NurOwn

Certain spinal fluid biomarkers may predict responses to NurOwn

Treatment with NurOwn (debamestrocel), which BrainStorm Cell Therapeutics is developing for amyotrophic lateral sclerosis (ALS), may bring about changes in biomarkers of inflammation and neurodegeneration that predict clinical outcomes. The findings come from the Phase 3 trial (NCT03280056) that tested NurOwn against a placebo in 189 adults with rapidly…

NurOwn and its exosomes given patents in Europe, Australia, Israel

BrainStorm Cell Therapeutics has received patents in Europe, Australia, and Israel covering the use of investigational NurOwn and NurOwn exosomes in treating amyotrophic lateral sclerosis (ALS) and other neurological disorders. The European patent specifically covers the use of an isolated population of mesenchymal stem cells —…

BrainStorm drops FDA application for NurOwn

BrainStorm Cell Therapeutics is withdrawing the application requesting U.S. approval of its cell-based therapy NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). The decision comes on the heels of a recent U.S. Food and Drug Administration (FDA) advisory committee meeting, in which experts ruled nearly unanimously…

FDA advisory committee votes against NurOwn approval for ALS

In a nearly unanimous vote, an advisory committee to the U.S. Food and Drug Administration (FDA) said there’s not enough evidence to support the efficacy of the experimental stem cell therapy NurOwn as a treatment for amyotrophic lateral sclerosis (ALS). The committee voted on a single question in its meeting: “Do…