August 3, 2012 — FluoroPharma Medical Inc., a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, announced that they have received high-quality images in an investigator-sponsored clinical trial in China where patients with coronary artery disease (CAD) were given BFPET, its imaging agent for measuring cardiovascular blood flow.
Patients are being imaged at the PLA 301 hospital in Beijing, where the images give a direct comparison between stress perfusion imaging using sestamibi and BFPET. According to Alan Fischman, former head of nuclear medicine at Massachusetts General Hospital and the principal investigator of the BFPET phase I trial: "Initial results are impressive. Image quality obtained using PET is superb. BFPET shows clear diagnostic qualities as well as increased resolution, inherent in PET. The initial images look spectacular, and we are confident that when all the patients are imaged, the data will further support clinical development of the agent."
Approximately 20 patients are expected to be imaged with this investigator-initiated study, concluding by the beginning of the fourth quarter of 2012.
"These images mark a milestone for BFPET and this exciting technology, bringing it a step closer to the world's medical community. We firmly believe, however, that the true beneficiaries of imaging agents like BFPET will be patients as it offers the potential for noninvasive diagnostic images with higher specificity. This will provide early and more accurate information to enable more effective patient management decisions," said Thijs Spoor, president and CEO of FluoroPharma. "Today's announcement supports our earlier findings and increases our confidence that the images we observed in phase I will be reproduced in phase II."
FluoroPharma's BFPET is a novel imaging agent for myocardial perfusion imaging (MPI) with the potential for measuring cardiovascular blood flow. BFPET, a fluorine-18 labeled tracer, has been designed to enter the myocardial cells in direct proportion to blood flow and cell membrane potential. These are two of the most important physiological indicators upon which adequate blood supply to the heart depends. BFPET has been designed to differentiate among those cells of the myocardium that may be ischemic, infarcted and those that are healthy.
Ischemic and infarcted cells should take up less BFPET than healthy myocardial cells. The signal emitted by BFPET should be inversely proportional to the extent of myocardial injury. Therefore FluoroPharma believes that ischemic heart tissue can be reliably detected by using BFPET.
Late last year, FluoroPharma announced that it had been granted patent rights in China for BFPET and another imaging agent, AZPET, which is still in early phases.
For more information: www.fluoropharma.com