Findings Show LMI 1195 Provides a Comparable
Measure of Cardiac Sympathetic Nerve Function as PET imaging with
C11 HED
Lantheus Holdings, Inc. (NASDAQ: LNTH), the parent company of
Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the
development, manufacture and commercialization of innovative
diagnostic imaging agents, today announced positive new data from a
Phase 2 study of LMI 1195, a fluorine-18 (F18) labeled tracer for
use in cardiac positron emission tomography (PET) to assess
myocardial presynaptic sympathetic nerve function. Altered
sympathetic nervous system (SNS) function has been implicated in a
broad range of clinical conditions including heart failure and
sudden death. The data will be presented during a poster
presentation at the American College of Cardiology’s 67th Annual
Scientific Session (ACC.18) on Monday, March 12, 2018 at 9:45 a.m.
ET in the Noninvasive Imaging Moderated Poster Theater.
The data show that PET imaging with LMI 1195 provides a
comparable measure of cardiac sympathetic nerve function and more
favorable kinetics for early cardiac imaging as PET imaging with
carbon-11 (C11) hydroxyephedrine (HED). C11 HED has been used in
cardiac PET imaging to characterize SNS integrity and risk-stratify
patients with ischemic cardiomyopathy considered for implantable
cardiac defibrillators (ICD). However, widespread clinical utility
is limited due to the short half-life of C11-labeled tracers, which
require the onsite availability of a cyclotron.
“The Phase 2 study findings are encouraging and show the
comparability of PET imaging with LMI 1195 and C11 HED in a variety
of relevant cardiac conditions, including patients with ischemic
cardiomyopathy at risk for sudden cardiac arrest,” said Rob
Beanlands, M.D., Head, Division of Cardiology, University of Ottawa
Heart Institute and an investigator in the study. “The PAREPET
study conducted at the University of Buffalo has previously
indicated that PET C11 HED imaging may provide additional
information useful for the risk stratification of patients
considered for ICD placement. Our initial findings suggesting the
comparability of LMI 1195 and C11 HED are important. A new, widely
available non-invasive tool that could lead to a more precise
selection of patients prior to ICD implantation would be a very
welcome addition to the currently available, but limited
armamentarium.”
Nine participants were enrolled in the study. Participants (n=2
healthy controls; n=6 ischemic cardiomyopathy patients with left
ventricular (LV) ejection fraction (EF) =34±4; and n=1 non-ischemic
cardiomyopathy patient with EF=37%) underwent two separate PET
imaging visits within one week. On the first visit, participants
underwent N13 ammonia and dynamic HED PET imaging. On the second
visit, participants underwent dynamic LMI 1195 PET imaging. The
order of testing was randomized. HED and LMI 1195 retention index
(RI) was quantified to assess presynaptic sympathetic nerve
function. LV, lung, liver and blood standardized uptake values were
also determined at different time intervals.
The findings suggest that LMI 1195 yields a comparable estimate
of cardiac sympathetic innervation as C11 HED. LMI 1195 retention
index (r=0.89, p<0.0001) and defect score (r-0.99, p<0.0001)
correlated highly with HED. LV-to-lung ratios were comparable
between the two tracers. In addition, LMI 1195 seems to offer more
favorable kinetics for early cardiac imaging than HED. A
significant difference in blood clearance was observed between the
two tracers resulting in a LV-to-blood ratio of LMI-1195 higher
than HED within the first five minutes following administration
(p<0.05).
“We believe LMI 1195 may represent a first-in-class agent and
useful diagnostic tool for a significant population of patients at
risk for sudden cardiac death,” said Cesare Orlandi, M.D., Chief
Medical Officer of Lantheus Medical Imaging. “Nuclear imaging
provides a unique tool to measure the molecular changes in the
heart, including cardiac function of the norepinephrine transporter
(NET), in a non-invasive and repeatable manner. Lantheus developed
LMI 1195 to target the NET and we are encouraged by these initial
results that have been obtained in a variety of clinical
conditions. Data from this and other collaborations with academic
centers in Canada and Europe have allowed us to progress the LMI
1195 program to this stage and have provided the basis for the
initiation of a Phase 3 trial in ischemic cardiomyopathy patients
scheduled to receive an ICD. We look forward to initiating this
pivotal study later in the year.”
About LMI 1195LMI 1195, developed by Lantheus, is an
internally discovered small molecule that may be a first-in-class
fluorine-18-based PET radiopharmaceutical imaging agent designed to
assess cardiac sympathetic nerve function. LMI 1195 has the
potential to become a useful tool in the diagnostic assessment of
ischemic heart failure patients who may be at risk of sudden
cardiac death.
Heart failure is associated with changes in the cardiac
sympathetic nerve function. These changes appear early in the
development of heart failure. The cardiac neuronal norepinephrine
transporter (NET) has been shown to be a useful target for the
non-invasive monitoring of the cardiac sympathetic status and the
assessment of the likelihood of a heart failure patient to develop
fatal arrhythmias. Nuclear cardiac imaging provides a unique tool
to measure the molecular changes in the heart, including cardiac
function of NET, in a non-invasive and repeatable manner. Lantheus
developed LMI 1195 to target the NET and are encouraged by initial
results that have been obtained in a variety of conditions.
Phase 1 study findings showed that PET imaging with LMI 1195 has
favorable safety and dosimetry profiles in healthy volunteers. In
addition, LMI 1195 provided excellent quality whole-body images,
and the radiation dose to the subjects was found to be well within
acceptable limits. The data also showed that blood radioactivity
cleared quickly and lung activity was low throughout the study.
About Heart FailureHeart failure is a major public health
challenge because of high morbidity and mortality, frequent
hospitalizations, and its financial burden on the community. Heart
failure affects 6.5 million people in the U.S. today, and
approximately 2 million patients may be eligible for evaluation for
ICD implantation.1 The cost of heart failure continues to rise,
placing financial burden on the U.S. economy and healthcare system.
Overall heart failure costs were estimated to be approximately $31
billion in 2012.1 ICDs have been shown to effectively reduce
mortality rates.
About the University of Ottawa Heart InstituteThe
University of Ottawa Heart Institute is Canada's largest and
foremost heart health centre dedicated to understanding, treating
and preventing heart disease. UOHI delivers high-tech care with a
personal touch, shapes the way cardiovascular medicine is practiced
and revolutionizes cardiac treatment and understanding. It builds
knowledge through research and translates discoveries into advanced
care. UOHI serves the local, national and international community,
and is pioneering a new era in heart health.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging,
Inc.Lantheus Holdings, Inc. is the parent company of Lantheus
Medical Imaging, Inc. (“LMI”), a global leader in the development,
manufacture and commercialization of innovative diagnostic imaging
agents and products. LMI provides a broad portfolio of products,
including the echocardiography contrast agent DEFINITY® Vial for
(Perflutren Lipid Microsphere) Injectable Suspension; TechneLite®
(Technetium Tc99m Generator), a technetium-based generator that
provides the essential medical isotope used in nuclear medicine
procedures; and Xenon (Xenon Xe 133 Gas), an inhaled
radiopharmaceutical imaging agent used to evaluate pulmonary
function and for imaging the lungs. The Company is headquartered in
North Billerica, Massachusetts with offices in Puerto Rico and
Canada. For more information, visit www.lantheus.com.
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1 E.J. Benjamin, M.J Blaha, S.E. Chiuve et al. Heart Disease and
Stroke Statistics—2017 UpdateA Report From the American Heart
Association. Circulation. 2017;135:00–00. DOI:
10.1161/CIR.0000000000000485
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Lantheus Holdings, Inc.Meara Murphy, 978-671-8508Director,
Investor Relations & Corporate Communications
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