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Wednesday, June 09, 2010 10:13:14 AM
Perfusion Imaging Agent Protocol at SNM Annual Meeting
(Taken from my E*Trade news for POSC)
Flurpiridaz F 18 Data Determine Parameters for One-Day Rest-Stress Test to Detect
Coronary Artery Disease
NORTH BILLERICA, Mass., Jun 09, 2010 (BUSINESS WIRE) -- Lantheus Medical Imaging,
Inc., a worldwide leader in diagnostic medical imaging, today announced
preliminary Phase 2 data describing the methodology used to define an imaging
protocol for a one-day rest-stress myocardial perfusion imaging test using its
novel investigational PET imaging agent flurpiridaz F 18 injection (formerly
known as BMS747158). Flurpiridaz F 18 injection is in development for use with
Positron Emission Tomography (PET) for myocardial perfusion imaging (MPI) to
detect coronary artery disease. Data suggest that the uptake properties of
flurpiridaz F 18 injection make it possible to allow for a relatively low dosing
ratio and a delay of between 30 minutes and one hour between rest and stress
injections, depending on the mode of stress used.
Lantheus, together with its partner in this method development, Cardiovascular
Imaging Technologies of Kansas City, Mo., developed an innovative technique to
determine the dependence of the rest-to-stress dosing ratio in order to identify
the minimum delay between the two injections for a one-day rest-stress test. The
data were featured today in an oral presentation (# 798451) by Joel Lazewatsky,
Ph.D., Principal Research Scientist, Lantheus Medical Imaging, Inc., and in a
poster presentation (# 799099) on Tuesday, June 8 by James A. Case, Ph.D.,
Director of Physics at Cardiovascular Imaging Technologies, at the SNM 57th
Annual Meeting in Salt Lake City.
"Our team used data derived from a Phase 2 clinical study of flurpiridaz F18
injection PET MPI to define the optimal delay between rest and stress dosing as
part of an effort to determine the lowest total dose needed to obtain good
quality images," said Dr. Lazewatsky. "We are currently validating this model
with the second cohort of patients from the Phase 2 clinical study and we look
forward to the results."
To identify the appropriate amounts of rest and stress dosing for hypothetical
same-day rest and stress dosing, computer simulations of same-day rest and stress
images were developed using actual rest and stress image data obtained from 20
patients who were each imaged on a two-day basis. The actual rest and stress
images from the separate days together with the computer simulations of same-day
images were each reviewed in a blinded fashion by three experienced readers.
In evaluating the maximum residual contribution of the imaging agent initially
used in the rest study to the subsequent stress image which did not produce a
meaningful change in the reader's perception of the stress image, it was
determined for stress induced by adenosine (a pharmacological stress agent) that
a minimum dosing ratio of 2.0 (twice as much imaging agent used in stress as
compared to rest) was required with a 30 minute delay between injections. For
stress induced by exercise, a minimum dosing ration of 3.0 (three times as much
imaging agent used in stress as compared to rest) was needed with a one hour
delay between injections.
"Using this novel approach, we expect to validate a protocol that fits into
current clinical practice and that can be administered at the lowest possible
dose for patients undergoing a same-day rest-stress test with flurpiridaz F 18
injection," said Dana Washburn, M.D., Vice President, Clinical Development and
Medical Affairs, Lantheus Medical Imaging, Inc. "We developed this novel
methodology to define the rest and stress doses as well as the optimal delay
between the two doses without having to involve a large number of patients."
Drs. Lazewatsky and Case led the collaboration between Lantheus and
Cardiovascular Imaging Technologies to develop this unique approach to protocol
optimization. "This novel approach of modeling different dosages and time
intervals based on baseline image data not only enabled recognition of optimal
acquisition parameters for image quality and dosimetry, but dramatically
shortened development time that otherwise would have depended on trial and error
methodology," said Dr. Case.
About Flurpiridaz F 18 Injection
Flurpiridaz F 18 injection, a fluorine 18-labeled agent that binds to
mitochondrial complex 1 (MC-1), was designed to be a novel myocardial perfusion
PET imaging agent for the diagnosis of coronary artery disease (CAD). The agent
is currently in Phase 2 clinical development. CAD is the leading cause of death
in the United States for both men and women(1). Each year, more than half a
million Americans die from CAD(1).
In Phase 1 clinical studies, flurpiridaz F 18 injection was well-tolerated and
demonstrated radiation dosimetry that suggests that good quality images may be
obtained with patient radiation doses that are within accepted limits. The data
also showed high myocardial uptake at rest that significantly increased with
pharmacologically induced stress as well as a ratio of myocardial to background
uptake that was favorable and improved over time, suggesting encouraging
potential as a myocardial perfusion PET imaging agent for patients both at rest
and under stress.
About PET and MPI
Positron emission tomography, also called PET imaging or a PET scan, is a type of
nuclear medicine imaging procedure(2) 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 structure(3).
Myocardial perfusion imaging (MPI) is a non-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(4). MPI is used to identify
areas of reduced blood flow (perfusion) to the heart muscle(4). 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 disease(4). Although single-photon emission computer tomography
(SPECT) is most commonly used for MPI(5),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 stratification(6).
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for
more than 50 years, is dedicated to creating and providing pioneering medical
imaging solutions to improve the treatment of human disease. The company's proven
success in discovering, developing and marketing innovative medical imaging
agents provides a strong platform from which to bring forward breakthrough new
tools for the diagnosis and management of disease. Lantheus imaging products
include the echocardiography contrast agent DEFINITY(R) Vial for (Perflutren
Lipid Microsphere) Injectable Suspension, ABLAVAR(R) (gadofosveset trisodium), a
first-in-class magnetic resonance agent indicated for the evaluation of
aortoiliac occlusive disease in adults with known or suspected peripheral
vascular disease, TechneLite(R) (Technetium Tc99m Generator), Cardiolite(R) (Kit
for the Preparation of Technetium Tc99m Sestamibi for Injection), and Thallium
201 (Thallous Chloride Tl 201 Injection). Lantheus has more than 600 employees
worldwide with headquarters in North Billerica, Massachusetts, and offices in
Puerto Rico, Canada and Australia. For more information, visit
http://www.lantheus.com.
About Cardiovascular Imaging Technologies, LLC.
Cardiovascular Imaging Technologies, LLC. is based in Kansas City, Missouri.
CVIT's business interests include development of cardiac imaging software, core
imaging lab functions, new-agent consulting, technical support services, and
research support for Phases 1 through 4 investigations. Its core lab specializes
in modeling early Phase 1 and Phase 2 studies to help design more scientific and
accurate later stage clinical trials. The core lab also specializes in site
training and quality maintenance during later phase studies to insure data
consistency across a broad range of investigator instrumentation. It is a
recognized pioneer in the evolution of myocardial perfusion PET. Its processing,
quality control, and myocardial perfusion quantitation software is used by more
than 50% of PET centers that regularly perform myocardial perfusion imaging.
(1) National Institutes of Health, National Heart, Lung, and Blood Institute.
Coronary Artery Disease: Who Is At Risk.
http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhoIsAtRisk.html
(http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD%5fWhoIsAtRisk.html).
Accessed on June 4, 2010.
(2) Radiology Info. What is Positron Emission Tomography -- Computed Tomography
(PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed on
June 4, 2010.
(3) National Institutes of Health. NIH Clinical Center. Positron Emission
Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed on
June 4, 2010.
(4) Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion
Imaging. Version 3.0 June 2002. http://interactive.snm.org/docs/pg_ch02_0403.pdf
(http://interactive.snm.org/docs/pg%5fch02%5f0403.pdf).
(5) Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion.
Circ Cardiovasc Imaging. 2009; 2:412-424.
(6) 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.
SOURCE: Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc.
Priscilla Harlan, 978-671-8854
Cell: 781-799-7917
or
Pure Communications, Inc.
Michele Rozen, 617-730-8284
Cell: 617-953-2214
Copyright Business Wire 2010
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