Asterias Biotherapeutics (AST) Receives DMC Clearance to Conduct High-Dose SCiStar Phase 1/2a
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Asterias Biotherapeutics, Inc. (NYSE: AST) announced that its Data Monitoring Committee (DMC) has reviewed the safety data from the initial cohort of three patients dosed with 2 million cells, and a subsequent five patients in the second cohort dosed with 10 million cells, and has cleared the company to now begin dosing a third cohort of 5-8 complete cervical injury patients (AIS-A patients) with the highest dose of 20 million cells. Concurrently, the study is also proceeding with enrolling the first cohort of 5-8 sensory incomplete cervical spinal cord injury patients (AIS-B patients), each of whom will be administered 10 million cells.
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) and is designed to evaluate the safety and efficacy of escalating doses of AST-OPC1 in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI), as well as newly injured patients with sensory incomplete SCI. These patients are commonly referred to as AIS-A and AIS-B patients, respectively. The results of the ongoing trial 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.
"The positive safety data in the previous phase 1 study and in the ongoing phase 1/2a study gives us the confidence to now proceed to administration of 20 million cells, which based on our significant pre-clinical research is likely well within the dosing range where we would expect to see clinically meaningful improvement in these patients," said Dr. Edward Wirth, Chief Medical Officer of Asterias Biotherapeutics.
The data set evaluating the efficacy results six months after implantation of 10 million AST-OPC1 cells in complete cervical spinal cord injury patients will be available in January 2017 and will focus on improvement in physical functioning of the upper extremities (fingers, hands and arms) of each treated patient utilizing scoring on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI scale). The published literature and opinion leaders in the spinal cord injury field indicate that a two motor level improvement in functioning utilizing this validated scale is clinically meaningful for these patients and should be the key measure in the evaluation of new therapies.
"According to the published scientific literature as well as key opinion leaders that we speak to, a two motor level improvement in physical functioning on the ISNCSCI scale can translate into a significant improvement in quality of life, reduced need for daily care and increased ability to live independently for patients with cervical spinal cord injuries. We look forward to announcing the six month follow up data from this 10 million cell cohort in January 2017," commented Steve Cartt, President & Chief Executive Officer.
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