator Dr. Kyohiro Houkin

CLEVELAND, Feb. 23, 2017 (GLOBE NEWSWIRE) -- 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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Source: Athersys, Inc.

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