News | Stroke | July 12, 2017

SanBio Receives $20 Million Grant for Stroke Clinical Trial

ACTIsSIMA trial will assess safety and efficacy of stem cell product in patients with chronic motor impairments resulting from ischemic stroke

SanBio Receives $20 Million Grant for Stroke Clinical Trial

July 12, 2017 — SanBio Inc. recently announced it has been awarded a $20 million grant from the California Institute of Regenerative Medicine (CIRM) in support of its Phase 2b clinical trial for the treatment of chronic stroke (ACTIsSIMA), jointly sponsored with Sunovion Pharmaceuticals Inc.

CIRM is an agency of the State of California formed to accelerate the progress of regenerative medicine through a highly competitive grant program. Prospective grants are evaluated by an independent panel of the nation's top experts in regenerative medicine, as well as medical authorities on neurological disorders. The evaluation of this stroke program received CIRM's highest ranking of 1.

Stroke is the leading cause of acquired disability in the United States. Many patients suffer from permanent loss of function. After the first six months, the possibility for further recovery through traditional therapies is minimal. Sufferers from stroke disability impose a significant burden on the health care system.

“Today the CIRM Board approved two very different methods, using different kinds of stem cells, to address this need,” said Maria Millan, M.D., interim CEO and president of the agency. “By funding multiple shots on goal we believe that we have a better chance of finding a way to repair the damage caused by stroke and give people a better quality of life.”

The ACTIsSIMA (Allogeneic Cell Therapy for Ischemic Stroke to Improve Motor Abilities) clinical trial studies the safety and efficacy of SanBio’s proprietary cell-based product, SB623, in patients with chronic motor impairments resulting from ischemic stroke. Enrollment for the ACTIsSIMA study is expected to be complete in March 2018. Patients will be monitored for 12 months, with results reported in 2019. This trial follows its Phase 1/2a study, the results of which were reported in the journal Stroke last year.1

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