FluoroPharma, a cardiovascular molecular imaging agent developer for the PET market, has commencement of Phase I clinical trials for BFPET, to evaluate safety, distribution and dosimetry of BFPET as a PET tracer for myocardial perfusion imaging in healthy subjects, following institutional review board approval of the proposed studies.
The Phase I trial, a single-center, open-label study, will be led by Alan Fischman, MD, professor of radiology at Harvard Medical School and former director of the nuclear medicine division at Massachusetts General Hospital in Boston.
BFPET, a PET blood flow imaging agent, for use in classic "rest-stress" cardiac testing, is FluoroPharma's second cardiovascular PET agent to enter clinical trials, the company said.
As a PET imaging tracer, BFPET may have a significant advantage due to its potential to improve the sensitivity and specificity of coronary artery disease diagnosis and to provide information on myocardial mitochondrial damage, according to David Elmaleh, FluoroPharma's chairman and scientific founder. "BFPET has performed well in animals with a target-to-blood ratio of 70:1, and we look forward to evaluating the agent in human studies,” he said.