Asterias completes enrollment, dosing of AIS-A 20M cell cohort
Asterias Biotherapeutics announced completion of enrollment and dosing of the AIS-A 20M cell cohort in the company's ongoing SCiStar Phase 1/2a clinical study of AST-OPC1 in complete cervical spinal cord injury. In this cohort, five patients with AIS-A grade SCIs were administered 20M AST-OPC1 cells. The 20M AST-OPC1 cell dose is the highest to be investigated in the SCiStar Phase 1/2a clinical trial. The company expects to report top-line six-month results from this cohort in January 2018. Enrolling and dosing the fifth patient in this cohort triggers the final $1.5M grant payment from the California Institute for Regenerative Medicine under the existing $14.3M Strategic Partnerships Award grant awarded to Asterias. Asterias expects to receive this grant payment in the third quarter of 2017. Asterias has now completed enrollment and dosing in four of the five planned SCiStar study cohorts and enrolled twenty patients in the SCiStar study. Twenty-five patients have been administered AST-OPC1 after including patients from a previous Phase 1 safety trial and results-to-date continue to support the safety of AST-OPC1, with no serious adverse events related to AST-OPC1 or its administration. In June 2017, Asterias reported 9 month data from the AIS-A 10 million cell cohort that showed improvements in arm, hand and finger function observed at 3-months and 6-months following administration of AST-OPC1 were confirmed and in some patients further increased at 9-months. The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during the remainder of 2017 and 2018.