GE Healthcare and Lantheus Holdings Inc., 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 (CAD), the most common form of heart disease.1 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 percent of all deaths among men and 20 percent of deaths among women each year. 3
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.”
In 2017, GE Healthcare and Lantheus Holdings Inc. announced the signing of a definitive license agreement for the continued Phase 3 development and worldwide commercialization of Flurpiridaz18F. Under this agreement, GE Healthcare will lead and fund the development of Flurpiridaz 18F, including the second Phase 3 clinical study. GE Healthcare will also have exclusive worldwide rights for the commercialization of Flurpiridaz18F. Lantheus will collaborate in both the development and commercialization process through a joint steering committee. Lantheus also maintains the option to co-promote the agent in the United States. VTN
READ MORE: https://clinicaltrials.gov/ct2/show/NCT03354273.
CITATIONS:
1 National Heart, Lung, and Blood Institute website. Coronary heart disease (also known as coronary artery disease).
http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhoIsAtRisk.html. Accessed July 25, 2018.
2 Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics–2016 update: a report from the American Heart Association. Circulation. 2016;133:e38-e360.
3 European Heart Network. European Cardiovascular Disease Statistics, 2017 edition. http://www.ehnheart.org/images/CVD-statistics-report-August-2017.pdf. Accessed July 25, 2018.
