BrainStorm Announces Positive Data On Cell Therapy NurOwn As Treatment For Progressive MS; Stock Up

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) said that its phase 2 study, which evaluated NurOwn or MSC-NTF cells as a treatment for progressive multiple sclerosis, achieved the primary endpoint of safety and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers.

In Wednesday pre-market trade, BCLI was trading at $4.75 up $0.83 or 21.17 percent.

"These positive results indicate the potential of MSC-NTF cells to lessen inflammatory mechanisms, promote repair, and restore function in progressive MS, a condition for which there is great need for effective therapy," said Jeffrey Cohen, M.D, Director of Experimental Therapeutics.

The 28-week open-label phase 2 clinical trial enrolled 20 primary and secondary progressive MS patients based on the 2017 revised McDonald Criteria, ages 18-65, with baseline Expanded Disability Status Scale scores between 3-6.5, without evidence of relapse within 6 months of enrollment, able to walk 25 feet in 60 seconds or less and were permitted to be on a stable dose of disease modifying therapy.

Of the 20 patients enrolled, 18 were treated and 16 (80%) completed the study. Two patients discontinued related to procedure-related AEs. There were no study deaths or AEs related to multiple sclerosis worsening.

As per the study results, 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, and was observed in 0% of the pre-specified matched historical controls in the CLIMB registry.

Thirty eight percent of NurOwn treated patients showed at least a 10-point improvement in the MSWS-12 from baseline to week 28, a patient reported outcome that evaluates walking function.

In addition, 47% of treated patients showed at least an 8-letter improvement across 28 weeks in the low contrast letter acuity test, a visual function test, and 67% showed at least a 3-point improvement in the symbol digit modality test, a measure of cognitive processing.