FluoroPharma, Inc., a company developing breakthrough cardiovascular molecular imaging agents for the Positron Emission Tomography (PET) market, announced commencement of Phase I clinical trials for BFPET, following institutional review board (IRB) approval of the proposed studies. The Phase I trial is a single center, open label study, designed to evaluate safety, distribution and dosimetry of BFPET as a PET tracer for myocardial perfusion imaging in healthy subjects. The study will be led by Dr. Alan Fischman, Professor of Radiology at Harvard Medical School and former Director of the Nuclear Medicine Division at Massachusetts General Hospital. BFPET is FluoroPharma’s second cardiovascular PET agent to enter clinical trials.
BFPET is a PET blood flow imaging agent, for use in classic “rest-stress” cardiac testing. More than 9 million Americans each year undergo myocardial perfusion imaging, the standard test to assess coronary artery disease (CAD). BFPET, as a PET imaging tracer, may have a significant advantage due to its potential to improve the sensitivity and specificity of CAD diagnosis and to provide information on myocardial mitochondrial damage. “This agent, if successful, should improve CAD diagnosis and follow–up of therapy and intervention, and broaden the utility of PET as an imaging modality”, said Dr. 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.”
“We are delighted to have our second product enter clinical trials”, said Dr. Ljiljana Kundakovic, FluoroPharma’s President. “BFPET’s progress follows on the tail of CardioPET, an agent for the detection of metabolic integrity of the heart, which recently completed a Phase I safety evaluation in normal healthy volunteers and cardiac patients. FluoroPharma has the potential to significantly impact diagnosis of cardiovascular disease with multiple PET imaging agents targeting a wide range of indications.”
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