MND Scotland has initiated a clinical trial to test the tolerability and effectiveness of interleukin-2 in the treatment of amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND). The trial is now recruiting participants.
Interleukin-2, which is used for treatment of some rare types of cancer, is a molecule that regulates specific components of the immune system.
Specifically, interleukin-2 increases the production of special immune cells — regulatory T-Cells — that are thought to play an important role in controlling inflammation and protecting motor neurons. The increased production of regulatory T-Cells is then able to influence the speed at which the ALS progresses.
The clinical trial (NCT03039673) is titled Modifying Immune Response and Outcomes in Amyotrophic Lateral Sclerosis (MIROCALS) and will be conducted in around the United Kingdom and France. Estimated enrollment is 216 patients. Currently, the trial is recruiting patients in Glasgow, Scotland.
George Gorrie, MD, consultant neurologist at the Queen Elizabeth University Hospital, will lead the trial in Scotland, which will receive some of its funding from MND Scotland.
The chief trial investigator of MIROCALS, Nigel Leigh, MD, PhD, said in a press release, “This will be a tremendous help in reaching our recruitment target faster and thus being able to complete the whole study as soon as possible.”
Investigating the use of interleukin-2 as a treatment for ALS will help determine not only the therapeutic effectiveness of the treatment, but also shed some light on the disease mechanisms of ALS.
“Our main goal is to find a new treatment to slow down the progression of ALS, but this project will also deliver many new insights into the disease, and make a major contribution to improving future trials in ALS and other neurodegenerative disorders,” said Leigh.
In the past, MND Scotland has stated a commitment to provide more than £1.5m ($1.9 million U.S.) for MND drug trials in Scotland. MIROCALS represents its first investment into this foray.
Patients in the MIROCALS trial will be treated with either interleukin-2 or placebo in conjunction with riluzole (brand name Rilutek), which is part of routine care for patients with ALS. The primary outcome measure of the study is time to death from date of randomization to date of death.