Phase 3 trial

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,…

Biological samples from amyotrophic lateral sclerosis (ALS) patients who took part in the Phase 3 clinical trial of NurOwn, a cell-based therapy, are being donated by BrainStorm Cell Therapeutics to a repository for use by the research community. The samples include blood and spinal fluid (cerebrospinal fluid or CSF)…

The investigational cell-based therapy NurOwn may slow disease progression in people with amyotrophic lateral sclerosis (ALS) who have less severe disease, according to analyses from a Phase 3 trial. Researchers’ analyses excluded patients with the lowest scores on the ALS Functional Rating Scale–Revised (ALSFRS-R) or in individual…

The Phase 3 clinical trial testing an oral suspension formulation of edaravone for amyotrophic lateral sclerosis (ALS) has resumed dosing and patient recruitment, its developer, Mitsubishi Tanabe Pharma America (MTPA), announced. The trial (NCT04165824) was launched in November, but was paused in March due to the COVID-19 pandemic. The study,…

Patient dosing has finished in the pivotal Phase 3 trial assessing the safety and efficacy of repeat administrations of NurOwn, a cell-based therapy for people with amyotrophic lateral sclerosis (ALS), BrainStorm Cell Therapeutics, the therapy’s developer, announced. The Phase 3 trial (NCT03280056), which enrolled…

Seneca Biopharma announced that work is underway to advance NSI-566, its leading stem cell treatment candidate, into a Phase 3 study in people with amyotrophic lateral sclerosis (ALS). The decision followed a meeting with the US Food and Drug Administration (FDA), and is supported by data collected from…

Mitsubishi Tanabe Pharma America (MTPA) has enrolled a first patient in a Phase 3 clinical trial of an oral suspension formulation of edaravone in treating amyotrophic lateral sclerosis (ALS). An intravenous form of edaravone (given directly into the bloodstream), developed by Mitsubishi Tanabe Pharma and sold under the brand…

The Phase 3 REFALS trial exploring the impact of oral levosimendan (ODM-109) in patients with amyotrophic lateral sclerosis (ALS) has completed its target enrollment, the therapy’s manufacturer, Orion, announced. A total of 496 participants were recruited across 104 sites in the United States, Canada, Europe, and Australia. They…

The U.S. Food and Drug Administration has given positive feedback to MediciNova’s Phase 3 developmental plan for its investigational therapy ibudilast (MN-166) for amyotrophic lateral sclerosis (ALS). Following the FDA’s guidance and suggestions, the company will design a trial that determines the maximum benefit of the treatment,…

BrainStorm Cell Therapeutics’ latest financial results guarantee enough capital to complete the ongoing Phase 3 trial of amyotrophic lateral sclerosis (ALS) therapy candidate NurOwn, according to an update from the company. In addition, the company recently announced it has received patents in Japan and Europe for NurOwn.