First Patient In Japan Enrolled In Test Of Treatment For Ischemic Stroke.
The study is will enroll 220 patients with moderate to severe strokes and will be randomized 1:1, with patients receiving a single intravenous infusion of MultiStem or placebo within 18 to 36 hours of the onset of the stroke.
The primary efficacy outcome is the proportion of subjects achieving an Excellent Outcome at three months following treatment.
Excellent Outcome is a commonly used measure of efficacy in stroke treatment, evaluated using three standard clinical rating scales of functional and neurological deficit and recovery following the stroke, including the NIH Stroke Scale, modified Rankin Scale and Barthel Index.
In parallel with the TREASURE trial, Athersys has been planning for its Phase 3 study entitled, MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2 (MASTERS-2), to be conducted in North America and Europe.
The FDA has authorized the MASTERS-2 study under a Special Protocol Assessment (SPA) for the design and planned analysis of this pivotal clinical trial.
The SPA provides formal agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses in this Phase 3 study are acceptable to support a regulatory submission for marketing approval of MultiStem cell therapy as a product for treating ischemic stroke patients.
The FDA also awarded the MultiStem stroke program Fast Track designation, making it eligible for accelerated approval, priority review and rolling submission of the biologics license application, which facilitates a timely regulatory review.
The MASTERS-2 trial also obtained a Final Scientific Advice positive opinion from the European Medicines Agency, and received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which was established this year under the 21st Century Cures Legislation.
The RMAT designation may be obtained for eligible cell therapy and other regenerative medicine and advanced therapies when the FDA agrees that preliminary clinical evidence indicates that the therapy has demonstrated the potential to address unmet medical needs for a serious or life-threatening disease or condition.
The designation enables sponsors to discuss with the FDA multidisciplinary strategic development plans, including expediting manufacturing development plans for commercialization to support priority review and accelerated approval.
Stroke represents an area where the clinical need is particularly significant, since it is a leading cause of death and serious disability worldwide, with a substantially impaired quality of life for many stroke victims. Nearly 17 million people suffer a stroke globally and more than two million each year in the United States, Europe and Japan.
MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage.
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|Publication:||Stem Cell Business News|
|Date:||Nov 27, 2017|
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