NurOwn

People with amyotrophic lateral sclerosis (ALS) who continued treatment with NurOwn (debamestrocel) after completing a Phase 3 trial experienced additional benefits with extended treatment, data show. The findings come from 10 adults who received up to six additional doses of NurOwn over nearly one year in an expanded…

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…

The U.S. Food and Drug Administration (FDA) has agreed on the design of a Phase 3b trial that will test the investigational cell-based therapy NurOwn (debamestrocel) in amyotrophic lateral sclerosis (ALS) patients with less advanced disease. The developer, BrainStorm Cell Therapeutics, plans to launch the trial…

Note: This story was updated March 6, 2024, to correct the poster was presented by Brainstorm’s executive vice president and chief development officer Bob Dagher. A pivotal, Phase 3b clinical trial is planned to test the cell-based therapy NurOwn (debamestrocel) in people with amyotrophic lateral sclerosis (ALS),…

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 Cell Therapeutics has had a meeting with the U.S. Food and Drug Administration (FDA) seeking an agreement on its plans for a confirmatory Phase 3b trial of NurOwn, a cell-based treatment the company is developing for amyotrophic lateral sclerosis (ALS). The main goal of the meeting,…

BrainStorm Cell Therapeutics is making strategic adjustments — including cuts in its workforce — to accelerate the clinical development of NurOwn as an amyotrophic lateral sclerosis (ALS) treatment. The decision follows the recent withdrawal of its regulatory application with the U.S. Food and Drug Administration…

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…

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…

The U.S. Food and Drug Administration (FDA) has shared its major concerns with data available for NurOwn, BrainStorm Cell Therapeutics‘ experimental stem cell therapy for amyotrophic lateral sclerosis (ALS). According to a new briefing document put out by the FDA, the agency believes that currently…