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Athersys’ MultiStem® Data to be Presented at International Stroke Conference 2016
Globe Newswire
Multiple Presentations by Leading Stroke Clinical Investigators

CLEVELAND, Feb. 10, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today that six presentations featuring Athersys’ MultiStem® cell therapy treatment for ischemic stroke will be made at the 2016 International Stroke Conference hosted by the American Heart Association, to be held February 17-19, 2016 at the Los Angeles Convention Center, located at 120 South Figueroa Street, Los Angeles, CA.  Athersys has recently completed a Phase 2 clinical study of its proprietary cell therapy for the treatment of ischemic stroke and is planning for the next phase of clinical development.  A collaboration with Athersys and HEALIOS K.K. was recently announced to develop and commercialize MultiStem for the treatment of stroke in Japan.

The presentations will be made by several of Athersys’ clinical collaborators and experts in the field, as follows:

 DateTime (PST) Presenter Topic Room
February 17 (Session 109)8:45 amDr. David Hess,
One, Two, Three Steps toward Cell Therapy for Stroke, and in the Future (Debate)Room 151
February 171:30 pmDr. David HessFinal Results of the B01-02 Phase 2 Trial testing the Safety and Efficacy of MultiStem in Treatment of Ischemic StrokeRoom 502 B
February 182:18 pmDr. Lawrence WechslerMultiStem Treatment Reduces Length of Hospitalization When Administered Within 36 Hours After Onset of Ischemic Stroke:  Implications On Lowering Stroke Related Health Care CostsRoom 408
February 186:15 pmDr. Sean SavitzAcute Intravenous MultiStem Infusion Restores Hemeostasis of Immune and Spleen Responses After Ischemic StrokeHall H
February 197:12 amDr. Wayne ClarkExploratory Results From the B01-02 Trial:  Administration of MultiStem Results in Decreased Circulating CD3+ Cells and Lower Levels of Inflammatory CytokinesRoom 152
February 19 (Session 41)9:23 amDr. David HessSafety and Efficacy of IV Stem Cell Therapy in Acute Stroke:  What is the Evidence from the MultiStem Trial?Room 515 B

Dr. David Hess is a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia Regents University, and served as the lead principal investigator in the MultiStem stroke study. Dr. Lawrence R. Wechsler, Henry B. Higman Professor of Neurology/Neurosurgery and Chair, Department of Neurology, University of Pittsburgh Medical Center, and Dr. Wayne M. Clark, Director of the Oregon Health and Science University Stroke Center, were also clinical investigators in the MultiStem study.  Dr. Sean I. Savitz, Director, Vascular Neurology Program & Fellowship at the University of Texas Medical School and members of his team will present additional pre-clinical data about the mechanism of action of MultiStem in a poster session.

“The B01-02 clinical trial represents the largest randomized clinical study of intravenous cell therapy to date. I am encouraged that the treatment with MultiStem was well tolerated and safe, and that there was reduction in life threatening adverse events, infections and mortality among subjects receiving cell therapy, in comparison to placebo. Overall, we did not find significant evidence of efficacy when looking at patients treated within a 24 to 48 hour window; however, it was encouraging that we observed benefit when MultiStem was administered within 36 hours of the stroke, consistent with the initial study design,” commented Dr. Hess.  “In the one year follow up results that will be presented, we are particularly interested in evaluating the proportion of subjects that achieve an Excellent Outcome, as reflected by excellent improvement in each of the three clinical rating scales used.  Such an outcome reflects the ability to recapture a high quality of life and live independently, and is what patients, families, clinicians and healthcare providers care most about.”

About the Conference

The International Stroke Conference is the world’s largest meeting dedicated to the science and treatment of cerebrovascular disease. The conference features more than 1,500 presentations that emphasize basic, clinical and translational sciences, as they evolve toward a more complete understanding of stroke pathophysiology with the overall goal of developing more effective prevention and treatment. Sessions in clinical categories will center on stroke community risk factors, emergency care, acute neuroimaging, endovascular and nonendovascular treatment, diagnosis, cerebrovascular occlusive disease, in-hospital treatment, and outcomes of stroke. Sessions in basic science categories focus on vascular biology in health and disease, experimental mechanisms and models, and basic and translational neuroscience of stroke recovery. Further specialized topics include rehabilitation and recovery, pediatric stroke, intracerebral hemorrhage, nursing, preventive strategies, vascular cognitive impairment, aneurysm, subarachnoid hemorrhage and other neurocritical management, vascular malformations, and ongoing clinical trials. Cutting-edge presentations on these topics attract a wide range of healthcare professionals and investigators 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 cardiovascular, neurological, 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.

William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900

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