FluoroPharma Medical Inc. (OTCBB:FPMI), a Boston diagnostic imaging product developer, said it is starting a Phase 2 trial of its positron emission tomography (PET) technology for coronary artery disease, and has hired Swiss contract research organization SGS Life Science Services to run the study.
FluoroPharma’s President and CEO Thijs Spoor said the trial is a significant milestone for the company. “Symptomatic coronary artery disease affects millions of patients worldwide and accounts for a significant and increasing percentage of all deaths. It is clear that novel diagnostic imaging agents are urgently required, and we are focused on driving forward the development of our pipeline to meet these needs,” he said in a statement.
The study will be an open label trial designed to assess the safety and diagnostic performance of FluoroPharma’s CardioPET imaging product compared to stress echocardiography, myocardial perfusion imaging, and angiography. Two trial sites are planned in Belgium and results are expected in the second half of 2012.
CardioPET is a perfusion and fatty acid uptake indicator that can be used as a cardiac imaging agent as an accurate alternative to standard treadmill stress-testing. This could be valuable in patients who are unable to exercise, the company said.
David Elmaleh, FluoroPharma’s chief scientific officer, said CardioPET could have a significant impact on the evaluation of coronary artery disease patients across the spectrum of disease severity. Because the technology can detect perfusion and fatty acid uptake insufficiency in the myocardium, it could potentially be an accurate alternative to stress-testing in patients with the disease, he said.
CardioPET is a modified fatty acid that closely resembles naturally-occurring free fatty acids in the human body. Free fatty acids are the major source of energy for healthy myocardium, where they are transported into the mitochondria and are then metabolized. CardioPET was well tolerated in Phase I studies, the company said, and it did not induce any adverse events or clinically significant deviations in laboratory values. The total radiation exposure was minimal and within safety limits.