Quantum BioPharma Announces Joint Clinical Study With Massachusetts General Hospital Scientists to Validate a Novel Positron Emission Tomography (PET) Imaging Technique to Monitor Demyelination In Multiple Sclerosis
Quantum BioPharma (NASDAQ: QNTM) has partnered with Massachusetts General Hospital (MGH) for a joint clinical study to validate a novel PET imaging technique for monitoring myelin integrity and demyelination in multiple sclerosis (MS) patients.
The study, led by Dr. Pedro Brugarolas and co-investigated by Dr. Eric Klawiter, will evaluate [18F]3F4AP PET scans alongside MRI scans in both progressive and relapsing-remitting MS forms. Previous studies in rodents and monkeys showed [18F]3F4AP's high sensitivity to demyelinated lesions, suggesting its potential as a biomarker for monitoring demyelination changes in response to MS treatments.
This PET imaging technique, using a radiolabeled form of dalfampridine, aims to complement MRI by providing ultra-sensitive and quantitative demyelination assessment. The research is particularly relevant to Quantum's Lucid-MS clinical development program, which has demonstrated myelin sheath protection in animal models.
Quantum BioPharma (NASDAQ: QNTM) ha stretto una collaborazione con il Massachusetts General Hospital (MGH) per uno studio clinico congiunto volto a convalidare una nuova tecnica di imaging PET per monitorare l'integrità della mielina e la demielinizzazione nei pazienti affetti da sclerosi multipla (SM).
Lo studio, guidato dal Dr. Pedro Brugarolas e co-condotto dal Dr. Eric Klawiter, valuterà le scansioni PET [18F]3F4AP insieme alle scansioni MRI sia nelle forme progressive che in quelle a ricaduta della SM. Studi precedenti su roditori e scimmie hanno mostrato l'alta sensibilità di [18F]3F4AP per le lesioni demielinizzate, suggerendo il suo potenziale come biomarker per monitorare i cambiamenti nella demielinizzazione in risposta ai trattamenti per la SM.
Questa tecnica di imaging PET, che utilizza una forma radioattiva di dalfampridina, mira a integrare la MRI fornendo una valutazione della demielinizzazione ultra-sensibile e quantitativa. La ricerca è particolarmente rilevante per il programma di sviluppo clinico Lucid-MS di Quantum, che ha dimostrato di proteggere la guaina mielinica in modelli animali.
Quantum BioPharma (NASDAQ: QNTM) se ha asociado con el Massachusetts General Hospital (MGH) para un estudio clínico conjunto que valida una nueva técnica de imagen PET para monitorear la integridad de la mielina y la desmielinización en pacientes con esclerosis múltiple (EM).
El estudio, dirigido por el Dr. Pedro Brugarolas y co-investigado por el Dr. Eric Klawiter, evaluará las exploraciones PET [18F]3F4AP junto con las exploraciones de MRI en ambas formas de EM: progresiva y recurrente-remitente. Estudios previos en roedores y monos mostraron la alta sensibilidad de [18F]3F4AP a las lesiones desmielinizadas, sugiriendo su potencial como biomarcador para monitorear los cambios en la desmielinización en respuesta a los tratamientos para la EM.
Esta técnica de imagen PET, que utiliza una forma radiomarcada de dalfampridina, busca complementar la MRI proporcionando una evaluación ultra-sensible y cuantitativa de la desmielinización. La investigación es particularmente relevante para el programa de desarrollo clínico Lucid-MS de Quantum, que ha demostrado proteger la vaina de mielina en modelos animales.
Quantum BioPharma (NASDAQ: QNTM)는 매사추세츠 종합병원(MGH)과 협력하여 다발성 경화증(MS) 환자의 미엘린 무결성과 탈수초화를 모니터링하기 위한 새로운 PET 이미징 기법을 검증하는 공동 임상 연구를 진행하고 있습니다.
이 연구는 페드로 브루가롤라스 박사가 이끌고 에릭 클라위터 박사가 공동 연구자로 참여하며, 진행형 및 재발-완화형 MS 형태에서 [18F]3F4AP PET 스캔과 MRI 스캔을 평가할 것입니다. 이전의 쥐와 원숭이에 대한 연구에서는 [18F]3F4AP가 탈수초화된 병변에 대해 높은 민감도를 보여, MS 치료에 대한 반응으로 탈수초화 변화 모니터링을 위한 바이오마커로서의 잠재력을 시사했습니다.
이 PET 이미징 기법은 달팡프리딘의 방사성 형태를 사용하여 MRI를 보완하고 탈수초화를 초민감하고 정량적으로 평가하는 것을 목표로 하고 있습니다. 이 연구는 동물 모델에서 미엘린 수초 보호를 입증한 Quantum의 Lucid-MS 임상 개발 프로그램과 특히 관련이 있습니다.
Quantum BioPharma (NASDAQ: QNTM) s'est associé à l'hôpital général du Massachusetts (MGH) pour une étude clinique conjointe visant à valider une nouvelle technique d'imagerie PET pour surveiller l'intégrité de la myéline et la démyélinisation chez les patients atteints de sclérose en plaques (SEP).
L'étude, dirigée par le Dr Pedro Brugarolas et co-étudiée par le Dr Eric Klawiter, évaluera les scans PET [18F]3F4AP en parallèle avec les scans IRM dans les formes de SEP progressive et récurrente-rémittente. Des études antérieures sur des rongeurs et des singes ont montré la haute sensibilité de [18F]3F4AP aux lésions démyélinisées, suggérant son potentiel en tant que biomarqueur pour surveiller les changements de démyélinisation en réponse aux traitements de la SEP.
Cette technique d'imagerie PET, utilisant une forme radiomarquée de dalfampridine, vise à compléter l'IRM en fournissant une évaluation ultra-sensible et quantitative de la démyélinisation. La recherche est particulièrement pertinente pour le programme de développement clinique Lucid-MS de Quantum, qui a démontré une protection de la gaine de myéline dans des modèles animaux.
Quantum BioPharma (NASDAQ: QNTM) hat sich mit dem Massachusetts General Hospital (MGH) zusammengetan, um eine gemeinsame klinische Studie durchzuführen, die eine neuartige PET-Bildgebungstechnik zur Überwachung der Myelinintegrität und Demyelinisierung bei Patienten mit Multipler Sklerose (MS) validiert.
Die Studie, die von Dr. Pedro Brugarolas geleitet und von Dr. Eric Klawiter mituntersucht wird, wird [18F]3F4AP PET-Scans zusammen mit MRI-Scans in beiden MS-Formen, der progressiven und der schubförmigen, bewerten. Frühere Studien an Nagetieren und Affen zeigten die hohe Sensitivität von [18F]3F4AP gegenüber demyelinierten Läsionen, was auf sein Potenzial als Biomarker zur Überwachung von Demyelinisierungsänderungen als Reaktion auf MS-Behandlungen hinweist.
Diese PET-Bildgebungstechnik, die eine radioaktive Form von Dalfampridin verwendet, zielt darauf ab, die MRI zu ergänzen, indem sie eine ultrasensible und quantitative Bewertung der Demyelinisierung bereitstellt. Die Forschung ist besonders relevant für Quantums klinisches Entwicklungsprogramm Lucid-MS, das den Schutz der Myelinschicht in Tiermodellen nachgewiesen hat.
- Partnership with prestigious Massachusetts General Hospital enhances research credibility
- Novel PET imaging technique shows promising results in animal studies
- Technology complements existing MRI imaging with ultra-sensitive quantitative assessment
- Alignment with existing Lucid-MS program demonstrates strategic development approach
- Early-stage research with unproven clinical efficacy in humans
- Results from animal studies may not translate to human applications
Insights
Quantum BioPharma's partnership with Massachusetts General Hospital represents a strategic but early-stage research initiative that could potentially enhance their MS pipeline capabilities. The collaboration focuses on validating a novel PET imaging technique using [18F]3F4AP as a biomarker to monitor myelin integrity and demyelination in MS patients.
This research initiative has clear strategic alignment with Quantum's Lucid-MS clinical development program, which the company indicates has shown myelin-protective properties in preclinical models. The development of more sensitive biomarkers for demyelination could provide Quantum with significant advantages in evaluating treatment efficacy in future MS clinical trials.
For a small-cap biotech (
This collaboration appears methodologically sound, leveraging a radiolabeled form of dalfampridine (an already approved MS drug) to potentially create a more sensitive measurement tool than standard MRI. If successful, this imaging approach could become an important companion diagnostic for evaluating MS therapeutics that target demyelination processes.
The technical approach behind this PET imaging validation study addresses a significant unmet need in MS clinical assessment. Current MRI techniques, while valuable, have limitations in quantitatively measuring demyelination and remyelination processes that are central to MS pathology.
The [18F]3F4AP tracer represents an interesting scientific approach as it's derived from dalfampridine (4-aminopyridine), which binds to potassium channels that become exposed in demyelinated axons. This mechanism provides a direct functional measurement of demyelination rather than just structural imaging.
The inclusion of both progressive and relapsing-remitting MS patients in this study is methodologically important, as biomarker sensitivity may vary across disease subtypes. Previous positive results in animal models (rodents and non-human primates) provide reasonable preclinical validation, though human translation remains to be demonstrated.
If validated, this imaging technique could significantly impact MS clinical trials by providing more sensitive and quantitative endpoints for remyelinating and neuroprotective therapies. This represents a potential advancement in MS precision medicine, potentially helping identify which patients might respond to specific treatments targeting myelin protection or regeneration – directly relevant to Quantum's therapeutic interests.
TORONTO, April 01, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) “Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, announces that on March 31, 2025 it has entered into a joint clinical study with Massachusetts General Hospital (MGH) scientists to validate a novel positron emission tomography (PET) imaging technique to monitor myelin integrity and demyelination in people with multiple sclerosis (MS).
Dr. Pedro Brugarolas, investigator in the department of Radiology at MGH and Assistant Professor of Radiology at Harvard Medical School, is the principal investigator of the clinical study entitled “Preliminary Evaluation of [18F]3F4AP PET as a potential tool to monitor non-immunomodulatory drugs in multiple sclerosis.” Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and Associate Professor of Neurology at Harvard Medical School, will serve as co-investigator. In the clinical study, serial [18F]3F4AP PET scans will be performed along with magnetic resonance imaging (MRI) scans in people with both progressive and relapsing-remitting forms of MS. In previous studies in rodents and monkeys, [18F]3F4AP was highly sensitive to demyelinated lesions, suggesting that it holds promise as a biomarker to monitor changes in demyelination in response to remyelinating or neuroprotective drugs in MS. PET imaging with [18F]3F4AP may thus complement MRI imaging by providing an ultra-sensitive and quantitative assessment of demyelination.
“We are very excited about the potential of this novel PET biomarker to directly visualize and measure demyelination in the central nervous system”, said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. “We expect that this biomarker will be an important diagnostic tool in future MS trials investigating therapies that can prevent demyelination and promote remyelination. This is very relevant to our Lucid-MS clinical development program as Lucid-MS has been shown to protect the myelin sheath and prevent demyelination in animal models of MS.”
Zeeshan Saeed, CEO of Quantum BioPharma, added, “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.”
Dr. Brugarolas added, "[18F]3F4AP is a radiolabeled form of the drug dalfampridine which binds to K+ channels in demyelinated axons. As such we are interested to study its potential as a biomarker to identify and monitor responders to remyelinating and neuroprotective treatments for MS and we are excited to undertake this important work with Quantum BioPharma”.
About Quantum BioPharma Ltd.
Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented UNBUZZD™ and spun out its OTC version to a company, Celly Nutrition Corp. (“Celly Nutrition”), led by industry veterans. Quantum BioPharma retains ownership of
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Contacts:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (833) 571-1811
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FAQ
What is the purpose of Quantum BioPharma's (QNTM) new clinical study with MGH?
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