Oxford BioDynamics has joined the REFINE-ALS study, a project designed to detect and measure the levels of specific biomarkers among people with amyotrophic lateral sclerosis (ALS), Mitsubishi Tanabe Pharma America (MTPA) announced.
REFINE-ALS is sponsored by the MTPA and led by the Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI), which have recently entered into a collaboration agreement to drive the initiative.
The prospective, observational, longitudinal, multicenter study will analyze the levels of specific biomarkers involved in oxidative stress — the cellular damage that occurs as a consequence of high levels of oxidant molecules — inflammatory response, neuronal injury or death, and muscle injury in a group of up to 300 ALS patients from 40 different sites across the U.S.
All participants will receive six cycles of Radicava (edaravone) over a period of 24 weeks. Biomarker levels and ALS progression will be assessed at three major points: before starting the treatment, at the start of therapy, and at specific time points over the course of the 24 weeks.
Data on patients’ biomarkers will be compared with information from biorepositories, while evidence of disease progression will be measured against models for ALS.
“ALS is a complex disease and the specific causes of disease onset and progression are not fully understood,” Stephen Apple, MD, senior director of medical affairs at MTPA, said in a press release. “Through this biomarker study we are seeking to enhance our understanding of Radicava therapy in ALS. We are proud to announce Oxford BioDynamics has joined us in this effort and we look forward to seeing the data we gain from their technologies.”
Oxford BioDynamics’ contribution to REFINE-ALS will come from its EpiSwitch proprietary technology. This new platform was developed to study a special group of epigenetic biomarkers, called chromosome conformation signatures, or CCSs, that may provide hints to the rates of ALS progression and treatment effects.
Epigenetics is the research field that studies how chemical modifications that affect gene expression are inherited, even though they are not encoded in the cell’s DNA.
“ALS is a challenging disease and we’re excited to apply the EpiSwitch technology to uncover more information about its progression,” said Alexandre Akoulitchev, chief scientific officer at Oxford
“We are very pleased that OBD [Oxford BioDynamics] has been selected for this pivotal prospective trial led by the world leaders in ALS therapeutic development and patient care. As an extension of our previous work in ALS based on collaborations with ALS experts, this is an acknowledgment of the utility and value that EpiSwitch offers. We look forward to collaborating with our study partners to help disease understanding and clinical care for the entire ALS community,” Akoulitchev added.
REFINE-ALS is expected to begin by the end of the spring of 2019. The first interim analysis is planned for later this year.