GE HealthCare Announces Phase I Results for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent
2024年10月7日 - 3:30PM
ビジネスワイヤ(英語)
- 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.
GE HealthCare (Nasdaq: GEHC) has today announced the completion
of its Phase I clinical development program for a first-of-its-kind
manganese-based macrocyclic magnetic resonance imaging (MRI)
contrast agent. The results, which will be used to support ongoing
clinical development, concluded that in a first-in-human study,
this manganese-based contrast agent was well tolerated with no
serious adverse events, dose-limiting toxicities or clinically
relevant findings reported, according to an abstract presented at
the 2024 bi-annual Contrast Media Research symposium in Oslo,
Norway.
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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, Norway, and benefited
from partial funding provided by the Norwegian Research Council. GE
HealthCare has two contrast media facilities in Norway. One site in
Oslo, where this manganese-based contrast agent was developed, is
celebrating its 150-year anniversary this year. In addition, GE
HealthCare’s active pharmaceutical ingredients (API) manufacturing
site in Lindesnes, southern Norway, is celebrating its 50th year of
production.
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 $19.6 billion
business with approximately 51,000 colleagues working to create a
world where healthcare has no limits.
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GE HealthCare Media Contact: Mathilde Bouscaillou M +33 6
47 00 82 71 mathilde.bouscaillou@gehealthcare.com
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