Lantheus Presents New Data on the Effectiveness of Novel PET Cardiac Imaging Agent Flurpiridaz F 18 in Women with Suspected Heart Disease at AHA Scientific Sessions 2015
Flurpiridaz F 18 Demonstrates Improved Coronary Artery Disease Detection and Reduced Radiation Exposure in Women over Standard SPECT MPI
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151108005040/en/
The moderated poster (#4424) titled, “Improved Assessment of CAD in
Women with Flurpiridaz F 18 PET Myocardial Perfusion Imaging: A Subset
Analysis of the Flurpiridaz F 18 301 Phase 3 Study,” will be presented
by
“While coronary heart disease is the leading cause of death in women, coronary artery disease remains under-diagnosed and under-treated in this population,” said Dr. Heller, the lead author of the sub-analysis. “The results of this study provide evidence of the usefulness and future potential of flurpiridaz F 18 PET imaging for the diagnosis of coronary artery disease in women.”
The data are from a multicenter, international (
In this flurpiridaz F 18 Phase 3 trial, 235 women with suspected CAD underwent rest and stress PET and SPECT MPI and coronary angiography. Flurpiridaz F 18 PET MPI was performed at rest and during pharmacologic or exercise stress testing. It is important to note that flurpiridaz F 18 can be used in conjunction with treadmill exercise, which is not generally feasible with currently used PET tracers for MPI. Results showed a statistically greater sensitivity for flurpiridaz F 18 (67.8%) versus SPECT (37.3%) (p<0.001). Similar specificity was shown for flurpiridaz F 18 (81.3%) versus SPECT (80.1%) (p=0.017 for non-inferiority testing). The diagnostic superiority of flurpiridaz F 18 versus SPECT was also demonstrated by ROC analysis (p<0.001).
Superior diagnostic accuracy was observed with flurpiridaz F 18 versus SPECT (77.9% vs. 69.4%, p=0.014). A significantly higher percentage of images were rated as either excellent or good quality with PET imaging, compared to SPECT imaging for stress images (p<0.001) and rest images (p<0.001). Diagnostic certainty of interpretation (the percentage of cases with definitely abnormal or definitely normal interpretation) was significantly higher for flurpiridaz F 18 PET compared to SPECT (89.8% vs. 74.5%, p<0.001). The agent was safe and well tolerated. Importantly, radiation exposure associated with flurpiridaz F 18 PET imaging was reduced to less than 50% of that associated with standard SPECT MPI.
“While one in every four female deaths is related to heart disease,
there remains an established need to provide clinicians with tools for
better and earlier detection to reduce the number of women who would
potentially go untreated,” said
"We are very pleased with the additional Phase 3 data presented at the
AHA meeting showing the advantages of flurpiridaz F 18 PET MPI for
coronary artery disease detection in women,” said
The Company is poised to move to completion its Phase 3 development
program for flurpiridaz F 18 with a revised protocol being initiated
under a Special Protocol Assessment agreed upon with the
About the Flurpiridaz F 18 First Phase 3 Study
The first flurpiridaz F 18 Phase 3 study was designed to assess the
diagnostic efficacy of flurpiridaz F 18 with positron emission
tomography (PET) imaging versus single photon emission computed
tomography (SPECT) with Tc99m-labeled agents for coronary artery disease
(CAD) detection in the same patients. Patients with known or suspected
CAD who were either scheduled for or had completed invasive coronary
angiography (without intervention) were included in the study. Each
patient was studied using both one-day rest/stress flurpiridaz F 18 PET
MPI and Tc99m-labeled SPECT MPI (one-day rest/stress or two-day
protocol). Images were interpreted by three expert readers blinded to
all clinical information. Quantitative coronary angiography (QCA) was
used as the truth standard, with patients considered CAD positive with a
stenosis ≥ 50% in at least one major vessel by QCA. Flurpiridaz F 18
substantially outperformed SPECT MPI, in sensitivity, one of the study’s
primary endpoints, but did not meet the study’s other primary endpoint,
non-inferiority for specificity, implying a substantial and unexpected
under-diagnosis of CAD with SPECT imaging in the trial. Unlike
flurpiridaz F 18, SPECT imaging results were skewed with low sensitivity
and high specificity when compared to the truth standard. In secondary
endpoints, flurpiridaz F 18 outperformed SPECT imaging in image quality
and diagnostic certainty with less than half of the radiation exposure
for patients. Subsequent to the initial read of the data, the Company
performed a re-read which confirmed the initial results as well as
showed improved performance of PET MPI as compared to SPECT imaging in
women and subjects with high body mass index. Based on the results of
the first Phase 3 study, the Company redesigned the protocol for its
second Phase 3 study, including different primary endpoints – namely,
the performance of flurpiridaz F 18 on its own merit versus coronary
angiography as the truth standard – and the Company has received a
Special Protocol Assessment from the
About Flurpiridaz F 18 Injection and Coronary Artery Disease
Flurpiridaz F 18 injection, a fluorine 18-labeled agent that binds to
mitochondrial complex 1 (MC-1)1, was designed to be a novel
myocardial perfusion positron emission tomography imaging agent that may
better evaluate patients with known or suspected coronary artery disease
(CAD), which is the most common form of heart disease2,
affecting an estimated 15.4 million Americans 20 years of age or older3.
CAD is the leading cause of death in
About PET and MPI
Positron emission tomography (PET), also called PET imaging or a PET scan, is a type of nuclear medicine imaging procedure6 that provides information about the function and metabolism of the body’s organs, unlike computed tomography (CT) or magnetic resonance imaging (MRI), which primarily show anatomy and structure7. Myocardial perfusion imaging (MPI) is a minimally invasive test that utilizes a small amount of radioactive material (radiopharmaceutical) injected into the body to depict the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow (perfusion) to the heart muscle. The test is typically conducted under both rest and stress conditions, after which physicians examine and compare the two scans and predict whether the patient has significant coronary artery disease8. Although single photon emission computed tomography (SPECT) is most commonly used for MPI9, PET imaging has gained considerable support and use in the field of cardiovascular imaging, as it offers many advantages to SPECT, including higher spatial and contrast resolution, which results in higher image quality and improved diagnostic accuracy, accurate attenuation correction and risk stratification10.
About
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are subject to risks and uncertainties that
may be described from time to time in our filings with the
# # #
1 Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J, Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP. Mechanism of uptake and retention of 18F BMS-747158-02 in cardiomyocytes: A novel PET myocardial imaging agent. Journal Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.
2
3 Heart Disease and Stroke Statistics. 2014 Update: A Report
From the
4
5
6 Radiology Info. What is Positron Emission Tomography –
Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET.
Accessed
7
8
9 Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.
10 Heller, G, Calnon, D and Dorbala, S. Recent Advances in Cardiac PET and PET/CT Myocardial Perfusion Imaging. J Nucl Cardiol 2009; 16:962-9.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151108005040/en/
Source:
Lantheus Holdings, Inc.
Investor Relations
John
Bakewell, 978-436-7073
or
Media Relations
Meara
Murphy, 978-671-8508