Lantheus Holdings (LNTH) to Present New Data from First Phase 3 Study of Flurpiridaz F 18 for MPI Patients

September 22, 2016 4:22 PM EDT

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Lantheus Holdings, Inc. (NASDAQ: LNTH) today announced that new data from a sub-analysis of its first Phase 3 study of flurpiridaz F 18 for myocardial perfusion imaging (MPI) in patients undergoing exercise stress testing will be presented at the 21st Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC) in Boca Raton, Florida. The findings show the superiority of flurpiridaz F 18, an investigational positron emission tomography (PET) agent for MPI, compared to MPI with single photon emission computed tomography (SPECT) for the assessment of coronary artery disease (CAD) during exercise stress testing.

The oral presentation entitled, “Exercise Stress Testing with Flurpiridaz F 18 PET and Tc99m SPECT Myocardial Perfusion Imaging for the Assessment of CAD: A Subset Analysis of the Flurpiridaz F 18 301 Phase 3 Study,” will be presented by Rob Beanlands, M.D. of University of Ottawa Heart Institute on Saturday, September 24, 2016 at 10:45 a.m. ET in the Featured Oral Abstracts session of the meeting.

“Due to short half-life limitations of currently available tracers (13NH3 and 82Rb), PET myocardial perfusion imaging is commonly used in conjunction with pharmacologic stress testing,” said Dr. Beanlands, the lead author of the presentation. “The ability to perform PET imaging with exercise stress would allow us to gather important additional clinical information and also to use the same camera for both stress modalities. The results of this study provide evidence of the particular utility and future potential of flurpiridaz F 18 PET imaging for the diagnosis of coronary artery disease.”

Based on a blinded read of PET and SPECT data, flurpiridaz F 18 PET imaging demonstrated a statistically greater sensitivity (67.0%) versus SPECT (54.9%) (p<0.016) but lower specificity (73.8%) versus SPECT (85.4%) (non-significant for non-inferiority testing). Improved diagnostic performance of flurpiridaz F 18 PET imaging versus SPECT was also observed by ROC analysis (p<0.05). A significantly higher percentage of images were rated as either excellent or good quality with flurpiridaz F 18 PET imaging, compared to SPECT for rest images (p<0.001). No drug-related serious adverse events were observed.

The data are from a multicenter, international (United States, Canada, and Finland) Phase 3 study of flurpiridaz F 18 PET imaging. The study enrolled approximately 800 patients with known or suspected CAD who were scheduled for coronary angiography and conventional SPECT. Of these patients, 221 patients with known or suspected CAD underwent exercise stress flurpiridaz F 18 PET and SPECT imaging and coronary angiography.

"The Phase 3 data sub-analysis presented at ASNC demonstrates the ability to conduct flurpiridaz F 18 PET imaging for coronary artery disease detection in association with exercise stress testing,” said Cesare Orlandi, M.D., Chief Medical Officer of Lantheus Medical Imaging. “Flurpiridaz F 18 PET imaging also shows superiority over SPECT in this subpopulation not assessable with current standard PET imaging modalities. We believe improved diagnostic accuracy, coupled with reduced radiation exposure and potential for quantification of coronary flow reserve provide great promise for flurpiridaz F 18 to become the diagnostic imaging agent of choice for evaluating coronary artery disease.”

Lantheus is poised to commence the second of two Phase 3 trials for flurpiridaz F 18 PET imaging with a revised protocol in place under an FDA-approved Special Protocol Assessment and is in active negotiations with potential strategic partners to assist with the further development, manufacture and commercialization of this promising agent.

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