Lantheus Medical Imaging announced that it has reached agreement with the FDA regarding a special protocol assessment on the design and planned analysis of a phase III clinical trial for the assessment of myocardial perfusion using positron emission tomography imaging of flurpiridaz F-18 in patients with suspected or known coronary artery disease. The company plans to initiate the first of two planned phase III trials in the second quarter of 2011.
“The special protocol assessment agreement is a significant milestone in the development of flurpiridaz F-18 and provides us with a clearly defined path forward for the phase III programme,” said Don Kiepert, president and chief executive officer, Lantheus Medical Imaging. “We thank the FDA for their timely review and approval of this special protocol assessment and look forward to initiating the phase 3 programme 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.”
The phase III clinical development programme will include two open-label trials designed to assess myocardial perfusion using positron emission tomography imaging of flurpiridaz F-18 in approximately 1,350 patients with suspected or known coronary artery disease at approximately 100 clinical trial sites, including locations in the USA, 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 positron emission tomography myocardial perfusion imaging, compared with SPECT MPI in the detection of significant coronary artery disease.
Flurpiridaz F-18 has completed a phase II clinical trial, and analysis of the full data was presented at ICNC10 – Nuclear Cardiology and Cardiac CT Conference, Amsterdam, The Netherlands. Preliminary phase II data were presented at the Annual Meeting of the Society of Nuclear Medicine (SNM) in June 2010. These data showed that positron emission tomography 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 coronary artery disease. No serious adverse events attributable to flurpiridaz F-18 injection were reported in phase I or phase II clinical trials.
“The results of the phase II study with flurpiridaz F-18 are promising and we look forward to presenting the full data analysis later this year and initiating the phase III programme,” said Dana S Washburn, vice president, Clinical Development and Medical Affairs, Lantheus Medical Imaging. “Our phase III programme demonstrates our ongoing commitment to developing first-in-class imaging tools to advance patient care, and we remain dedicated to investigating the potential of positron emission tomography technology for evaluating cardiovascular disease.”
About FDA’s special protocol assessments
A special protocol assessment is an agreement between the sponsor and the FDA indicating that the sponsor`s proposed trial protocol, including clinical endpoints and statistical analyses, are acceptable to support regulatory approval of the treatment being evaluated. FDA approval for the product is dependent on efficacy results, adverse event profiles and an evaluation of the benefit/risk of a treatment as demonstrated in the clinical trials.
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), was designed to be a novel myocardial perfusion positron emission tomography imaging agent for the diagnosis of coronary artery disease. Positron emission tomography 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 coronary artery disease.