![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Brainstorm Cell Therapeutics Reports Disappointing Trial Results for ALS Treatment
Brainstorm Cell Therapeutics Reports Disappointing Trial Results for ALS Treatment
November 18, 2020
BrainStorm Cell Therapeutics reported that its NurOwn stem-cell therapy for amyotrophic lateral sclerosis (ALS), also called Lou Gehrig’s disease, failed to demonstrate efficacy in a phase 3 study.
Although the treatment did not achieve the primary endpoint, it did generate a statistically significant increase of neurotrophic factors and a reduction in neurodegenerative and neuroinflammatory biomarkers, the company said.
Despite the mixed trial results, BrainStorm CEO Chaim Lebovits said the N.Y.-based drugmaker is still committed to pursuing FDA approval for NurOwn and is in ongoing talks with the agency.
Upcoming Events
-
21Oct