BioTime Subsidiary Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients With Cervical Complete Spinal Cord Injury
Dose Escalation Clinical Trial to Test Initial Safety and Activity of AST-OPC1 in Patient Population with the First Indication Targeted for Product Registration ----- FDA Clearance Triggers Definitive Contract Finalization with California Institute of Regenerative Medicine (CIRM) to Begin $14.3 Million in Trial Funding
ALAMEDA, Calif.-- BioTime, Inc. (NYSE MKT:BTX) announced that its subsidiary Asterias Biotherapeutics, Inc. (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.
- Published: 27 August 2014
- Written by Editor