Molecular imaging radiotracer developer FluoroPharma reported positive Phase I results for BFPET, a fluorine-18 labeled tracer for PET-based myocardial perfusion imaging.
The firm noted that BFPET is FluoroPharma’s second cardiovascular product to complete Phase I clinical development. The Phase I trial, led by principal investigator Alan J. Fischman, MD, PhD, at Massachusetts General Hospital in Boston, 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 Fischman. “Biodistribution results indicate fast blood clearance, rapid and stable myocardial uptake, and high heart-to-background ratios.”
FlouroPharma said it believes that there is tremendous opportunity for BFPET as a PET alternative in the SPECT dominated myocardial perfusion imaging market.