NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced that full results from the Phase 2 clinical trial for the assessment of myocardial perfusion using Positron Emission Tomography (PET) imaging of flurpiridaz F 18 in patients with suspected or known coronary artery disease (CAD) will be presented at the ICNC10 - Nuclear Cardiology and Cardiac CT Conference, being held May 15-18 in Amsterdam. The full Phase 2 data set will be presented in a late-breaking presentation by Jamshid Maddahi, M.D., F.A.C.C., Professor of Molecular and Medical Pharmacology (Nuclear Medicine) and Medicine (Cardiology) at the David Geffen School of Medicine at UCLA, and the Lead Principal Investigator of the study.
“The preliminary Phase 2 data of flurpiridaz F 18 have been promising, and we are very excited to share the full data results with the scientific community at ICNC10,” said Don Kiepert, President and Chief Executive Officer of Lantheus Medical Imaging. “PET myocardial perfusion imaging with flurpiridaz F 18 has the potential to better evaluate patients with known or suspected coronary artery disease than SPECT imaging, and we look forward to initiating Phase 3 clinical trials of this important new clinical tool in the second quarter of this year.”
The presentation date and time is as follows:
|May 17, 2011; 8:42 a.m. (Central European Time)|
Phase 2 safety and clinical comparison of flurpiridaz F 18 injection PET and SPECT myocardial perfusion imaging for diagnosis of coronary artery disease
|Jamshid Maddahi, M.D., F.A.C.C., Professor of Molecular and Medical Pharmacology (Nuclear Medicine) and Medicine (Cardiology) at the David Geffen School of Medicine at UCLA|
Room 4 - Lecture Room
In March 2011, Lantheus received Special Protocol Assessment approval from the FDA for the Phase 3 trial of flurpiridaz F 18. The Phase 3 open-label, multicenter trial will assess myocardial perfusion using PET imaging of flurpiridaz F 18 in approximately 1,350 patients with suspected or known CAD. The primary objective of the study will be to evaluate the sensitivity and specificity of PET imaging with flurpiridaz F 18 as compared to SPECT imaging.
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 for the diagnosis of coronary artery disease (CAD). PET imaging with flurpiridaz F 18 has the potential to be a new clinical tool for the evaluation of myocardial perfusion that may better evaluate patients with known or suspected 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. 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. 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 single-photon emission computer tomography (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 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® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, ABLAVAR® (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® (Technetium Tc99m Generator), Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), and Thallium 201 (Thallous Chloride Tl 201 Injection). Lantheus has more than 650 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, including but not limited to, statements regarding the expected timing of the initiation of clinical trials, the expected number of patient enrollment and other factors 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 on May 11, 2011.
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 on May 11, 2011.
4 Radiology Info. What is Positron Emission Tomography – Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed on May 11, 2011.
5 National Institutes of Health. NIH Clinical Center. Positron Emission Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed on May 11, 2011.
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. Accessed on May 11, 2011.
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.
Lantheus Medical Imaging
Linda Lennox, 978-671-8854
Michele Rozen, 617-730-8284
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Cardiology Clinical Trials Hospitals Other Health