cell therapy

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 is preparing to file an application with the U.S. Food and Drug Administration (FDA) requesting approval of its cell-based therapy NurOwn for amyotrophic lateral sclerosis (ALS). The decision to submit a biologics license application was based on “the totality of the evidence from NurOwn’s clinical…

A significantly greater proportion of amyotrophic lateral sclerosis (ALS) patients with less severe disease showed slower ALS progression with the investigational cell-based therapy NurOwn relative to a placebo. These are the findings of another post-hoc analysis of data from NurOwn’s Phase 3 clinical trial (NCT03280056), further supporting the…

Brainstorm Cell Therapeutics‘ investigational cell-based therapy, NurOwn, might be able to slow disease progression and be of “meaningful” benefit to  people with less severe amyotrophic lateral sclerosis (ALS), according to new analyses of Phase 3 trial data. The company announced last year that its Phase 3 trial…

BrainStorm Cell Therapeutics announced that a new cleanroom facility for manufacturing NurOwn, its experimental cell-based therapy for amyotrophic lateral sclerosis (ALS), has received good manufacturing practice (GMP) certification from the Israel Ministry of Health. GMPs are standards set to ensure that batches of a medicine are produced with consistent high…

Note: This story was updated April 6, 2021, to note that the study is expected to conclude late this summer, instead of 2024. The ALS Association, Muscular Dystrophy Association (MDA), and ALS Finding a Cure have given an additional $1.1 million to support work on a cell therapy…

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…

Coya Therapeutics has raised $10 million in funding to advance the development of ALS001, a potential regulatory T-cell (Treg) therapy aiming to halt amyotrophic lateral sclerosis (ALS) progression, now in a Phase 2 study in patients. Proceeds raised in this series A funding round will also be used to…