Efficacy data from the ongoing AST-OPC1 SCiSTAR Phase 1/2a multicenter clinical study, presented by Asterias Biotherapeutics Inc, suggests improvement among the complete cervical spinal cord injury patients who participated in the study.
Edward Wirth, MD, PhD, chief medical officer of Asterias, presented the data at the recent 55th Annual Scientific Meeting of the International Spinal Cord Society in Vienna, Austria.
A media release from Asterias notes highlights from the presentation.
Among patients in cohort 2, dosed with 10 million cells, five out of five patients exhibited improved upper extremity motor scores (UEMS) relative to baseline; at Day 90 of follow up, four of four patients dosed have improved one motor level on at least one side, two of four patients have improved two motor levels on at least one side, and one patient has improved two motor levels on both sides.
In addition, the average UEMS improvement at Day 90 for the four patients that have reached this follow up was 9.5 points; and the results to date from Cohort 2 show no serious adverse events related to AST-OPC1, the injection procedure, or immunosuppression with low-dose tacrolimus. In addition, data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.
Among patients in cohort 2, dosed with 2 million cells, three out of three patients have exhibited improved upper extremity motor scores (UEMS) relative to baseline; the average UEMS improvement for the three patients was 5.0 points at Day 90, and they continued to improve an average of 7.0 points at 1 year.
Despite the very low dose used in this safety cohort, at 1 year of follow up one patient in Cohort 1 has improved one motor level on one side and two patients have improved one motor level on both sides; and the 12-month results from Cohort 1 show no serious adverse events related to AST-OPC1, the injection procedure, or immunosuppression with low-dose tacrolimus. In addition, data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury, the release continues.
“The results to date in the 10 million cell cohort, while still early, demonstrate meaningful improvement in motor function, particularly in the use of a patient’s hands, fingers, and arms, which is critically important for a patient’s quality of life and ability to function independently,” says Steve Cartt, chief executive officer of Asterias, in the release.
“We are quite encouraged by this first look at efficacy results and look forward to reporting 6-month efficacy data as planned in January 2017. We have also just recently been cleared to begin enrolling a new cohort and administering to these new patients a much higher dose of 20 million cells. We look forward to begin evaluating efficacy results in this higher-dose cohort in the coming months as well,” he adds.
[Source(s): Asterias Biotherapeutics Inc, PR Newswire]