Asterias provides update on AST-OPC1 SCiSTAR Phase 1/2a clinical study
Asterias Biotherapeutics reported that including the sixth and final patient in the AIS-A 10M cell cohort in the company's ongoing SCiStar Phase 1/2a clinical trial has further confirmed previously-announced motor function improvements at 6-months following administration of AST-OPC1. "We are excited to see the sixth and final patient in the AIS-A 10 million cell cohort show upper extremity motor function improvement at 3 months and further improvement at 6 months, especially because this particular patient's hand and arm function had actually been deteriorating prior to receiving treatment with AST-OPC1," stated Dr. Edward Wirth III, Chief Medical Officer. "We are very encouraged by the meaningful improvements in the use of arms and hands seen in the SciStar study to date since such gains can increase a patient's ability to function independently following complete cervical spinal cord injuries." The UEMS improvement at 6-months for the final patient was 9 points and in line with the median and average 6-month UEMS improvement for all six patients in this cohort (9.7 average; 9 median). In all six patients, administration of AST-OPC1 was followed by early improvements in UEMS at 3-months that were sustained or further increased through their most recent follow-up assessment. In addition to the motor score gains, the final patient in the AIS-A 10 million cell cohort has so far achieved a one motor level improvement over baseline on both sides of his body. All six patients in this cohort have now achieved at least a one motor level improvement over baseline on at least one side. The trial results to date continue to indicate a positive safety profile for AST-OPC1. There have been no serious adverse events related to AST-OPC1 and data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.