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Asterias Biotherapeutics Granted Orphan Drug Designation for AST-OPC1 for the Treatment of Acute Spinal Cord Injury

Vivien Diniz
Feb. 04, 2016 08:57AM PST
Biotech Investing

Asterias Biotherapeutics, Inc. (NYSE MKT:AST) has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its product development candidate, AST-OPC1, for the treatment of acute spinal cord injury.

Asterias Biotherapeutics, Inc. (NYSE MKT:AST) has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its product development candidate, AST-OPC1, for the treatment of acute spinal cord injury.
According to the press release:

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals or in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hind limb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

Click here to view the full press release.

in vitro orphan drug designation asterias biotherapeutics orphan drug food and drug administration stem cells
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