GE Healthcare And Lantheus Announce Start Of Phase 3 Trial Of Flurpiridaz

(RTTNews) - GE Healthcare and Lantheus Holdings Inc. (LNTH), parent company of Lantheus Medical Imaging, Inc., have started a second Phase 3 clinical trial of Flurpiridaz 18F (called the AURORA study), an investigational agent being evaluated for the detection of coronary artery disease or CAD, the most common form of heart disease.

CAD affects an estimated 15.5 million Americans 20 years of age or older and is the leading cause of death in the United States1 and in Europe, where CAD is responsible for 19% of all deaths among men and 20% of deaths among women each year.

The AURORA study is an international, multicenter study to evaluate diagnostic efficacy of Flurpiridaz 18F Injection positron-emission tomography (PET) myocardial perfusion imaging or MPI in the detection of CAD. In this prospective, open-label, study, patients with suspected CAD, for whom an intracoronary angiography (ICA) has been indicated, will undergo a single-photon emission computed tomography (SPECT) MPI and Flurpiridaz 18F Injection PET MPI prior to the performance of coronary angiography.

The primary endpoint is the diagnostic efficacy of Flurpiridaz 18F Injection PET MPI for the detection of significant CAD. The first patient was enrolled in the study in June 2018. A total of 650 patients will be enrolled, with the last patient follow-up projected to occur in August 2020.