GE HealthCare Announces Phase I Results for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent
GE HealthCare (Nasdaq: GEHC) has announced the completion of its Phase I clinical development program for a first-of-its-kind manganese-based macrocyclic MRI contrast agent. The results, presented at the 2024 bi-annual Contrast Media Research symposium in Oslo, Norway, showed that the agent was well tolerated with no serious adverse events or clinically relevant findings reported.
This novel contrast agent could provide an alternative to gadolinium-based agents, addressing concerns about gadolinium retention and environmental impact. The manganese-based agent has comparable relaxivity to gadolinium-based agents and is expected to be diagnostically similar. Unlike gadolinium, manganese is naturally occurring in and efficiently eliminated from the body.
The Phase I trial was conducted at Oslo University Hospital, Rikshospitalet, Norway, with partial funding from the Norwegian Research Council. GE HealthCare aims to offer more choice to radiologists and deliver a broad portfolio for personalized care and unmet patient needs.
GE HealthCare (Nasdaq: GEHC) ha annunciato il completamento del suo programma di sviluppo clinico di Fase I per un degno sostituto del primo contrasto a base di manganese per risonanza magnetica (MRI). I risultati, presentati al simposio biennale sul contrasto per la ricerca dei mezzi a Oslo, in Norvegia, hanno mostrato che il agente è stato ben tollerato senza eventi avversi gravi o risultati clinicamente rilevanti riportati.
Questo nuovo agente di contrasto potrebbe fornire un alternativa agli agenti a base di gadolinio, affrontando le preoccupazioni riguardo alla ritenzione di gadolinio e all'impatto ambientale. L'agente a base di manganese ha una relassività comparabile a quella degli agenti a base di gadolinio e si prevede che sia diagnostico in modo simile. A differenza del gadolinio, il manganese è presente in natura e viene eliminato in modo efficiente dall'organismo.
La sperimentazione di Fase I è stata condotta presso l'Ospedale Universitario di Oslo, Rikshospitalet, Norvegia, con un finanziamento parziale del Consiglio Norvegese della Ricerca. GE HealthCare mira a offrire più opzioni ai radiologi e a fornire un ampio portafoglio per cure personalizzate e bisogni insoddisfatti dei pazienti.
GE HealthCare (Nasdaq: GEHC) ha anunciado la finalización de su programa de desarrollo clínico de Fase I para un agente de contraste a base de manganeso, único en su tipo, para resonancia magnética (MRI). Los resultados, presentados en el simposio bienal de investigación de medios de contraste en Oslo, Noruega, mostraron que el agente fue bien tolerado sin eventos adversos graves ni hallazgos clínicamente relevantes reportados.
Este novedoso agente de contraste podría proporcionar una alternativa a los agentes a base de gadolinio, abordando preocupaciones sobre la retención de gadolinio y el impacto ambiental. El agente a base de manganeso tiene una relajación comparable a la de los agentes a base de gadolinio y se espera que sea diagnosticado de manera similar. A diferencia del gadolinio, el manganeso ocurre naturalmente y se elimina de manera eficiente del cuerpo.
El ensayo de Fase I se llevó a cabo en el Hospital Universitario de Oslo, Rikshospitalet, Noruega, con financiación parcial del Consejo Noruego de Investigación. GE HealthCare tiene como objetivo ofrecer más opciones a los radiólogos y proporcionar una amplia cartera para la atención personalizada y necesidades insatisfechas de los pacientes.
GE HealthCare (Nasdaq: GEHC)는 혁신적인 망간 기반 매크로사이클 MRI 조영제의 1상 임상 개발 프로그램의 완료를 발표했습니다. 노르웨이 오슬로에서 열린 2024년 반기 조영제 연구 심포지엄에서 발표된 결과는 심각한 부작용 없이 잘 내약성이 있으며 임상적으로 관련된 발견이 보고되지 않았음을 보여주었습니다.
이 새로운 조영제는 가돌리늄 기반 조영제의 대안을 제공할 수 있어, 가돌리늄 축적과 환경 영향에 대한 우려를 다루고 있습니다. 망간 기반 조영제는 가돌리늄 기반 조영제와 비슷한 이완도를 가지고 있으며 진단적으로 유사할 것으로 예상됩니다. 가돌리늄과 달리, 망간은 자연적으로 존재하고 체내에서 효율적으로 제거됩니다.
1상 시험은 노르웨이 오슬로 대학병원 리크스병원에서 수행되었으며, 노르웨이 연구위원회의 부분적인 자금을 지원받았습니다. GE HealthCare는 방사선 전문의에게 더 많은 선택권을 제공하고 개인화된 치료 및 환자의 unmet needs를 위한 폭넓은 포트폴리오를 제공하는 것을 목표로 하고 있습니다.
GE HealthCare (Nasdaq: GEHC) a annoncé l'achèvement de son programme de développement clinique de Phase I pour un agent de contraste par IRM à base de manganèse, inédit en son genre. Les résultats présentés lors du symposium de recherche biennal sur les agents de contraste 2024 à Oslo, en Norvège, ont montré que cet agent était bien toléré, sans événements indésirables graves ni résultats cliniquement pertinents signalés.
Ce nouvel agent de contraste pourrait fournir une alternative aux agents à base de gadolinium, en répondant aux préoccupations concernant la rétention de gadolinium et l'impact environnemental. L'agent à base de manganèse présente une relaxation comparable à celle des agents à base de gadolinium et devrait être diagnostiquement similaire. Contrairement au gadolinium, le manganèse est naturellement présent dans le corps et est éliminé efficacement.
L'essai de Phase I a été réalisé à l'Hôpital Universitaire d'Oslo, Rikshospitalet, en Norvège, avec un financement partiel du Conseil Norvégien de la Recherche. GE HealthCare vise à offrir davantage de choix aux radiologues et à fournir un large portefeuille pour des soins personnalisés et des besoins non satisfaits des patients.
GE HealthCare (Nasdaq: GEHC) hat den Abschluss seines klinischen Entwicklungsprogramms der Phase I für ein erstmaliges manganbasiertes makrozyklisches MRT-Kontrastmittel bekannt gegeben. Die Ergebnisse, die auf dem 2024 biennalen Symposium zur Forschung über Kontrastmittel in Oslo, Norwegen, präsentiert wurden, zeigten, dass der Wirkstoff gut vertragen wurde, ohne dass schwerwiegende unerwünschte Ereignisse oder klinisch relevante Befunde gemeldet wurden.
Dieses neuartige Kontrastmittel könnte eine Alternative zu gadoliniumhaltigen Mitteln bieten, da es Bedenken hinsichtlich der Gadolinium-Retention und der Umweltbelastung anspricht. Das manganbasierte Mittel hat eine vergleichbare Relaxation zu gadoliniumhaltigen Mitteln und wird voraussichtlich diagnostisch ähnlich sein. Im Gegensatz zu Gadolinium kommt Mangan natürlich vor und wird effizient aus dem Körper ausgeschieden.
Die Phase-I-Studie wurde am Oslo Universitätskrankenhaus, Rikshospitalet, Norwegen, mit teilweise finanzieller Unterstützung des Norwegischen Forschungsrats durchgeführt. GE HealthCare zielt darauf ab, Radiologen mehr Wahlmöglichkeiten zu bieten und ein breites Portfolio für personalisierte Pflege und unerfüllte Patientenbedürfnisse anzubieten.
- Successful completion of Phase I clinical trial for a novel manganese-based MRI contrast agent
- The contrast agent was well tolerated with no serious adverse events reported
- Potential alternative to gadolinium-based agents, addressing safety and environmental concerns
- Comparable relaxivity to gadolinium-based agents, expected to be diagnostically similar
- None.
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Results of the Phase I clinical trial, presented at the bi-annual Contrast Media Research symposium in
Oslo, Norway , conclude that this novel macrocyclic manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported. - If approved, this agent could provide an alternative to gadolinium-based contrast agents and address the potential impact of post-patient excreted gadolinium in the environment.
- The clinical trial program demonstrates GE HealthCare’s commitment to innovation in contrast media and to building a portfolio of MRI imaging agents to address radiologists’ needs for their patients.
CHALFONT ST GILES,
A radiologist looking at MRI exam images (Photo: Business Wire)
MRI contrast agents, which are typically gadolinium-based, are used to enhance visualization of abnormal structures or lesions and to aid differentiation between healthy and pathological tissue. This macrocyclic, extra-cellular, general-purpose, manganese-based contrast agent has comparable relaxivity (the ability to enhance signal intensity) to gadolinium-based agents and is expected to be diagnostically similar to current gadolinium-based products. Unlike gadolinium, manganese is naturally occurring in - and efficiently eliminated - from the body. Along with its suitable image-enhancing properties, this manganese-based agent could be a viable alternative to gadolinium, particularly in light of perceived concerns relating to gadolinium retention and the potential impact of post-patient excreted gadolinium in the environment.
Dr Paul Evans, Head of Global R&D at GE HealthCare’s Pharmaceutical Diagnostics business segment, said, “These are encouraging Phase I results for this manganese-based contrast agent and we look forward to completing the next steps in the clinical development process. This is part of our pipeline of products aiming to improve patient outcomes across care pathways.”
Dr Robert J. McDonald, Radiologist at Mayo Clinic and Contrast Media Safety Committee Board member for the American College of Radiology, whose group has collaborated with GE HealthCare during the research phase, commented, “GE HealthCare’s manganese-based contrast agent could offer benefits such as reduced risk of tissue deposition and improved safety for certain vulnerable patient populations compared to gadolinium-based agents, while also providing comparable imaging capabilities and potentially lower environmental impact.”
The Phase I trial was undertaken at the clinical research unit at Oslo University Hospital, Rikshospitalet,
Kevin O’Neill, President and CEO of GE HealthCare’s Pharmaceutical Diagnostics segment, added, “As we celebrate milestone anniversaries for these two facilities, the Phase I results are a reminder of Norway’s heritage of innovation that has shaped the field of diagnostic imaging, improving patient outcomes worldwide. We aim to offer more choice to radiologists, delivering a broad portfolio that can enable personalized care and address unmet patient needs.”
GE HealthCare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support 120 million procedures per year globally, equivalent to four patient procedures every second. For more than 40 years, GE HealthCare contrast media has been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a
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Source: GE HealthCare
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