FDA approves Athersys' Multistem Phase 3 trial

The U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), has agreed to Athersys' design and analysis of a Multistem Phase 3 study.

Multistem is Athersys' cell therapy product designed to treat of ischemic stroke.

“This is a major accomplishment for Athersys, as it clearly defines the development and regulatory pathway for the approval of MultiStem cell therapy for the treatment of ischemic stroke,” Athersys Chairman and CEO Dr. Gil Van Bokkelen said. “We would like to thank the FDA for its engagement and guidance in this process, and the clinical investigators who have been critical to our development of this potential treatment for stroke.

"The SPA is important in clarifying and de-risking an accelerated development pathway for us because it means that the successful completion of the MASTERS-2 trial, together with other available clinical data, could enable us to apply for marketing approval in the United States. With this goal now achieved, we will continue the process of engagement with the FDA, European and Canadian regulators, as well as the many sites, to complete other necessary activities prior to trial initiation."

Athersys intends to be prepared to launch the trial in 2017.