New drug that could aid earlier MS diagnoses approved by FDA for first human clinical trials

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New drug that could aid earlier MS diagnoses approved by FDA for first human clinical trials

Press releases may be edited for formatting or style | January 29, 2020 Alzheimers/Neurology Molecular Imaging

“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,” said Chunying Wu, the drug’s co-inventor and instructor of radiology at Case Western Reserve.

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 current standard-of-care imaging examination for MS, MRIs have long been used for diagnoses but are less effective for monitoring the disease.

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“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,” said Mykol Larvie, director of functional neuroimaging at Cleveland Clinic, who leads efforts on the FDA application process.

MS is most often diagnosed between the ages of 20 and 50, according to the NMSS; MS is not contagious or directly inherited.

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.

The research team also 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.

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