May 20, 2013
/PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) today reported that
, MD, PhD, principal investigator, presented updated Phase I data from its spinal cord-derived human neural stem cell (NSI-566) trial in the treatment of amyotrophic lateral sclerosis (ALS or
's disease) at the neuro diabetes special medical symposium in
, on Friday. In a talk called "Recent Therapeutic Advances in Stem Cell Therapy," Dr. Feldman outlined the design of the trial, which started with unilateral lumbar injections in non-ambulatory patients, and eventually progressed to bilateral lumbar injections, combined with unilateral cervical spinal injections, in ambulatory patients. She presented detailed data on all 15 patients and 18 procedures in the trial (three patients received additional transplants), including the clinically validated Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) ratings. The ALSFRS is a scale used to assess disability in ALS patients.
Dr. Feldman reported that six study patients have a stable, very slowly progressing or improved disease course at more than 700-to-approximately-850 days post-surgery. Furthermore, she stated that these patients all share two common clinical characteristics: They had no bulbar features of ALS, a form of the disease that destroys motor neurons in the corticobulbar area of the brainstem in the early stages and typically progresses faster than the limb-onset ALS. Additionally, these patients all received stem cell transplantation early in the course of their disease (at an average of 2 years, 1 month after symptom-onset). Two of the patients showing stabilization or improvement were among the three to receive transplants in both the lumbar and cervical regions.
Of the 9 remaining patients in the trial, three subjects had a long disease course (5.6, 11.6 and 12.7 years of known disease), at the time of their transplantation, likely representing atypical ALS, and have had little change in the trajectory of their disease. Finally, Dr. Feldman reported, six of the trial patients died of their disease, 7-to-30 months after surgery. Two of these patients had features of bulbar ALS at the time of their transplantation.