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 regulatory pathway for the approval of MultiStem cell therapy for the treatment of ischemic stroke,” Dr. Gil Van Bokkelen, chairman and CEO of Athersys, stated in the news release.
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Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com
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