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$AST - Asterias Biotherapeutics Announces Positive Efficacy Data in Patients with Complete Cervical Spinal Cord Injuries Treated with AST-OPC1

http://asteriasbiotherapeutics.com/asterias-biotherapeutics-announces-positive-efficacy-data-in-patients-with-complete-cervical-spinal-cord-injuries-treated-with-ast-opc1/

A week old...but, very interesting... and look forward to final results.

FREMONT, Calif. – Sept. 14, 2016 – Asterias Biotherapeutics, Inc. (NYSE MKT: AST), today presented positive interim efficacy data from the 10 million cell cohort in the Company’s ongoing AST-OPC1 SCiSTAR Phase 1/2a multicenter clinical study in complete cervical spinal cord injury patients. 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. 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, patients with complete cervical spinal cord injuries that show two motor levels of improvement on at least one side may regain the ability to perform daily activities such as feeding, dressing and bathing.

The efficacy target was recommended by the independent Spinal Cord Outcomes Partnership Endeavor (SCOPE) based on recently published data (Steeves et al., Topics in Spinal Cord Injury Rehabilitation, 2012). SCOPE is affiliated with the American Spinal Injury Association.

“I am very encouraged by this first look at efficacy data for AST-OPC1 in complete cervical spinal cord injury patients,” commented Shekar N. Kurpad, MD, PhD, Professor of Neurosurgery, Director, Spinal Cord Injury Center Medical College of Wisconsin. “As a clinical investigator in the trial, I am looking forward to continuing the evaluation of this promising new treatment in these patients, for whom effective new therapeutic options are desperately needed. I am hopeful that we are able to see these early, positive efficacy trends continue as the study progresses.”

“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,” said Steve Cartt, Chief Executive Officer of Asterias. “We are quite encouraged by this first look at efficacy results and look forward to reporting six-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.”

The SCiStar study is funded in part by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM).