BioTime (BTX) Subsidiary Asterias Biotherapeutics Receives FDA Clearance To Initiate Phase 1/2a Clinical Trial Of AST-OPC1 In Patients With Cervical Complete Spinal Cord Injury
8/27/2014 10:56:06 AM
ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE MKT:BTX) announced that its subsidiary Asterias Biotherapeutics, Inc. (OTCBB:ASTY) has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury. The approved trial follows the successful completion of the Phase 1 clinical study of the product, and is designed to assess safety and activity of escalating doses of AST-OPC1 in patients with complete cervical spinal cord injuries, the first targeted indication for AST-OPC1 and the first of future product registration clinical trials.
“We would like to acknowledge the scientists, clinical investigators, and FDA for working with us to develop AST-OPC1,” stated Pedro Lichtinger, President and CEO of Asterias. “We are especially enthusiastic about working with our new partner, CIRM, in executing this clinical trial. The FDA clearance provides Asterias with imminent access to the previously announced $14.3 million CIRM grant, which provides non-dilutive funding to support both the clinical trial and other product development activities for AST-OPC1.”
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