FluoroPharma Inc., a company developing breakthrough molecular imaging agents for the Positron Emission Tomography (PET) market, announced positive Phase I results for BFPET, its novel Fluorine-18 labeled tracer for myocardial perfusion imaging.
BFPET is FluoroPharma’s second cardiovascular product to complete Phase I clinical development.BFPET is a PET imaging agent, designed to assess the blood flow in the heart (myocardial perfusion). Myocardial perfusion imaging 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, MD, PhD at the Massachusetts General Hospital, 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”, said Dr. Fischman, Professor of Radiology at Harvard Medical School. “Biodistribution results indicate fast blood clearance, rapid and stable myocardial uptake and high heart to background ratios.”
source: Fluoropharma
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