$BTX news: Asterias, Sub, provides an update about AST-OPC1:
As you'll recall, the medical researchers were wondering if the wonderful results gotten on AIS-A patients (extraordinary spinal trauma) may be even better with AIS-B patients will lesser degree of trauma. We will see come Jan 2018.
FREMONT, Calif., July 12, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (AST), a biotechnology company pioneering the field of regenerative medicine, today announced completion of enrollment and dosing of the AIS-B 10 million cell cohort in the company's ongoing SCiStar Phase 1/2a clinical study of AST-OPC1 in complete cervical spinal cord injury (SCI). In this cohort, five patients with AIS-B grade SCIs were administered 10 million AST-OPC1 cells. The company expects to report top-line six-month results from this cohort in January 2018.
"Completing enrollment and dosing of the first cohort of AIS-B patients marks another important milestone for our AST-OPC1 program," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "AIS-B patients have some levels of sensation following their injury but like AIS-A patients have severe spinal cord injuries and no meaningful motor function below the injury site. We have already reported meaningful improvements in arm, hand and finger function for AIS-A patients dosed with 10 million AST-OPC1 cells and we are looking forward to reporting initial efficacy and safety data for this cohort early in 2018."
The SCiStar study has now completed enrollment and dosing in three of the five planned cohorts. The first completed cohort included three AIS-A patients who were administered a low dose of 2 million AST-OPC1 cells for the purpose of evaluating the safety of administering AST-OPC1 in the cervical spinal cord. The second completed cohort (Cohort 2) included six AIS-A patients who were administered 10 million AST-OPC1 cells, which is the first cohort dosed within the predicted efficacy dose range of 10 million to 20 million cells. In June 2017, Asterias reported 9 month data from Cohort 2 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. Asterias will report 12-month efficacy and safety data from Cohort 2 later this year after the 12-month results are collected for the entire cohort.
The company is currently enrolling AIS-A patients dosed with the highest dose of 20 million cells, and the study's final cohort of AIS-B patients receiving 20 million AST-OPC1 cells is planned to begin enrollment later this quarter. The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during 2017 and 2018.
On July 10, 2017, Asterias announced that the U.S. Food and Drug Administration accepted the company's amendment to the clinical research protocol for the SCiStar study. The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window from 14 to 30 days to 21 to 42 days post-injury.
