DawsonJames analyst Jason Kolbert pointed out that in BrainStorm Cell Therapeutics Inc.'s (BCLI:NASDAQ) Q3/21 corporate presentation, management highlighted three sets of data, from preclinical to Phase 3, surrounding NurOwn. But the critical piece of information, according to Kolbert, is the Phase 3 study, evaluating the biotech's stem cell therapy in amyotrophic lateral sclerosis (ALS), failed.
"All the data has shown that the safety is great, but the efficacy, at best, is minimal and in auto-immune diseases, that waxes and wanes," Kolbert noted.
Because efficacy of the cell therapy in this indication is "small, at best," the analyst wrote, another large, expensive and long pivotal clinical trial of MSC-NTF cell therapy in ALS, with revised criteria for participation, will need to be conducted. At this point, whether or not Brainstorm intends to carry this out, and when and how are unknown.
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Disclosures for Dawson James Securities Inc., Brainstorm Cell Therapeutics Inc., Dec. 22, 2021
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