A new drug has been shown to slow brain shrinkage in multiple sclerosis patients, according to a new preliminary trial conducted in part with the University of Iowa.
The study, published this week in the New England Journal of Medicine, tested a drug called ibudilast on individuals with progressive multiple sclerosis, a disease also commonly known as MS that affects the brain and central nervous system.
Of the 255 patients with progressive multiple sclerosis, the study found that ibudilast slowed brain atrophy — or brain shrinkage — by 48 percent compared with the patients who took a placebo over the course of 96 weeks, said Dr. Robert Fox, lead researcher on the study and staff neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic in Ohio.
“The patients treated with ibudilast had about 2.5 milliliters less of brain tissue loss or shrinkage compared to the placebo-treated patients,” Fox told The Gazette.
While there’s no clear clinical benefit at this stage, the study is what Fox described as a “proof of concept” trial, meaning it provided evidence that “this drug does slow something we think is important — shrinkage of the brain.”
The University of Iowa served as the data coordinating center for the study, collecting data captured across the 28 clinical sites that collected brain imaging scans of the study’s subjects. Researchers then integrated the information into a single database and conducted the statistical analysis for the report, said Christopher Coffey, UI professor and director of the Clinical Trials Statistical Data Management Center.
“The University of Iowa had critical roles in this project and was an ideal partner to carry this project forward,” Fox said.
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Coffey said the trial, which cost about $15 million, was funded mostly by the National Institutes of Health through its NeuroNEXT project, started in 2011 to conduct studies of neurological disease treatments.
The university’s data coordinating center is currently participating in seven other studies that fall under the NeuroNEXT project’s umbrella, Coffey said. The UI receives about $4 million a year from the National Institutes of Health to be a part of the NeuroNEXT project.
The recently released study on ibudilast points to a potential for new therapy for patients with progressive multiple sclerosis, who Fox said lack treatment options for the disease. He said those with relapsing-remitting multiple sclerosis have about a dozen therapies approved by the Food and Drug Administration.
“There’s a huge unmet need for therapies for progressive (multiple sclerosis),” Fox said.
The new step for the drug ibudilast would be another trial to demonstrate the clinical benefit to justify its FDA approval for widespread use. The next trial would require more patients and be more expensive — a price tag of about $103 million. However, Fox said California-based pharmaceutical company MediciNova in the process of starting a clinical trial.
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