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CLEVELAND, Oct. 2, 2012 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) recently completed enrollment of the first patient cohorts of its Phase 2 study of MultiStem
®, a novel adult stem cell therapy being developed by Athersys, administered to patients within approximately 1 to 2 days after they have experienced an ischemic stroke. The independent safety committee reviewed data from these patients, finding that both of the doses evaluated were safe and well tolerated, and therefore, recommended proceeding with high dose administration to patients for the remainder of the trial.
The Phase 2 study is a double blind, placebo-controlled trial evaluating the safety and efficacy of MultiStem when administered to patients who have suffered a moderate to moderately severe stroke, as defined by a National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20. Patients enrolled in the study receive a single intravenous dose of MultiStem therapy or placebo in the 24 to 36 hours following the stroke, which is a significant extension of the current treatment window over existing standard of care. The study is currently being conducted at multiple centers throughout the United States.
"We are very excited about the initial results from this program and believe that it could represent a major advance in clinical care for ischemic stroke patients. We believe MultiStem has the potential to significantly enhance patient recovery, as well as meaningfully extend the treatment window over the current standard of care for stroke victims, enabling many more patients to receive treatment," said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys. "We are pleased with the results from the initial phase of the study, including the additional evidence of a consistent safety profile for MultiStem, and we intend to move the program forward aggressively to completion."
The first part of the Phase 2 study included two cohorts, with each cohort including a placebo group and a treatment group – a low dose of MultiStem in the first cohort and a higher dose in the second cohort. The third cohort has a placebo group and treatment group, randomized 1 to 1. The study is expected to enroll approximately 136 patients in total.