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.”
“We are encouraged by the positive initial clinical safety results and look forward to validating BFPET’s performance in the next stage of development ” said Dr. David Elmaleh, FluoroPharma’s founder, Chief Scientific Advisor, and Associate Professor of Radiology at Harvard Medical School. “The high quality cardiac images obtained in this study indicate that new cardiac PET imaging agents can expand the applications of PET beyond the use of FDG (2-18Fluoro-2-deoxy-D-Glucose) in oncology and neurology. With two cardiac agents in clinical development and a third in our pipeline, FluoroPharma hopes to pave the way for cardiovascular PET.”
“We are delighted to have reached this important clinical milestone as it addresses the need for innovative agents that draw on the inherently superior resolution of PET imaging compared to SPECT.” said Dr. Kundakovic President of FluoroPharma. “There is tremendous opportunity for BFPET, as a PET alternative in the SPECT dominated myocardial perfusion imaging market. The use of BFPET in conjunction with PET technology holds the promise to better quality CAD diagnosis.”
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