Positive Safety Results Reported for New Myocardial Perfusion Tracer for PET
July 24, 2008 - FluoroPharma said it achieved positive phase I test results for BFPET, a novel Fluorine-18 labeled tracer for PET myocardial perfusion imaging.
BFPET is designed to assess the blood flow in the heart (myocardial perfusion), which is a standard test to assess coronary artery disease (CAD), with more than 9 million Americans undergoing the test annually.
The phase I trial, led by principal investigator Alan J. Fischman, M.D., Ph.D. at the Massachusetts General Hospital, and a professor of radiology at Harvard Medical School, was designed to evaluate safety, distribution and dosimetry of BFPET in 12 healthy subjects following a single dose injection at rest.
“BFPET Phase I data demonstrates that the agent has a favorable dosimetry and pharmacokinetics profile and is well tolerated. All safety endpoints were achieved with no adverse events and no clinically significant changes noted in follow-up clinical and laboratory testing,” Dr. Fischman said. “Biodistribution results indicate fast blood clearance, rapid and stable myocardial uptake and high heart to background ratios.”
The company said the high quality cardiac images obtained in the study indicate that new cardiac PET imaging agents can expand the applications of PET beyond the use of FDG (2-Fluoro-2-deoxy-D-Glucose) in oncology and neurology.
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