GE Healthcare and Lantheus Holdings, parent company of Lantheus Medical Imaging, 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 (CAD), the most common form of heart disease.
CAD affects an estimated 15.5 million Americans 20 years of age or older2 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 (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 (sensitivity and specificity) 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.
Kevin O’Neill, General Manager of Core Imaging for GE Healthcare, said, “We are thrilled to see this critical stage of the study move forward. We are committed to the development of a potential new diagnostic option for clinicians and their CAD patients in the future.”
Mary Anne Heino, President and CEO of Lantheus, commented, “The second Phase 3 study of Flurpiridaz 18F represents a significant milestone in the development of this promising investigational agent. Importantly, it illustrates our strong collaboration with GE Healthcare, and we look forward to the continued progress of the clinical program.”
Source: Company Press Release