Progress on all fronts
Recently, Athersys reported progress with both US and Japanese regulatory authorities. The company reached a deal with the FDA for the design of its pivotal Phase III trial for MultiStem in ischemic stroke under a Special Protocol Assessment (SPA) and should be able to file with just one 300-patient Phase III trial run in North America and Europe. Other clinical data, including the results of its trial in Japan (the design of which has just been accepted by the PMDA), will be used to support the NDA.Athersys is a biotechnology company that is focused in the field of regenerative medicine. The company's MultiStem? cell therapy, a patented and proprietary allogeneic stem cell product, is its primary platform product and is in clinical development. The company's existing clinical development programs are focused on treating neurological conditions, cardiovascular disease, inflammatory and immune disorders, certain pulmonary conditions and other conditions where the existing standard of care is limited or inadequate for a number of patients. The company has a collaboration with HEALIOS K.K., to develop and commercialize MultiStem for the treatment of certain indications in Japan.
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