BrainStorm Cell Therapeutics Inc BCLI has reported topline Phase 2 data evaluating three repeated administrations of NurOwn (MSC-NTF cells), each given two months apart, as a treatment for progressive multiple sclerosis (MS).
- The study achieved the primary endpoint of safety, and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers.
- Prespecified 25% improvements in the timed 25-foot walk and 9-hole peg test from baseline to 28 weeks were observed in 14%, and 13% of NurOwn treated patients, respectively, compared to 0% in matched historical controls.
- 38% of the patients in treatment showed at least a 10-point improvement on the walking scale from baseline to week 28.
- Also, 47% of NurOwn treated patients showed at least an 8-letter improvement across 28 weeks in a visual function test, and 67% showed at least a 3-point improvement on the cognitive processing scale.
- NurOwn treated patients showed a mean improvement from baseline of 10% in 25-foot walk measure and a 4.8% improvement from baseline on the 9-9 hole peg test dominant hand, compared to 1.8% and 1.4% worsening respectively in matched historical controls.
- Also, NurOwn treated patients showed a 6% improvement from baseline on the walking scale.
- An increase in neuroprotective molecules and a decrease in neuroinflammatory biomarkers were observed.
- Additional secondary efficacy data and detailed cerebrospinal fluid and blood biomarker analyses are currently underway and will be reported at upcoming scientific meetings.
- Of the 20 patients enrolled, 18 were treated, and 16 completed the study. Two patients discontinued related to procedure-related adverse events. There were no study deaths or adverse events related to multiple sclerosis worsening.
- Price Action: BCLI shares surge 21.9% at $4.78 in premarket trading on the last check Wednesday.
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