Summary: Lantheus Medical Imaging, Inc. 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.
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)
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.
For more information: www. www.clinicaltrials.gov, www.lantheus.com, and www.appliedradiology.com