Lantheus Medical Imaging announces preliminary data on flurpiridaz F 18 PET MPI agent

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced preliminary data on flurpiridaz F 18 (formerly known as BMS747158), its novel compound in development as a Positron Emission Tomography (PET) myocardial perfusion imaging (MPI) agent. The study of nine patients compared rest-stress flurpiridaz F 18 PET MPI, with rest-stress technetium-99m (Tc-99m) labeled single photon emission computed tomography (SPECT) for the detection and evaluation of coronary artery disease (CAD). Preliminary results from the single-center study suggest that compared to SPECT MPI, flurpiridaz F 18 PET MPI has a higher diagnostic specificity for detecting right coronary artery disease and a higher accuracy for evaluating the extent of stress-induced myocardial perfusion abnormalities with coronary angiography as the gold standard. The data were featured today in an oral presentation (# 0917-03) by Jamshid Maddahi, M.D. F.A.C.C., Professor of Molecular and Medical Pharmacology (Nuclear Medicine) and Medicine (Cardiology) at the David Geffen School of Medicine at UCLA, and the Lead Principal Investigator of the study, at the American College of Cardiology 59^th Annual Scientific Session in Atlanta.

“Lantheus is fully committed to the ongoing evaluation of flurpiridaz F 18 PET imaging to further understand the diagnostic impact it may have in detecting coronary artery disease, the nation’s leading cause of death”

“These initial results, in a very small patient population, are encouraging, as they already show significant improvements in diagnostic accuracy using PET imaging with flurpiridaz F 18 as compared to SPECT imaging with Tc-99m for the detection and evaluation of coronary artery disease,” said Dr. Maddahi. “A product that could demonstrate increased diagnostic specificity would provide physicians with a useful tool to reduce the number of false positive results often associated with SPECT imaging, and, therefore reduce the number of unnecessary cardiac catheterizations.”

Nine patients from a single study center underwent same day rest-stress Tc-99m labeled SPECT MPI and separate day rest-stress flurpiridaz F 18 PET MPI and coronary angiography. For each patient, 17 myocardial segments were visually scored for each rest and stress image by independent observers who were blinded to the other results. Summed stress scores, summed rest scores and summed difference scores were determined for each patient from the segmental scores. The percentage of narrowing in each coronary artery was evaluated blindly, and greater than 70 percent luminal diameter narrowing was considered significant.

Findings showed that the overall accuracy for correct identification of diseased coronary arteries was 93 percent (25/27) for PET and 78 percent (21/27) for SPECT. Six patients were found to have CAD with both SPECT and PET, and for the three patients without CAD, all three were found to be normal through PET imaging and two were found to be normal through SPECT. Of the nine diseased coronary arteries, PET detected all and SPECT detected eight. Of the 18 normal coronary arteries, PET imaging identified 16 of the 18 arteries while SPECT found 13 of the 18. Specificity for the right coronary artery was significantly higher through PET imaging compared to SPECT (p<0.05): 100 percent compared to 43 percent.

“These preliminary data for flurpiridaz F 18 PET MPI indicate that more accurate diagnosis of the large segment of coronary artery disease may be possible than with currently available MPI procedures,” said Alex Ehlgen MD, Associate Medical Director, Clinical R&D, Lantheus Medical Imaging, Inc. “PET perfusion imaging continues to be examined as an important advance in myocardial perfusion imaging, and we look forward to Phase 2 study results for this novel agent.”

“Lantheus is fully committed to the ongoing evaluation of flurpiridaz F 18 PET imaging to further understand the diagnostic impact it may have in detecting coronary artery disease, the nation’s leading cause of death,” added Don Kiepert, President and Chief Executive Officer, Lantheus Medical Imaging, Inc. “A new, improved perfusion tracer for use with PET imaging could lead to improved detection and characterization of coronary artery disease, resulting in better patient outcomes.”