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Positive Outcome From Data Review Of OPC1 Spinal Cord Injury Study.

FREMONT, Calif., October 31, 2018 -Asterias Biotherapeutics, Inc. (NYSE American: AST) announced a positive outcome from an independent Data Review Panel's review of the data generated by patients enrolled in the company's ongoing Phase 1/2a SCiStar study (NCT02302157).

The three-year clinical trial ("A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury"), scheduled for completion in December, was designed to evaluate the safety and efficacy of OPC1 in the treatment of severe cervical spinal cord injury.

Based on a review of the data, the panel recommended moving forward with the continued clinical development of OPC1. The next step in the development of OPC1 is a meeting with the Food and Drug Administration (FDA) later this year to discuss proposed next steps for the OPC1 clinical development program, including the trial design for a randomized controlled Phase 2 trial.

"We believe the the positive feedback we received from the panel will strengthen our meeting with the FDA later this year," commented Ed Wirth, Chief Medical Officer of Asterias. "Assuming successful execution of the FDA meeting and obtainment of additional CIRM funding or alternative financing, we expect to enroll the first patient in the Phase 2 randomized controlled trial in the first half of 2020."

"From our review of the data, the combination of the safety of the cells and administration procedure, the level of motor recovery, and the compelling evidence of the engraftment of OPC1 cells is an unprecedented step forward for the program and spinal cord injury community," said panel members James Guest and John Steeves.

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of OPC1 administered at up to 20 million OPC1 cells in 25 subjects with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) spinal cord injuries.

Asterias has completed enrollment and dosing in all five of its planned SCiStar study co-horts.

The company intends to report 12-month results for the entire SCiStar study in the first quarter of 2019.

The company has scheduled a Type B meeting with the FDA in accordance with the Regenerative Medicine Advanced Therapy (RMAT) designation under the 21st Century Cures Act.

OPC1, an oligodendrocyte progenitor cell population derived from human embryonic stem cells, has been shown in preclinical testing in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed in demyelination disorders, such as spinal cord injury and multiple neurodegenerative diseases, including multiple sclerosis and white matter stroke.

These potential reparative functions of OPC1 include the production of neurotrophic factors, the stimulation of vascularization, and the induction of remyelination of denuded axons, all of which are critical for survival and regrowth of --and conduction of nerve impulses through--axons at the injury site.


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Title Annotation:Clinical Trials
Publication:Stem Cell Lab World
Date:Nov 12, 2018
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