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December 23, 2015

Sunovion begins stroke study recruitment

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Sunovion Pharmaceuticals of Marlborough has begun inpatient recruitment for a clinical trial to test proprietary cell therapy that could benefit stroke victims.

This is Phase 2b of the clinical trial, which will be pursued in partnership with SanBio, Inc. Results from an earlier clinical trial suggest the therapy has potential to improve motor function following an ischemic stroke, according to Sunovian. Ischemic strokes account for approximately 87 percent of all strokes in the United States and occur when there is an obstruction in a blood vessel supplying oxygen to the brain. With approximately 800,000 strokes occurring in the United States every year, stroke is the leading cause of acquired disability for Americans.

This trial will examine the safety and efficacy of SB623 cells in patients who have experienced an ischemic stroke in the previous six months to five years and still suffer from motor impairments, Sunovian said in a release. When administered into neural tissue, SB623 cell therapy is designed to promote recovery from injury by triggering the brain’s natural regenerative ability.

The ACTIsSIMA Phase 2b clinical trial follows a Phase 1/2a clinical trial in which the SB623 cell treatment suggested improvements in motor function. The Phase 2b clinical trial will further evaluate the safety and efficacy of SB623 treatment. There are expected to be approximately 60 clinical trial sites throughout the United States, and total enrollment is expected to reach 156 patients.

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