The first patient has been enrolled in a Phase III study -MASTERS-2- to evaluate MultiStem cell therapy treatment of patients who have suffered an ischemic stroke.- Athersys, Inc.

Athersys, Inc. announced that the first patient has been enrolled its Phase III study entitled, MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2 (�MASTERS-2�) to evaluate MultiStem cell therapy treatment of patients who have suffered an ischemic stroke.

The MASTERS-2 clinical trial is a randomized, double-blind, placebo-controlled clinical trial designed to enroll 300 patients in North America and Europe who have suffered moderate to moderate-severe ischemic stroke. The enrolled subjects will receive either a single intravenous dose of MultiStem cell therapy or placebo, administered within 18 to 36 hours of the occurrence of the stroke, in addition to the standard of care. The primary endpoint will evaluate disability using modified Rankin Scale (mRS) scores at three months, comparing the distribution, or the �shift,� between the MultiStem treatment and placebo groups. The mRS shift analysis considers disability across the full spectrum, enabling recognition of large and small improvements in disability and differences in mortality and other serious outcomes, among strokes of different severities. The study will also assess Excellent Outcome (mRS ?1, NIHSS ?1, and Barthel Index ?95) at three months and one year as key secondary endpoints. Additionally, the study will consider other measures of functional recovery, biomarker data and clinical outcomes, including hospitalization, mortality, life-threatening adverse events and post-stroke complications, such as infection.

Comment: The MASTERS-2 study has received authorization from the FDA under a Special Protocol Assessment for the design and planned analysis of th e Phase III pivotal clinical trial and Fast Track designation and also obtained a Final Scientific Advice positive opinion from the European Medicines Agency and received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which was established under the 21st Century Cures Legislation.