Asterias Biotherapeutics, Inc. (NYSE MKT: AST) announced today that the Company has signed a Notice of Grant Award (NGA) with the California Institute of Regenerative Medicine (CIRM), effective October 1, 2014. The NGA provides for the immediate release of Clinical Development payments and the release of additional grant funds pursuant to the previously announced $14.3 million CIRM grant award for clinical development of Asterias' product, AST-OPC1. The grant provides non-dilutive funding to initiate a Phase 1/2a clinical trial of AST-OPC1 in patients with complete cervical spinal cord injury and other product development activities for AST-OPC1.
"We are delighted to formally launch our collaboration with CIRM for the development of AST-OPC1 neural cells as a potential pluripotent stem-cell based therapy for spinal cord injury," stated Pedro Lichtinger, President and CEO of Asterias. "The signing of the Notice of Grant Award was the last in a series of milestones required to begin the release of funds under the CIRM grant."
In August 2014, Asterias received clearance from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1/2a clinical trial of AST-OPC1. The approved trial follows the successful completion of the Phase 1 clinical study of the product, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically-complete, thoracic spinal cord injury.
"There are currently no approved therapies for the more than 12,000 individuals who suffer a spinal cord injury each year in the United States alone, or for the approximately 1.3 million Americans who are estimated to be living with a spinal cord injury," Mr. Lichtinger continued. "Individuals with spinal cord injury have impaired limb function, and often suffer from a wide range of additional disabilities that can each significantly impact quality of life. AST-OPC1 has been shown to have three potentially reparative functions that address the complex pathologies observed at the spinal cord injury site: production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons. With the Phase 1/2a clinical trial, we look forward to generating additional data that could further support the potential for AST-OPC1 to serve as a new therapy for patients with spinal cord injury."
The new Phase 1/2a clinical trial is designed to assess safety and activity of escalating doses of AST-OPC1 for complete cervical spinal cord injuries, the first targeted indication for AST-OPC1. The trial will be an open-label, single-arm study testing three escalating doses of AST-OPC1 in 13 patients with subacute, C5-C7, neurologically-complete cervical spinal cord injury. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams to assess the safety and activity of the product. Selection of the clinical trial sites is well underway, and the Company expects to begin patient enrollment during the first quarter of 2015.
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