PET Myocardial Perfusion Imaging Agent Evaluated as Tool to Detect Coronary Artery Disease

(North Billerica, MA, USA), a worldwide developer of diagnostic imaging systems, reported that full results from the phase 2 clinical trial for the assessment of myocardial perfusion using PET imaging of flurpiridaz F18 in patients with suspected or known CAD were presented at the International Conference of Noninvasive Cardiovascular Imaging (ICNC10-Nuclear Cardiology and Cardiac CT) Conference, held May 15-18, 2011, in Amsterdam, The Netherlands. The full phase 2 data set was presented in a late-breaking presentation by Jamshid Maddahi, MD, FACC, professor of molecular and medical pharmacology (nuclear medicine) and medicine (cardiology) at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA; USA), and the lead investigator of the study.

"The preliminary phase 2 data of flurpiridaz F18 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 F18 has the potential to better evaluate patients with known or suspected coronary artery disease than SPECT [single photon emission computed tomography] imaging, and we look forward to initiating phase 3 clinical trials of this important new clinical tool in the second quarter of this year."

In March 2011, Lantheus received Special Protocol Assessment approval from the US Food and Drug Administration (FDA) for the phase 3 trial of flurpiridaz F18. The phase 3 open-label, multicenter trial will evaluate myocardial perfusion using PET imaging of flurpiridaz F18 in approximately 1,350 patients with suspected or known CAD. The chief objective of the study will be to assess the sensitivity and specificity of PET imaging with flurpiridaz F18 as compared to SPECT imaging.

Flurpiridaz F18 injection, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1), was designed to be an innovative myocardial perfusion PET imaging agent for the diagnosis of CAD, which is the most common form of heart disease, affecting approximately 16.8 million people in the United States.

Myocardial perfusion imaging (MPI) is a noninvasive 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 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. Although single-photon emission computer tomography (SPECT) is most typically used for MPI, 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.

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