Quantum BioPharma Ltd. has achieved a significant milestone in multiple sclerosis research by successfully scanning the first patient with MS using a novel positron emission tomography (PET) imaging technique in collaboration with Massachusetts General Hospital scientists. The study aims to validate [18F]3F4AP as a biomarker for monitoring myelin integrity and demyelination in people with multiple sclerosis.
Revolutionary PET-MR Technology Integration
The breakthrough scan was performed using a newly installed combined GE Signa PET-MR scanner at MGH, which represents a significant technological advancement in neuroimaging. This state-of-the-art equipment allows for simultaneous acquisition of PET [18F]3F4AP imaging signals with MRI, improving both spatial and temporal coregistration of the imaging data. The combined approach also enhances the patient experience by reducing the total time needed to complete both scans.
Dr. Pedro Brugarolas, the principal investigator in MGH's department of Radiology and Assistant Professor at Harvard Medical School, developed the [18F]3F4AP PET tracer. "PET/MR studies are complex and the team at the MGH PET Core has been phenomenal. By employing the latest technologies, we hope to learn more about how [18F]3F4AP PET can enhance MRI for monitoring demyelination and, by doing so, facilitate the development of novel treatments for people with MS," Dr. Brugarolas stated.
Promising Preclinical and Clinical Evidence
The [18F]3F4AP tracer has demonstrated exceptional promise in previous research studies. In animal studies conducted in rodents and monkeys, [18F]3F4AP showed high sensitivity to demyelinated lesions. Additionally, studies in both animals and humans revealed favorable pharmacokinetics, suggesting the tracer's potential as an effective biomarker for monitoring changes in demyelination in response to remyelinating or neuroprotective drugs in MS.
The radiotracer is a radiolabeled form of the drug dalfampridine, which binds to K+ channels in demyelinated axons. This mechanism allows researchers to identify and monitor patients who respond to remyelinating and neuroprotective treatments for MS.
Clinical Study Design and Objectives
The clinical study, entitled "Preliminary Evaluation of [18F]3F4AP PET as a potential tool to monitor non-immunomodulatory drugs in multiple sclerosis," involves serial [18F]3F4AP PET scans performed alongside magnetic resonance imaging (MRI) scans in people with both progressive and relapsing-remitting forms of MS. Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and Associate Professor of Neurology at Harvard Medical School, serves as co-investigator.
The study's primary goal is to validate whether PET imaging with [18F]3F4AP can complement MRI imaging by providing an ultra-sensitive and quantitative assessment of demyelination. This novel biomarker technique may lead to more accurate measurement of responses to drugs that prevent demyelination and promote remyelination in the central nervous system.
Implications for Drug Development
Dr. Andrzej Chruscinski, Vice-President of Scientific and Clinical Affairs at Quantum BioPharma, emphasized the significance of this development: "We are excited that the study has started and that we are learning more about the potential of this novel PET biomarker to directly visualize and measure demyelinated axons in the central nervous system. PET imaging with [18F]3F4AP holds promise as a biomarker to measure the efficacy of drugs that can protect the myelin sheath in MS such as Lucid-21-302 (Lucid-MS)."
The imaging technique is particularly relevant to Quantum BioPharma's Lucid-MS clinical development program. Lucid-MS, the company's lead compound, is a patented new chemical entity that has been shown to prevent and reverse myelin degradation in preclinical models of MS. The company expects that this biomarker will serve as an important diagnostic tool in future MS trials investigating therapies that can prevent demyelination and promote remyelination.
Strategic Partnership and Future Outlook
The collaboration between Quantum BioPharma and Massachusetts General Hospital represents a strategic partnership combining pharmaceutical development expertise with leading academic medical research capabilities. Zeeshan Saeed, CEO of Quantum BioPharma, expressed enthusiasm about the partnership: "We are glad to be part of this study and working with this team of scientists and physicians at Mass General in developing this PET tracer as a biomarker in MS."
The successful completion of the first patient scan marks a crucial step forward in validating this novel imaging approach. As the study progresses with additional patients, researchers will gather critical data on the tracer's effectiveness in monitoring demyelination processes and its potential utility in evaluating therapeutic interventions for multiple sclerosis.
