Asterias Scores FDA Orphan Status for AST-OPC1

Fremont, Calif.-based Asterias Biotherapeutics announced good news last week, with the FDA granting orphan drug designation to AST-OPC1, the company’s candidate for acute spinal cord injury.

As a result, Asterias can receive a number of benefits, including potential marketing exclusivity, tax credits and a waiver of certain administrative fees.

AST-OPC1 has been shown in animals or in vitro to have three potentially reparative functions, including the production of neurotrophic factors, stimulation of vascularization and induction of remyelination of denuded axons.