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CIRM grant will fund phase l/2a clinical trial stem cell SCI treatment.

MENLO PARK, Calif., October 20, 2014 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), the company that bought Geron Corporation's stem cell-related assets a year ago, has received a grant from the California Institute of Regenerative Medicine (CIRM) for clinical development of AST-OPC1, a possible treatment for cervical spinal cord injury.

The grant provides non-dilutive funding to initiate a Phase l/2a clinical trial of AST-OPC1 in patients with complete cervical spinal cord injury, and other product development activities for AST-OPC1.

In August 2014, Asterias received clearance from the 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.

The new Phase l/2a clinical trial is designed to assess safety and activity of escalating doses of ASTOPC1 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.

The Geron cell therapy assets included INDs for the clinical stage AST-OPC1 and AST-VAC1 programs, banks of cGMP-manufactured AST-OPC1 drug product, cGMP master and working cell banks of human embryonic stem cells, over 400 patents and patent applications filed worldwide including broad issued claims to fundamental platform technologies for the scalable growth of pluripotent stem cells and compositions of matter for several hESC-derived therapeutic cell types, research cell banks, customized reagents and equipment, and various assets relating to the AST-VAC2 program and preclinical programs in cardiology, and orthopedics.


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Title Annotation:In The Clinic
Publication:Stem Cell Lab World
Date:Oct 20, 2014
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