Lantheus Holdings has revealed the data from a sub-analysis of its first Phase III study of flurpiridaz F 18 for myocardial perfusion imaging (MPI).
Flurpiridaz F 18 is an investigational positron emission tomography (PET) MPI agent, which is currently in Phase III development.
Flurpiridaz F 18 injection is a fluorine 18-labeled agent, which binds to mitochondrial complex 1 (MC-1), and was designed to be a novel myocardial perfusion PET imaging agent that is expected to asssess patients with known or suspected CAD.
According to the firm, the data demonstrated the superiority of flurpiridaz F 18 over standard single photon emission computed tomography (SPECT) MPI for the assessment of coronary artery disease (CAD) in women.
The company has designed the first flurpiridaz F 18 Phase III study to evaluate the diagnostic efficacy of flurpiridaz F 18 with PET imaging against SPECT with Tc99m-labeled agents for CAD detection in the same patients.
In the trial, 235 women with suspected CAD underwent rest and stress PET and SPECT MPI and coronary angiography.
Lantheus Medical Imaging chief medical officer Dr Cesare Orlandi said: "We are very pleased with the additional Phase 3 data presented at the AHA meeting showing the advantages of flurpiridaz F 18 PET MPI for coronary artery disease detection in women.
"The study demonstrated a substantial gain in sensitivity without a loss of specificity over standard SPECT MPI."
Image: An example of a 59-year-old woman with angiographic stenoses >50% in the right and in the circumflex coronary arteries from Lantheus’ first Phase 3 study of flurpiridaz F 18. Photo: courtesy of Business Wire.