biomarkers

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…

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…

NeuroSense Therapeutics’ combination therapy PrimeC led to a significant decline in certain biomarkers of amyotrophic lateral sclerosis (ALS) when used as an add-on to standard of care treatment, a study found. Standard treatment alone, meanwhile, appeared to have no impact on these disease-related biomarkers. The preliminary results come from…

Treatment with Coya Therapeutics‘ ALS001, a regulatory T-cell (Treg) therapy being developed for amyotrophic lateral sclerosis (ALS), was found to reduce markers of oxidative stress — a type of cell damage — and inflammation in a small early trial. The experimental Treg therapy was tested in a Phase 1…

An ambitious Irish research project, called Precision ALS, will combine clinical research, data science, and artificial intelligence (AI) to identify the multiple — and potentially targetable — factors involved in the development and progression of amyotrophic lateral sclerosis (ALS). The goal is to use this information to determine which treatments…

Note: This story was updated April 4, 2022, to clarify that 700 participants, including both ALS patients and healthy volunteers, have been recruited to the study. Mitsubishi Tanabe Pharma America (MTHA) has joined EverythingALS’s consortium to accelerate the development of new digital biomarkers for amyotrophic lateral…

In response to the National Institute of Neurological Disorders and Stroke‘s (NINDS) request for community input regarding what it should prioritize to accelerate amyotrophic lateral sclerosis (ALS) research, the ALS Association’s overarching message is this: move swiftly to help patients. NINDS, which is part of the National…

Urine levels of neopterin, a marker of inflammation, are linked to disease progression in people with amyotrophic lateral sclerosis (ALS), a study revealed. That means, according to researchers, that neopterin could be used as a biomarker to monitor disease status and determine whether certain treatments will be effective. The…

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…

Thanks to the implementation of proactive safety measures for the COVID-19 pandemic, Mitsubishi Tanabe Pharma America (MTPA) has enrolled at least 33 adults with amyotrophic lateral sclerosis (ALS) in its ongoing REFINE-ALS biomarker study. “ALS patient needs remain MTPA’s primary focus, so it was a priority to address the…