Oxford BioDynamics has announced that the first patient has been enrolled in the REFINE-ALS clinical study, designed to identify and measure specific biomarkers and clinical assessments in up to 300 people with amyotrophic lateral sclerosis (ALS) who are taking Radicava (edaravone).
The study includes assessments of biomarkers for oxidative stress, inflammation, neuronal and muscle injury. Biomarkers will be measured prior to initiating treatment with Radicava, at the start of treatment, and at pre-specified time points throughout the 24-week study period (six cycles of treatment). Mitsubishi Tanabe, the sponsor of the trial, has announced that results are expected in 2020.
The initiation of the study marks the company’s first clinical research in the United States, and includes approximately 40 sites across the country, utilising the expertise of multiple specialty laboratories to assess biomarker samples.
As part of the research, investigators will use “cutting-edge” technology, such as Oxford BioDynamics’ EpiSwitch - which assesses a novel class of epigenetic biomarkers aimed at understanding the rate of disease progression.
Other technology, such as SomaLogic’s SomaScan, will be used to measure the changing levels of approximately 5,000 proteins throughout the body, providing a comprehensive and real-time picture of biologic activity and insights that have the potential to further understanding of a treatment’s effect.
ALS is a “multifaceted and complex disease with few treatment options,” said primary investigator James Berry, Massachusetts General Hospital NCRI, Boston.
He went on to say that the hospital is “proud to be investigating the biological impact of Radicava on this disease using a combination of genomic analysis and cutting edge biomarker platforms, potentially enhancing our understanding of the disease and its treatments and improving clinical treatment plans for people with ALS.”
ALS, also known as motor neurone disease, is a specific disease that causes the death of neurons controlling voluntary muscles.