FDA approves clinical trial for ‘missing link’ imaging agent aimed at faster MS diagnosis

Case Western Reserve University scientists recently scored approval from the Food and Drug Administration to begin human trials using a new PET imaging agent.

Myeliviz, as the drug is called, is administered by IV prior to a scan, and could allow clinicians to more easily diagnose and track multiple sclerosis. The agent works by binding to the myelin, helping radiologists to determine early on whether such sheaths around the nerve fibers may be damaged.

Co-inventor Chunying Wu, PhD, a radiology instructor at Case Western, believes the drug could be a “missing link in finding a cure for MS and other myelin diseases.”

“Myelin has never been directly imaged before. Our technique is the first to do so, and we are hopeful that this will provide earlier and more accurate diagnosis of MS,” added Yanming Wang, PhD, the other inventor and also a professor of radiology at the Cleveland-based university’s School of Medicine.

Following the FDA's decision, clinicians will begin testing the drug in human clinical trials at the Cleveland Clinic Mellen Center for Multiple Sclerosis. Their work is fueled by a $1.7 million grant from the National Institutes of Health, according to an announcement.

MS currently affects about 2.3 million individuals across the globe, but the autoimmune disease can prove difficult to diagnose, especially for those in the early stages. That’s because of unpredictable combinations of symptoms and their severity, along with limitations in imaging methods, the team noted.

Magnetic resonance is the standard imaging method used to pinpoint MS. However, MRI indirectly images the myelin and can prove less effective for monitoring the disease, Wang and colleagues noted. They hope that PET combined with Myeliviz could eventually supplement or possibly replace MRI as the standard of care.

With multiple sclerosis often damaging the central nervous system before any visible symptoms surface, doctors hope the drug will eventually allow for earlier treatment, before it becomes debilitating. Myeliviz could also prove to be a game changer in addressing other diseases.

“This drug may provide improved ongoing monitoring of brain health in general—and help doctors more accurately gauge the effectiveness of treatments in numerous neurological diseases such as epilepsy, stroke, neurodegeneration, tumor and trauma in the brain and spinal cord,” added Mykol Larvie, MD, director of functional neuroimaging at Cleveland Clinic, who spearheaded the FDA application process.

Editor's Note: This article has been revised from a previous version to clarify that Myeliviz has been approved for human trials, not regular clinical use.