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Asterias Biotherapeutics (NYSEMKT: AST) starts enrollment and dosing for a P1/2a study in complete cervical spinal cord injury.

July 12, 2016 9:45am

The SCiSTAR study is being funded in part by a $14.3 M grant from the California Institute of Regenerative Medicine (CIRM).

SCiSTAR study is a P1/2a clinical trial evaluating activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI).

In this cohort, five patients (constituting the minimum number required to complete the cohort) were each administered 10 million AST-OPC1 cells.

AST recently received clearance from the U.S. FDA to expand enrollment in the study, including up to three additional patients into this 10 million cell cohort for a total of eight patients.

The Bottom Line: This is the second of three cohorts in the study and it represents the first cohort in which patients have been administered a dose high enough to fall within the potentially efficacious range predicted from extensive preclinical studies. AST expects to report top-line six-month efficacy and safety results from this five patient cohort in January 2017.

NYSEMKT: AST opened UP +$0.04 at the open

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