BioCentury
ARTICLE | Clinical News

Lantheus reports Phase III data for imaging agent

October 30, 2013 12:53 AM UTC

Lantheus Medical Imaging Inc. (North Billerica, Mass.) reported data on Tuesday from a Phase III trial evaluating PET myocardial perfusion imaging (MPI) with the company's flurpiridaz F 18 injection to diagnose coronary artery disease (CAD) in 740 patients with suspected or known CAD. Flurpiridaz F 18 met the co-primary endpoint of superior sensitivity to single photon emission computed tomography (SPECT) MPI, but missed the co-primary endpoint of non-inferior specificity to SPECT MPI. Lantheus said the SPECT results showed "surprisingly low sensitivity and elevated specificity" that are "inconsistent with prior studies," including a Phase II trial with flurpiridaz F 18, and "may have confounded the outcome of the trial." ...