Therapy Areas: Cardiovascular
GE Healthcare, Lantheus Start Phase 3 Clinical Trial of Investigational Agent for the Detection of Coronary Artery Disease
1 August 2018 - - US-based GE Healthcare and Lantheus Holdings, Inc. (NASDAQ: 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, the most common form of heart disease, the companies said.

CAD affects an estimated 15.5m 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 myocardial perfusion imaging in the detection of CAD.

In this prospective, open-label, study, patients with suspected CAD, for whom an intracoronary angiography 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.

In 2017, GE Healthcare and Lantheus Holdings, Inc, parent company of Lantheus Medical Imaging, 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.

GE Healthcare is the USD 19bn healthcare business of industrial company GE (NYSE: GE).

As a provider of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare enables precision health in diagnostics, therapeutics, and monitoring through intelligent devices, data analytics, applications, and services.

Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., a specialist in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. Lantheus provides a broad portfolio of products, which are primarily used for the diagnosis of cardiovascular diseases.
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