Neurological (Stroke Phase II)
Our clinical focus in the neurological area involves evaluating the efficacy of MultiStem® cell therapy to treat ischemic stroke. In 2016, we completed a Phase 2 study of MultiStem cell therapy to treat patients suffering a moderate to severe ischemic stroke and announced the positive one-year follow-up data and final results from the study at the International Stroke Conference. Since that time, we have been actively preparing for the next stage of clinical development of this program, both independently and with our collaborative partner in Japan, HEALIOS K.K. (Healios), and have made several important announcements.
In the fall of 2016, we announced agreement from the FDA under a Special Protocol Assessment (SPA) for the design and planned analysis of a pivotal Phase 3 clinical trial (referred to as MASTERS-2) for ischemic stroke. The SPA provides formal agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support a regulatory submission for marketing approval, if the trial is successful. Results from the MASTERS-2 trial, together with other available clinical data, would provide th...