Interim Data on Neuralstem ALS Phase I Trial Announced

Eva Feldman, M.D., Ph.D., Principal Investigator of the Phase I safety trial of Neuralstem Inc's human spinal cord stem cells in ALS, presented primary and secondary endpoint data on the first 12 patients at the American Neurological Association's annual meeting.  The report indicates the procedure to be safe and some improvement in motor function.

“Eight out of ten living subjects in the trial showed lower extremity function scores that remained the same or improved after treatment,” commented Dr. Feldman.  “Two out of ten showed continued decline of lower extremity function.  The sample size and follow-up time are too limited to draw any conclusions, but we are encouraged by the safety profile of our approach.”

“We are pleased to hear the progress in the study and the encouraging safety profile in patients,” said ALS Association Chief Scientist Lucie Bruijn.  “We look forward to learning more about the study results as it becomes available.”

The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010.  Twelve patients have been transplanted in the lumbar region of the spine.  The last of these was transplanted in April, 2011.  The trial is designed to transplant up to 18 patients.  After a required FDA safety data approval, the trial is expected to progress to include cervical injections for the last six patients.