Update: On track for a big Japanese trial
Athersys and its Japanese development partner Healios are on track to begin a 150-200 patient registration trial for MultiStem in stroke in Japan. We expect the company to file an IND with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in mid-summer and begin enrolling patients in Q416. Importantly, a successful trial of this size could enable them to gain full approval in Japan instead of conditional approval and could potentially be used as part of a registration package in the US.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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