Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, today announced a positive outcome from an independent Data Review Panels review of the data generated by patients enrolled in the Companys ongoing Phase 1/2a SCiStar study 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 Food and Drug Administration (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.
Asterias worked with the California Institute for Regenerative Medicine (CIRM) to complete the review of the data under CIRMs Clinical Advisory Panel process. The Panel comprised of outside medical and scientific experts that include James Guest, M.D., Ph.D., Professor of Clinical Neurological Surgery at the University of Miami, John Steeves, Ph.D., Co-Chair of the Spinal Cord Outcomes Partnership Endeavor (SCOPE) and Professor of International Collaboration on Repair Discoveries (ICORD) at the University of British Columbia, and Ann Parr, MD, PhD, Neurosurgeon and Director of Spinal Neurosurgery at the University of Minnesota. The Panel reviewed the most recent safety, engraftment and efficacy data from the SCiStar study including analysis of the data after removing a small subset of subjects that are likely to be excluded from next trial.
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, commented Drs. Guest and 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 cohorts. The Company intends to report 12-month results for the entire SCiStar study in the first quarter of 2019. As previously announced, 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.
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