GE Healthcare and Lantheus Phase III Clinical Trial Finds [18F]flurpiridaz PET Radiotracer Could Improve Detection of Coronary Artery Disease
2022年9月13日 - 9:05PM
ビジネスワイヤ(英語)
- Phase III clinical trial of [18F]flurpiridaz PET diagnostic
radiopharmaceutical meets co-primary endpoints for detecting
Coronary Artery Disease (CAD)
- Trial also met its first key secondary endpoint, demonstrating
higher diagnostic efficacy for [18F]flurpiridaz PET compared to
SPECT Myocardial Perfusion Imaging (MPI)
- With a half-life roughly 12 times longer than currently
approved cardiac PET radiotracers, if approved, [18F]flurpiridaz
has the potential to expand patient access to PET MPI
- This radiotracer is part of GE Healthcare’s pipeline of
Molecular Imaging diagnostics aiming to increase diagnostic
accuracy and improve patient outcomes across key care areas
GE Healthcare and Lantheus Holdings Inc (NASDAQ: LNTH) have
announced that the recent Phase III clinical trial of their
investigational radiotracer, [18F]flurpiridaz, has met its
co-primary endpoints of exceeding a 60 percent threshold for both
sensitivity and specificity for detecting Coronary Artery Disease
(CAD). The findings, shared at the American Society of Nuclear
Cardiology (ASNC) Congress, in Florida, U.S., also demonstrate
[18F]flurpiridaz Positron Emission Tomography (PET) has higher
diagnostic efficacy and image quality in patients with suspected
CAD, compared with Single Photon Emission Computed Tomography
(SPECT) Myocardial Perfusion Imaging (MPI), the predominant
procedure used in nuclear cardiology today. SPECT MPI represents
approximately 6 million procedures per year in the U.Si.
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The Phase III Open-Label Study, which involved over 600 patients
across sites in the U.S., Europe and Canada assessed the diagnostic
efficacy of [18F]flurpiridaz in detecting CAD, the most common form
of heart diseaseii and the leading cause of death globallyiii, with
invasive coronary angiography as a standard of truth. More than 120
million people are affected by CAD globally each yeariv and in the
U.S. alone, approximately 20 million adults have CAD, with nearly
383,000 deaths recorded in 2020v.
If approved, this investigational agent would offer the
advantages of 18F, with broad available distribution and a
half-life of almost two hours, removing the need for it to be
manufactured in the immediate vicinity of the imaging department.
This longer half-life could also make Flurpiridaz (18F) Injection
suitable for exercise stress testing, which is not feasible with
existing cardiac PET radiotracers.
Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular
Radiologic Imaging Program at Saint Luke's Hospital, Missouri, US,
shared: “These results are truly promising for the nuclear
cardiology community and CAD patients. From ASNC’s inception, its
leaders have laid out the specifications for an ideal myocardial
perfusion tracer. In my view [18F]flurpiridaz could meet this goal,
expanding how PET MPI can be used to image CAD patients moving
forward.”
Dr. Francois Tranquart, MD, PhD, Global Head of Clinical
Development for GE Healthcare Pharmaceutical Diagnostics, Research
and Development, said: “The positive Phase III trial results are a
key step towards future approval of Flurpiridaz (18F) Injection as
a potential new cardiac PET agent which could improve the detection
of coronary artery disease. This is another example of GE
Healthcare investing in our portfolio of Molecular Imaging products
to help improve diagnostic accuracy and patient outcomes.”
GE Healthcare has led the funding and development of
[18F]flurpiridaz, and, if the imaging agent is approved, will have
global commercialization rights. Lantheus has collaborated on the
development and will also collaborate on potential
commercialization through a joint steering committee. Lantheus is
entitled to royalties based on commercial sales.
GE Healthcare’s Pharmaceutical Diagnostics unit is a global
leader in imaging agents used to support around 100 million
procedures per year globally, equivalent to three patients every
second. Its Molecular Imaging portfolio combines an innovative
pipeline with established proprietary products across cardiology,
neurology and oncology.
About GE Healthcare:
GE Healthcare is the $17.7 billion healthcare business of GE
(NYSE: GE). As a leading global medical technology, pharmaceutical
diagnostics and digital solutions innovator, GE Healthcare enables
clinicians to make faster, more informed decisions through
intelligent devices, data analytics, applications and services,
supported by its Edison intelligence platform. With over 100 years
of healthcare industry experience and around 48,000 employees
globally, the company operates at the center of an ecosystem
working toward precision health, digitizing healthcare, helping
drive productivity and improve outcomes for patients, providers,
health systems and researchers around the world.
Follow us on Facebook, LinkedIn, Twitter, and Insights for the
latest news, or visit our website www.gehealthcare.com for more
information.
About Lantheus
With more than 60 years of experience in delivering
life-changing science, Lantheus is committed to improving patient
outcomes through diagnostics, radiotherapeutics and artificial
intelligence solutions that enable clinicians to Find, Fight and
Follow disease. Lantheus is headquartered in Massachusetts and has
offices in New Jersey, Canada and Sweden. For more information,
visit www.lantheus.com.
###
i Data on File: AMR Market Guide 2021.
ii WHO Factsheet 2020. Cardiovascular diseases (CVDs). 11 June
2021.
iii Global Epidemiology of Ischemic Heart Disease: Results from
the Global Burden of Disease Study. July 23 2020.
iv Global Epidemiology of Ischemic Heart Disease: Results from
the Global Burden of Disease Study. July 23 2020.
v Centers for Disease Control and Prevention. Heart Disease
Facts. Accessed July 15 2022.
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GE Healthcare Media Contact: Debbie Leven
Debbie.Leven@ge.com +44 7785 456999 Lantheus Contacts:
Investors Mark Kinarney Vice President, Investor Relations
978-671-8842 ir@lantheus.com Media Melissa Downs Senior
Director, Corporate Communications 646-975-2533
media@lantheus.com
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