Asterias Biotherapeutics (AST) Commences Dosing of First Patient in AST-OPC1 Clinical Trial
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Asterias Biotherapeutics, Inc. (NYSE: AST) announced that the first patient with incomplete AIS-B cervical spinal cord injury was successfully dosed with 10 million cells of AST-OPC1 (oligodendrocyte progenitor cells) in the SCiSTAR clinical trial at Shepherd Center in Atlanta. The company recently received FDA clearance to expand the study into this additional patient population based on the continued favorable safety profile observed in the ongoing clinical study. A total of 5-8 AIS-B patients are expected to be enrolled and dosed with 10 million cells in the study. Asterias recently reported positive early efficacy data for AST-OPC1 in AIS-A patients, or those with complete cervical spinal cord injuries.
"We have been very encouraged by the first look at the early efficacy data, as well as the safety profile, for AST-OPC1 in AIS-A patients, and now look forward to also evaluating efficacy and safety in AIS-B patients," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "AIS-B patients also have severe spinal cord injuries, but compared to AIS-A patients they have more spared tissue in their spinal cords. This may allow these patients to have a greater chance of meaningful functional improvement after being treated with AST-OPC1 cells."
"As someone who regularly treats patients who have sustained paralyzing spinal cord injuries, I am encouraged by the progress we've seen in evaluations of AST-OPC1 in people with AIS-A injuries, particularly the improvements in hand, finger and arm function," said Donald Peck Leslie, M.D., medical director of Shepherd Center and principal investigator for this study site. "Now, I am looking forward to continuing the evaluation of this promising new treatment in AIS-B patients, as well."
The SCiSTAR study is an ongoing Phase 1/2a clinical trial funded in part by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM). The trial results to date continue to support a positive safety profile for AST-OPC1. There have been no serious or unexpected adverse events related to AST-OPC1, the administration procedure or the accompanying short course of low-dose immunosuppression in any of the patients treated with AST-OPC1, including five patients in an earlier Phase 1 trial with neurologically complete thoracic SCI.
Earlier this month, Asterias presented positive early efficacy data from five AIS-A patients that had been dosed with 10 million AST-OPC1 cells in the SCiSTAR study. While early in the study, with only 4 of the 5 patients in the cohort having reached 90 days after dosing, all patients have shown at least one motor level of improvement so far and the efficacy target of 2 of 5 patients in the cohort achieving two motor levels of improvement on at least one side of their body has already been achieved. One of these patients achieved a two motor level improvement on both sides of his body. Patient improvements are being measured by the ISNCSCI neurological classification scale widely used to quantify functional status of patients with spinal cord injuries. As suggested by existing research in patients with complete cervical spinal cord injuries, a two motor level improvement is correlated with a significant increase in functional ability, as well as the ability for patients to care for themselves, since so many activities of daily living are dependent on arm and hand function [Steeves, et al, 2012].
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