Athersys (ATHX) Receives FDA’s Special Protocol Assessment for Phase 3 Study of MultiStem® Treatment
Athersys (NASDAQ: ATHX) has received an 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 the company’s novel MultiStem® cell therapy product for the treatment of ischemic stroke. Per the SPA agreement, 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. “This is a major accomplishment for Athersys, as it clearly defines the development and…







