Asterias Biotherapeutic’s study supports the safety of the injection procedure for the spinal cord injury clinical trial with no reported serious adverse events.
Asterias Biotherapeutics, Inc. (CA, USA), a biotechnology company focused on the emerging field of regenerative medicine, announced that a third patient was successfully dosed in a Phase 1/2a clinical trial evaluating activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury. This is the final patient treated at the initial low-dose (2 million cells) safety cohort. The results of the study continue to support a robust safety profile for AST-OPC1, with no serious adverse events observed in any of the three treated patients to date.
The first patient in this cohort was dosed at Shepherd Center in Atlanta (USA, GA) and has completed the 2-month post-injection assessment. “This progress in the first patient is very encouraging and is observed in less than 5 percent of our AIS A patients at this stage of their recovery,” commented Donald Peck Leslie, principal investigator at Shepherd Center
The lead neurosurgeon for the study, Richard Fessler from Rush University Medical Center (IL, USA), performed the AST-OPC1 injections in the second and third patients. “The injection procedure went very smoothly for both patients and there were no complications,” explained Fessler. “Both patients recovered quickly from the injection surgery and were able to resume their rehabilitation programs soon afterward.”
The Company expects to begin enrollment of the second dose cohort following Data Monitoring Committee review of the 30-day post-injection safety data from all three patients. The second cohort will enroll five patients who will receive a higher dose of 10 million AST-OPC1 cells. “The safety data in this first cohort now paves the way for testing the higher doses of AST-OPC1 (10-20 million cells) that we believe correspond most closely to the doses that showed the greatest efficacy in animal studies,” stated Edward Wirth, Chief Medical Officer of Asterias.
The study is being currently conducted at three centers and will include up to twelve centers in the US. Enrollment in the trial has already begun to accelerate, with 7 weeks elapsed between dosing the first and second patients, and only 3 weeks between dosing the second and third patients.
“We are encouraged by this performance improvement and are confident in meeting our disclosed timelines,” concluded Pedro Lichtinger, President and CEO of Asterias. “We expect to provide updates as identified milestones are reached or when major events occur.”
Asterias Biotherapeutics press release: http://asteriasbiotherapeutics.com/asterias-biotherapeutics-concludes-recruitment-of-initial-safety-cohort-of-the-scistar-phase-12a-dose-escalation-clinical-trial-of-ast-opc1-for-complete-cervical-spinal-cord-injury/