Despite Failing to Reach Endpoint in Phase 3 ALS Study, Brainstorm Plans to Move Forward with Development of NurOwn Stem Cells

Despite Failing to Reach Endpoint in Phase 3 ALS Study, Brainstorm Plans to Move Forward with Development of NurOwn Stem Cells

Brainstorm Cell Therapeutics reported topline results from a Phase 3 trial evaluating NurOwn (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). Although the data showed a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results. However, NurOwn did result in a clinically meaningful treatment response compared to placebo in a pre-specified subgroup of patients with early disease. NurOwn treatment also led to significant increases in neurotrophic factors as well as a reduction in both neuroinflammatory and neurodegenerative biomarkers.

The multi-center, placebo-controlled, randomized, double-blind trial was designed to evaluate the safety and efficacy of NurOwn in 189 ALS patients. It was conducted at six medical centers: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Ma...

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