(MENAFN- ProactiveInvestors - N.America) Shares in Athersys (NASDAQ:ATHX) gained on Wednesday after it announced that it had received a Special Protocol Agreement (SPA) from the US Food and Drug Administration (FDA) for its planned Phase III trial of its MultiStem stroke treatment.
The SPA is a declaration from the FDA that Athersys' Phase III trial's design, clinical endpoints and statistical analyses for MultiStem are acceptable for FDA approval.
"This is a major accomplishment forAthersys, as it clearly defines the development and regulatory pathway for the approval of MultiStem cell therapy for the treatment of ischemic stroke," stated chairman and chief executive Gil Van Bokkelen.
A SPA allows companies to run their trials without fear that the FDA will reject the design itself should they subsequently apply for approval following a successful outcome.
With the SPA, a successful trial would now provide the foundation of the regulatory package to be submitted for marketing approval.
Stroke affects more than 17mln people around the world each year, and is a leading cause of death and disability.
Athersys claims MultiStem has shown the ability to promote tissue repair and healing in a variety of ways, and says it could have a 'meaningful benefit' for stroke patients.
Shares were up 9% to US$2.13.
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.