NurOwn

Two years after my husband, Todd, was diagnosed with ALS, I read an article that gave me hope. An Israeli rabbi who had ALS saw improvement with NurOwn, an experimental stem cell treatment by BrainStorm Cell Therapeutics. The man went from being in a wheelchair to walking. I…

The small difference in treatment responses among amyotrophic lateral sclerosis (ALS) patients receiving NurOwn versus a placebo in a recent clinical trial likely was due to chance, the U.S. Food and Drug Administration (FDA) announced in a press release. Along with slightly more deaths in the NurOwn…

Existing safety and effectiveness data from a Phase 3 clinical trial of NurOwn — an investigational cell-based therapy for amyotrophic lateral sclerosis (ALS) — are not sufficient to support the therapy’s approval, the U.S. Food and Drug Administration (FDA) concluded in an initial review. According to the…

BrainStorm Cell Therapeutics met with U.S. Food and Drug Administration (FDA) officials regarding its plans for a semi-automatic manufacturing process for NurOwn, the company’s investigational cell-based therapy for amyotrophic lateral sclerosis (ALS). Discussion at the meeting — formally called a type C meeting — covered issues that…

BrainStorm Cell Therapeutics has opened an expanded access program (EAP) in the U.S. to allow certain amyotrophic lateral sclerosis (ALS) patients to gain access to its investigational cell-based therapy NurOwn. EAPs, also known as compassionate use programs, are intended to make investigational therapies available outside of a clinical…

BrainStorm Cell Therapeutics’ cell-based therapy NurOwn failed to significantly slow disease progression in people with rapidly progressing amyotrophic lateral sclerosis (ALS), top-line data from a Phase 3 trial show. The therapy, however, did result in clinically meaningful responses in a pre-specified group of patients with early ALS…

Catalent Biologics has agreed to manufacture NurOwn, the cell-based therapy by BrainStorm Cell Therapeutics being evaluated in a soon-to-conclude pivotal trial as a possible treatment of amyotrophic lateral sclerosis (ALS). With this agreement, Catalent will produce NurOwn under current Good Manufacturing Practices — standards set to ensure that batches…

BrainStorm Cell Therapeutics is sharing the details of the design of its Phase 3 clinical trial evaluating NurOwn as a treatment for people with rapidly progressing amyotrophic lateral sclerosis (ALS), showing that the trial is…

The Japan Patent Office has granted a patent to Brainstorm Cell Therapeutics covering the proprietary technique that generates the company’s cell-based therapy NurOwn from mesenchymal stem cells (MSCs). Through this technique, researchers can harness MSCs directly from a patient and mature them into cells that produce…

BrainStorm Cell Therapeutics’ cell-based therapy NurOwn increases the number of immunosuppressive cells and lessens inflammation, according to a small preclinical study. These immunoregulatory effects, along with NurOwn’s neuroprotective and neuroreparative properties, may be key to halt the progression of amyotrophic lateral sclerosis (ALS) and other neuroinflammatory diseases, including…