Case Western Reserve University researchers have developed a drug known as Myeliviz that could make it easier for doctors to diagnose multiple sclerosis (MS) in its earlier stages. The Ohio-based team has secured $1.7 million from the NIH for an FDA-compliant first-in-human clinical trial to be tested on healthy volunteers at the Cleveland Clinic Mellen Center for Multiple Sclerosis.
The Health Challenge (MS)
Multiple sclerosis is an autoimmune disease affecting 2.3 million people worldwide reports the National Multiple Sclerosis Society (NMSS). As reported by Daniel Robison with The Daily Case, the disease can be particularly difficult to diagnose, especially in the early stages due to a number of factors. These include unpredictable combinations of symptoms and their severity, and because of limitations in other available imaging methods to name some.
MS is most often diagnosed between the ages of 20 and 50 according to NMSS and is not contagious or directly inherited.
What is Myeliviz?
Myeliviz is the first agent to be studied for myelin PET imaging in humans, and is, therefore, the first in the class of myelin PET agents to be studied in humans.
This drug targets and binds to myelin—the sheathing surrounding nerves that is affected by MS—and allows for its imaging by a PET scanner, a common hospital tool. This drug has the potential to offer a new source of evidence to help doctors determine the existence and extent of damage to the central nervous system (CNS) from MS. The drug’s co-inventor, Yanming Wang, is a professor of radiology at the School of Medicine at Case Western Reserve University. The other co-investor is Chunying Wu, an instructor at Case Western Reserve.
Wang noted 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.” Wang will serve as the co-principal investigator for the study made possible by a $1.7 million grant from the National Institutes of Health.
How does Myeliviz Work?
Administered by an IV prior to a PET scan, the experimental drug targets and binds to myelin—acting as a marker in PET images. Normal myelin and damaged myelin have different patterns of Myeliviz uptake, reports The Daily Case. Areas where myelin has been damaged appear as dark spots on the images, offering doctors with a potential new form of evidence to help determine MS diagnoses.
With the potential for earlier and more accurate diagnoses of the disease could help doctors use current treatments more effectively, such as during key early stages when the long-term severity of debilitating effects can be influenced.
The goal here is to determine if the combination of Myeliviz and PET imaging may be able to supplement, and perhaps in some cases replace, the use of magnetic resonance imaging (MRI) machines—which indirectly image myelin. The existing standard of care imaging examination for MS, MRIs have long been used for diagnosis but are less effective for monitoring the disease.
The Research Team
In addition to the two co-inventors, the team includes Junqing Zhu, Curtis Tatsuoka, David Wilson, and Jerry Silver of Case Western Reserve, Stephen Selkirk of the VA Northeast Ohio Healthcare System, and Bruce Trapp, Rebecca Algeri and colleagues at Cleveland Clinic.
The study seeks to help physicians be able to “more unambiguously diagnose MS and monitor disease progression and repair process,” reports Robert Fox, vice chair for research in Cleveland Clinic’s Neurological Institute and co-principal investigator of the grant. TrialSite News research wasn’t able to find this Phase I study listed in ClinicalTrials.gov as of yet.
Yanming Wang, professor of radiology, School of Medicine at Case Western Reserve, Co-investigator
Chunying Wu, Instructor, Case Western Reserve
Call to Action: Interested in learning more? Case Western’s formal contact is Daniel Robison, Assistant Director, Media Relations. We also include the co-inventors background information.