Lantheus Presents New Data on Novel Cardiac PET Imaging Agent LMI 1195 in Development for the Diagnostic Assessment of Ischemic Heart Failure Patients at Risk for Sudden Cardiac Death at ACC.18
Findings Show LMI 1195 Provides a Comparable Measure of Cardiac Sympathetic Nerve Function as PET imaging with C11 HED
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
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
About LMI 1195
LMI 1195, developed by
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
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 Failure
Heart 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
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Lantheus Holdings, Inc.
Meara Murphy, 978-671-8508
Director, Investor Relations & Corporate Communications