First phase of Flurpiridaz F 18 clinical trial meets criteria


May 7, 2013 – Lantheus Medical Imaging, Inc., a developer of diagnostic imaging agents, announced an interim analysis of the first of two Phase 3 studies of its flurpiridaz F 18 clinical program has met the criteria for completion.  

To date, approximately 900 subjects have been imaged with flurpiridaz F 18. The Phase 2 clinical study for flurpiridaz F 18 established optimal rest and stress protocols and indicated that the agent has a superior profile over single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

The Phase 3 clinical development program includes two trials in approximately 1,400 patients at clinical trial sites in North America and Europe. Both Phase 3 clinical studies have received a Special Protocol Assessment from the U.S. Food and Drug Administration. The primary objective of the Phase 3 clinical program is to assess myocardial perfusion using positron emission tomography (PET) imaging with flurpiridaz F 18 in patients with known or suspected coronary artery disease (CAD). The first of the two Phase 3 studies has passed the interim analysis assessment milestone and should be completed later in the year.

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First phase of Flurpiridaz F 18 clinical trial meets criteria.  Appl Radiol. 

May 07, 2013

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