Lantheus Medical Imaging to Present Data on Novel PET Cardiac Imaging Agent Flurpiridaz F 18 at ICNC 11th Annual Meeting
N. BILLERICA, Mass. (April 29, 2013) – Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced that data assessing the value of flurpiridaz F 18 myocardial standardized uptake value (SUV) analysis in the clinical assessment of intermediate to severe coronary stenosis will be presented in an oral presentation at the International Conference on Nuclear Cardiology and Cardiac CT (ICNC) 11th Annual Meeting, being held May 5-8, 2013 in Berlin. The data were collected from six of the Company’s Phase 2 clinical trial sites. Flurpiridaz F 18 is an investigational Positron Emission Tomography (PET) myocardial perfusion imaging (MPI) agent currently in a Phase 3 clinical trial.
The oral presentation (abstract #162), “Value of Flurpiridaz F 18 Myocardial SUV Analysis in Clinical Assessment of Intermediate to Severe Coronary Stenosis,” will be presented by Joel Lazewatsky, Ph.D., Director, Clinical Imaging for Lantheus Medical Imaging, in Room A05 on May 7, 2013 at 9:06 AM CEST.
"We are pleased to present this additional data on our cardiovascular PET imaging candidate flurpiridaz F 18 at the ICNC,” said Cesare Orlandi, M.D., Chief Medical Officer of Lantheus Medical Imaging. “This data builds upon the previous flurpiridaz F 18 Phase 2 findings and provides new information regarding the potential clinical utility of the agent in coronary stenosis. Lantheus is committed to advancing our pipeline of next generation diagnostic medical imaging products, and we see great promise in flurpiridaz F 18 as a novel PET imaging tool for the diagnosis and evaluation of coronary artery disease.”
Data from a Phase 2 clinical trial with flurpiridaz F 18 were first presented at the ICNC 10th Annual Meeting in 2011. The Phase 2 data demonstrated that PET MPI with flurpiridaz F 18 provided superior image quality, diagnostic certainty and diagnostic performance for detecting coronary artery disease (CAD) compared to single photon emission computed tomography (SPECT) MPI, the current standard for the non-invasive detection of CAD. The data also demonstrated a positive safety profile for PET imaging with flurpiridaz F 18.
As the Company completes its first of two Phase 3 trials for flurpiridaz F 18, it is in active discussions with prospective strategic partners for the second Phase 3 study and commercialization of this promising agent.
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 PET imaging agent that may better evaluate patients with known or suspected coronary artery disease (CAD). CAD is the most common form of heart disease, affecting approximately 16.8 million people in the United States2. CAD is the leading cause of death in the United States for both men and women3. Each year more than half a million Americans die from CAD3.
About PET and MPI
Positron Emission Tomography, also called PET imaging or a PET scan, is a type of nuclear medicine imaging procedure4 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 structure5. 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. 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 disease6. Although SPECT is most commonly used for MPI7, 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 stratification8.
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, is dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The Company’s proven success in the field of diagnostic imaging 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® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, TechneLite® (Technetium Tc 99m Generator), Cardiolite® (Kit for the Preparation of Technetium Tc 99m Sestamibi for Injection), and Thallium 201 (Thallous Chloride Tl 201 Injection). Lantheus has approximately 550 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.
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 Securities and Exchange Commission. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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 Cleveland Clinic. Coronary Artery Disease – Risk Factors. http://my.clevelandclinic.org/heart/prevention/riskfactors.aspx. Accessed April 2013.
3 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. Accessed April 2013.
4 Radiology Info. What is Positron Emission Tomography – Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed April 2013.
5 National Institutes of Health. NIH Clinical Center. Positron Emission Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed April 2013.
6 Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion Imaging. Version 3.0 June 2002. http://interactive.snm.org/docs/pg_ch02_0403.pdf.
7 Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.
8 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.