Asterias Provides Top Line 12 Month Data Update for its OPC1 Phase 1/2a Clinical Trial

Asterias Biotherapeutics (NYSE: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).

As quoted in the press release:

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.

“We believe the primary goal of SCiStar, which was to observe the safety of OPC1 in cervical spinal cord injury patients and to accumulate data related to important factors for the design of later-stage trials, such as optimal dosing levels, timing of OPC1 injection after SCI, the immunosuppression regimen, engraftment of the cells, and rates of motor recovery observed among different study subpopulations, have been successfully achieved,” commented Ed Wirth, Chief Medical Officer.  “We have also reached preliminary agreement with FDA on the next steps for the clinical development of OPC1, including the eligibility criteria, dose level, and proposed study design for the next clinical trial.  We expect to provide an update on the OPC1 program later this year after the merger with BioTime, Inc. has closed.”

Click here to read the full press release.