Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design and planned analysis of a Phase 3 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). The Company plans to initiate the first of two planned Phase 3 trials in the second quarter of 2011.
"The SPA agreement is a significant milestone in the development of flurpiridaz F-18 and provides us with a clearly defined path forward for the Phase 3 program," said Don Kiepert, President and Chief Executive Officer of Lantheus Medical Imaging. "We thank the FDA for their timely review and approval of this SPA and look forward to initiating the Phase 3 program and building on the clinical trial results to date for this agent. We believe that flurpiridaz F-18 can improve the diagnosis and evaluation of coronary artery disease, ultimately reducing the need for additional medical tests and procedures."
Flurpiridaz F-18 has completed a Phase 2 clinical trial, and analysis of the full data set will be presented at ICNC10 - Nuclear Cardiology and Cardiac CT Conference scheduled for May 15-18, 2011 in Amsterdam, Netherlands. Preliminary Phase 2 data were presented at the Annual Meeting of the Society of Nuclear Medicine (SNM) in June 2010. These data showed that PET imaging with flurpiridaz F-18 provided better image quality than technetium-99m sestamibi single photon emission computed tomography (SPECT), the current standard for the non-invasive detection of CAD. No serious adverse events attributable to flurpiridaz F-18 injection were reported in Phase 1 or Phase 2 clinical trials. Numerous other abstracts based on single-center evaluation of flurpiridaz F-18 data were presented at various medical conferences in 2010.
"The results of the Phase 2 study with flurpiridaz F-18 are promising and we look forward to presenting the full data analysis later this year and initiating the Phase 3 program," said Dana S. Washburn, M.D., Vice President, Clinical Development and Medical Affairs at Lantheus Medical Imaging. "Our Phase 3 program demonstrates our ongoing commitment to developing first-in-class imaging tools to advance patient care, and we remain dedicated to investigating the potential of PET technology for evaluating cardiovascular disease."
The Phase 3 clinical development program will include two open-label trials designed to assess myocardial perfusion using PET imaging of flurpiridaz F-18 in approximately 1,350 patients with suspected or known CAD at approximately 100 clinical trial sites, including locations in the U.S., Canada, Europe and South America. The primary objective of the study will be to assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz F-18 injection PET myocardial perfusion imaging (MPI), compared with SPECT MPI in the detection of significant coronary artery disease.
Lantheus Medical Imaging, Inc.