Update for its OPC1 Phase 1/2a Clinical Trial in Severe Spinal Cord Injury
PRESS RELEASE GlobeNewswire Jan. 24, 2019, 07:00 AM
FREMONT, Calif., Jan. 24, 2019 (GLOBE NEWSWIRE) -- 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 provided top-line 12 month data from the Company’s Phase 1/2a SCiStar study designed to evaluate the safety and potential efficacy of OPC1 in the treatment of severe cervical spinal cord injury (SCI). All 25 subjects from the SCiStar study have now completed 12-months of follow-up as part of the study’s protocol. The Company also held a Type B meeting with the Food and Drug Administration (FDA) late last year where FDA agreed with the Company’s plan to initiate a randomized, controlled Phase 2 study to further evaluate the safety and efficacy of OPC1.
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https://markets.businessinsider.com/...ury-1027892664
PRESS RELEASE GlobeNewswire Jan. 24, 2019, 07:00 AM
FREMONT, Calif., Jan. 24, 2019 (GLOBE NEWSWIRE) -- 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 provided top-line 12 month data from the Company’s Phase 1/2a SCiStar study designed to evaluate the safety and potential efficacy of OPC1 in the treatment of severe cervical spinal cord injury (SCI). All 25 subjects from the SCiStar study have now completed 12-months of follow-up as part of the study’s protocol. The Company also held a Type B meeting with the Food and Drug Administration (FDA) late last year where FDA agreed with the Company’s plan to initiate a randomized, controlled Phase 2 study to further evaluate the safety and efficacy of OPC1.
more...
https://markets.businessinsider.com/...ury-1027892664
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