BioTime Unit Gets FDA Nod To Initiate Phase 1/2a Clinical Trial Of AST-OPC1

By RTT News, August 27, 2014, 09:14:00 AM EDT

(RTTNews.com) - BioTime, Inc. ( BTX ) Wednesday said its subsidiary Asterias Biotherapeutics, Inc. ( ASTY ) has received clearance from the U.S. Food and Drug Administration 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. It 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.

ST-OPC1 is a population of cells derived from human embryonic stem cells that contains oligodendrocyte progenitor cells or OPCs.

There are currently no approved therapies for the treatment of spinal cord injury.

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BioTime Unit Gets FDA Nod To Initiate Phase 1/2a Clinical Trial Of AST-OPC1