The Food and Drug Administration told Brainstorm Therapeutics that rejiggered data from a negative clinical trial does not support the submission of a stem cell therapy for patients with amyotrophic lateral sclerosis, or Lou Gehrig’s disease, the company said Monday.
Despite the FDA’s recommendation that Brainstorm not seek the approval of its patient-specific ALS treatment called NurOwn, the company may still do so, but will consult with outside experts first before making a decision.
“We believe that we’ve been able to demonstrate a consistent and meaningful treatment effect of NurOwn, even though the trial failed to meet its primary endpoint,” Stacy Lindborg, Brainstorm’s head of global clinical research, told STAT. “Our hope was that the FDA would review the data and consider options to generate more evidence while providing relief to patients.”
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