A new drug, which researchers will soon start testing in humans, could help doctors diagnose multiple sclerosis (MS) — and identify the stage of its progression — with more accuracy.
MS is a currently incurable condition that affects the central nervous system. Its symptoms, which can include muscle stiffness, uncontrolled movements, and problems with balance, among other issues, can become disabling.
While it is unclear just how many people live with MS, estimates from the National Institute of Neurological Disorders and Stroke suggest that around 250,000–350,000 individuals in the United States alone have a diagnosis of this condition.
Despite the fact that MS affects so many people in the U.S. and elsewhere and that it can lead to disability and decreased quality of life, doctors often encounter difficulties in diagnosing it and pinpointing the extent to which it has affected the nervous system.
Soon, however, this situation could change, thanks to a new diagnostic drug developed by researchers from Case Western Reserve University, in Cleveland, OH.
The team, co-led by Prof. Yanming Wang, created a drug — “Myeliviz” — that can bind to myelin, the coating that protects nerves, helping them function correctly.
In MS, myelin becomes damaged. As a result, the nerves also sustain some damage and stop working effectively, leading to the various symptoms of the condition.
Prof. Wang and his colleagues believe that, after administering Myeliviz, they will be able to use a PET scanner to track the drug’s presence in the nerves and establish accurate images of the damage to the myelin and the nerves within.
The researchers have now announced that they have received approval from the Food and Drug Administration (FDA) to start clinical trials in humans and test the effectiveness of Myeliviz as a tool for diagnosing MS.
They also explain that they have received funding — a $1.7 million grant —from the National Institutes of Health (NIH) to support these upcoming clinical trials.
“Myelin has never been directly imaged before,” Prof. Wang points out. “Our technique is the first to do so, and we are hopeful that this will provide earlier and more accurate diagnosis of MS,” he adds.
“The goal is to enable clinicians to more unambiguously diagnose MS and monitor disease progression and repair processes.”
– Co-principal investigator Dr. Robert Fox
The researchers explain that they will administer the drug intravenously — using an IV — and then perform PET scans.
If the myelin has sustained any damage, the team believes that this will be reflected as dark spots on the scan because, in this case, Myeliviz will only have been able to bind unevenly to the remaining myelin.
Recognizing this damage will help doctors diagnose MS early on, since, the team notes, the condition starts attacking the central nervous system before producing visible symptoms.
Using the new drug could also allow doctors to determine the extent of the damage to the person’s nervous system and prescribe more appropriate treatments.
“Myeliviz could be the missing link in finding a cure for MS and other myelin diseases by serving as a specific and quantitative imaging marker for early diagnosis and sensitive, quantitative evaluation of novel therapies currently under development,” says Chunying Wu, Ph.D., who codeveloped the drug.
The researchers also suggest that using Myeliviz and PET scans could replace MRI scans in diagnosing MS.
MRI scans are currently the go-to diagnostic tool, and they can indirectly image myelin. Yet, the team notes, these scans are not very useful in helping doctors monitor the condition’s progression.
And specialists are hopeful that the new method could be useful, not just in diagnosing and monitoring MS, but also in supporting brain health more broadly.
“[Myeliviz] 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,” comments Dr. Mykol Larvie, who is the director of functional neuroimaging at Cleveland Clinic and who spearheaded the FDA application process.