Brainstorm Cell Therapeutics reported disappointing results Tuesday from a late-stage clinical trial involving its experimental stem cell therapy for patients with amyotrophic lateral sclerosis, or Lou Gehrig’s disease.
In the Phase 3 study, three spinal injections of the bespoke treatment called NurOwn failed to slow the neurological decline of ALS patients compared to placebo injections. NurOwn performed as anticipated, but a better-than-expected placebo response caused the final analysis to miss statistical significance by a wide margin, Brainstorm said.
Despite the negative study results, “informal discussions” between the company and the Food and Drug Administration are being held to determine if certain types of ALS patients with less severe disease might benefit enough from the treatment to support approval.
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