N. BILLERICA, MA--(Marketwired - September 18, 2014) - Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents, today announced that data demonstrating significant reductions in radiation exposure and improved image quality with flurpiridaz F 18 myocardial perfusion imaging (MPI) as compared with single photon emission computed tomography (SPECT) will be presented in a poster presentation at the American Society of Nuclear Cardiology (ASNC) 19th Annual Scientific Session, being held September 18-21, 2014 in Boston. The data were collected in the first of the Company's Phase 3 clinical trials. Flurpiridaz F 18 is an investigational positron emission tomography (PET) MPI agent currently in Phase 3 development.
The poster presentation (abstract #443), "Radiation Dose to Patients in a Phase 3 Trial of Flurpiridaz F 18, a New Radiopharmaceutical for PET Myocardial Perfusion Imaging," will be presented by Jamshid Maddahi, M.D., Professor of Medicine (Cardiology) and Molecular & Medical Pharmacology (Nuclear Medicine) David Geffen School of Medicine at UCLA, in the Expo Hall at the Seaport World Trade Center on Saturday, September 20 from 3:00 p.m. to 4:00 p.m. E.T.
"We are pleased to present this additional data on our cardiovascular PET imaging candidate flurpiridaz F 18 at ASNC," 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 further important information regarding the benefit-risk assessment of the agent in myocardial perfusion imaging. We believe this agent could significantly reduce patient radiation exposure and at the same time provide better, more useful images for clinicians. Lantheus is committed to advancing its 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."
"Analysis of the first Phase 3 clinical study has demonstrated a statistically and clinically significant reduction in radiation exposure achieved with flurpiridaz F 18 as compared with standard SPECT imaging," said Jamshid Maddahi, MD, the Principal Investigator of the study. "This was in the presence of significant improvements in image quality and diagnostic certainty. These results provide additional evidence for flurpiridaz F 18 as a potentially important new advancement in nuclear cardiology."
As the Company completes planning for the conduct of the second Phase 3 trial for flurpiridaz F 18, it remains in active discussions with prospective strategic partners for the completion of development and, if approved, 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[2], affecting an estimated 15.4 million Americans 20 years of age or older[3]. CAD is the leading cause of death in the United States for both men and women[2]. Each year more than 400,000 Americans die from CAD[2]. The flurpiridaz F 18 Phase 2 study results were published in the Journal of the American College of Cardiology (JACC) on January 29, 2013[4].
About PET and MPI
Positron emission tomography, also called PET imaging or a PET scan, is a type of nuclear medicine imaging procedure[5] 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[6]. 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 disease[7]. Although SPECT is most commonly used for MPI[8], 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[9].
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc. is a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents. The Company provides a broad portfolio of products, which are primarily used for the diagnosis of cardiovascular diseases. Lantheus' key products include 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.
Lantheus has more than 500 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] 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 September 2014.
[3] Heart Disease and Stroke Statistics. 2014 Update: A Report From the American Heart Association. Circulation. 2014;129:e28-e292.
[4] Berman, D.S., Maddahi,J., et al. Phase II Safety and Clinical Comparison with Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease: Flurpiridaz F 18 Positron Emission Tomography. J AM Coll Cardiol. 2013 Jan; 61(4):469-77.
[5] Radiology Info. What is Positron Emission Tomography - Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed September 2014.
[6] National Institutes of Health. NIH Clinical Center. Positron Emission Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed September 2014.
[7] Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion Imaging. Version 3.0 June 2002. http://interactive.snm.org/docs/pg_ch02_0403.pdf.
[8] Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.
[9] 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.
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