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CLEVELAND, Sept. 28, 2016 – Athersys, Inc. (NASDAQ:ATHX) announced today that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys' novel MultiStem® cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys' planned Phase 3 study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase 3 trial entitled, "MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2" (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.

CLEVELAND February 17, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced positive results from the analysis of one-year follow-up data from its Phase 2 clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who have suffered an ischemic stroke. Dr. David Hess, lead clinical investigator of this study and a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia, Augusta University, presented the summary results today at the 2016 International Stroke Conference in Los Angeles. The one-year data demonstrates that MultiStem-treated subjects on average continued to improve through one year and had a significantly higher rate of "Excellent Outcome" (defined clinically as attaining mRS 0-1, NIHSS 0-1 and BI ≥95) compared to placebo subjects at one year when evaluating all subjects enrolled in the study (p=0.02), i.e., the intent-to-treat population. The relative improvement in Excellent Outcomes was even more pronounced in the patients who received MultiStem treatment within 36 hours of the stroke (p < 0.01).

CLEVELAND and TOKYO, Jan. 08, 2016 – Healios K.K. ("Healios") (Tokyo Stock Exchange:4593) and Athersys, Inc. ("Athersys") (NASDAQ:ATHX) have announced a partnership and license agreement that will focus on the development and commercialization of novel cell therapy treatments, including MultiStem® for the treatment of ischemic stroke and potentially other indications, in Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf stem cell therapy being developed by Athersys, with an initial focus on treating ischemic stroke.

Regenerative Medicine Partnership Focused on Development of Novel Stem Cell Therapy
CLEVELAND and TOKYO, March 2, 2015 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) and Chugai Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4519) have announced a partnership and license agreement to exclusively develop and commercialize MultiStem® cell therapy for ischemic stroke in Japan. Ischemic stroke represents a priority disease area in Japan, given the high healthcare burden of the condition and the expected increase in incidence associated with Japan's aging population.

Innovate UK Grant Awarded for MultiStem(R) Therapy Clinical Trial in United Kingdom
LONDON and CLEVELAND, Jan. 22, 2015 (GLOBE NEWSWIRE) -- 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.

Top-Line Data Readout Expected Around the End of the First Quarter, 2015

CLEVELAND, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys' MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015.