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Asterias Biotherapeutics (NYSEMKT: AST) Cleared to begin highest dosing in AST-OPC1 Study

August 31, 2016 8:52am

Patients in third cohort will get highest dose of 20m cells, P1/2a study is also enrolling first cohort of sensory incomplete cervical spinal cord injury patients (AIS-B), who will get 10m cells

AST’s data monitoring committee reviewed safety data from first two cohorts and cleared company to begin dosing third cohort of 5-8 patients with complete cervical injury (AIS-A patients) in “SCiStar” study.

The Bottom Line: Asterias previously announced that it had been granted FDA clearance to expand patient enrollment in the P1/2a clinical trial from 13 patients to up to 35 patients, based on the continued favorable safety profile observed in the ongoing clinical study.

AST believes that this change will increase the statistical confidence of the safety and efficacy readouts – to reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 M of non-dilutive funding for the P1/2a clinical trial and other product development activities for AST-OPC1.

AST closed at $2.74 and is UP incrementally +$0.01 in the pre-open.

It's a BUY

More than 17,000 people sustain a spinal cord injury each year, but there are no FDA-approved therapeutics or devices that could potentially restore some function in individuals who have recently sustained a spinal cord injury.

35 companies, 1 interpreter!

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