Asterias Biotherapeutics doses first spinal cord injury patient with AST-OPC1 20m cells cohort in SCiStar clinical trial.
M2 EQUITYBITES-November 9, 2016-Asterias Biotherapeutics doses first spinal cord injury patient with AST-OPC1 20m cells cohort in SCiStar clinical trial
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Biotechnology company Asterias Biotherapeutics (NYSE MKT:AST) said on Tuesday that it is evaluating the first patient with complete (AIS-A) cervical spinal cord injury with the highest dose of 20m cells of AST-OPC1 (oligodendrocyte progenitor cells) under its SCiStar clinical trial at Santa Clara Valley Medical Center (SCVMC) in San Jose, CA.
In conjunction, the company said it has dosed the second patient in the AIS-B 10m cell cohort.
This open-label, single-arm SCiStar trial is testing three sequential escalating doses of AST-OPC1 administered at up to 20m AST-OPC1 cells in 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.The study is being conducted at six centre in the US and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrolment.
AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury, stated the company.
The company added that the dose escalation to 20m cells followed the Data Monitoring Committee (DMC) review of safety data from the prior 2m cell and 10m cell dose cohorts and was based on AST-OPC1's continued favorable safety profile observed in the ongoing clinical study.
Recently, the company has presented positive early efficacy data from the 10m cell cohort. These data reached the six month efficacy target within three months and suggested the emergence of a possible early dose response for AST-OPC1. The trial results to date continue to support a positive safety profile for AST-OPC1.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Nov 9, 2016|
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