Lantheus Medical Imaging said that the U.S. Food and Drug Administration (FDA) has cleared a special protocol assessment (SPA) on the design and planned analysis of a phase III trial to assess myocardial perfusion with a new PET radiopharmaceutical.
Lantheus plans to initiate the first of two phase III trials in the second quarter of 2011. The trials will evaluate PET imaging with flurpiridaz F-18 in patients with suspected or known coronary artery disease. The two open-label trials are expected to enroll up to 1,350 patients with suspected or known coronary artery disease at approximately 100 clinical trial sites in Canada, Europe, South America, and the U.S.
The primary objective of the phase III program will be to assess the diagnostic efficacy of flurpiridaz F-18 PET myocardial perfusion imaging (MPI) versus SPECT MPI in detecting significant coronary artery disease.
An SPA is an agreement indicating that the proposed trial protocol, including clinical end points and statistical analyses, is acceptable to support regulatory approval of the treatment being evaluated.
Details from a phase II clinical trial will be presented at the ICNC10 - Nuclear Cardiology and Cardiac CT conference, being held in Amsterdam in May, the company said.
