Athersys Inc (NASDAQ:ATHX) reported that its associate, HEALIOS K.K. has registered the first patient in its trial in Japan assessing MultiStem® cell therapy cure of patients who have faced an ischemic stroke. Named as the Treasure study, it is intended to enroll as many as 220 subjects with moderate to severe strokes.
The Treasure study will be randomized 1:1, with subjects getting a single intravenous infusion of placebo or MultiStem within 18 to 36 hours at the start of the stroke. The main efficacy result is the proportion of subjects getting an Excellent Outcome at 3-months post treatment. Excellent Outcome is a generally used degree of efficacy in stroke treatment, assessed utilizing three usual clinical rating scales of neurological and functional deficit and recovery after the stroke, including modified Rankin Scale, Barthel Index and the NIH Stroke Scale.
Dr. Gil Van Bokkelen, the Chairman and CEO of Athersys, reported that they are delighted that the TREASURE trial in Japan is now registering patients. With a successful study outcome, Japan’s progressive regulatory guideline for regenerative medicine offerings provides the prospect for either full marketing or conditional approval. In addition, the priority review status received under the Sakigake framework is intended to boost the review by the Pharmaceutical & Medical Devices Agency of Japan, allowing development of this program in an extremely efficient manner.
Dr. Van Bokkelen added that this is the leading stem cell study commenced under the latest regenerative medicine regulatory structure established in Japan, and it exhibits a vital milestone. They believe that MultiStem possesses the potential to meaningfully improve recovery after a stroke and considerably extend the treatment window from numerous hours under prevailing standard of care, which is just pertinent to a small percentage of stroke people, out to 36 hours, allowing treatment of a larger number of people.