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Phase 2 ALS trial of Neuralstem's NSI-566 meets safety endpoints and shows 47% response rate

Mar. 12, 2015 7:30 AM ETPalisade Bio, Inc. (PALI) StockBy: Douglas W. House, SA News Editor22 Comments
  • A 15-patient Phase 2 clinical trial evaluating Neuralstem's (CUR) Orphan Drug-designated spinal cord-derived neural stem cells, NSI-566. for the treatment of amyotrophic lateral sclerosis (ALS) met its primary safety endpoints. The maximum tolerated dose of 16M transplanted cells and the surgery were well tolerated. Only one patient experienced a surgical serious adverse event.
  • The therapy involves transplanting NSI-566 cells directly into specific segments of the spinal cord where the cells integrate into the host motor neurons. Patients received up to 16M cells in 40 injections, which investigators believe is the maximum tolerated dose.
  • Secondary efficacy endpoints nine months after surgery show a 47% response rate (n=7/15) as measured by either near-zero slope of decline or positive slope of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score and by either a near-zero slope of decline or improvement in grip strength. ALSFRS is a standard clinical test used to assess ALS patients.
  • The average ALSFRS score for responders was 37 compared to an average score of 14 for non-responders. The responders retained 93% of their baseline score versus 35% for the non-responders. The difference was statistically significant. The average slope of decline for the responders was -0.007 point per day versus -0.1 point per day for non-responders. The difference was also statistically significant.
  • The complete data is being compiled into a manuscript for publication. A larger trial is expected to start this summer.
  • CUR is up 12% premarket on higher-than-normal volume.

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