FluoroPharma Medical (FPMI) announced that it has been collaborating with Philips for data management in conjunction with its Phase II clinical trials for its lead agent CardioPET (18-F FCPHA).
Safety and image data from the CardioPET study was presented at the European Association of Nuclear Medicine Annual Congress in Barcelona, Spain, on October 16th.
CardioPET is a modified fatty acid that enters the heart in the same way as naturally occurring free-fatty acids, the heart's primary energy source. Understanding fatty acid metabolism in the context of known or suspected coronary artery disease may provide physicians with a new tool in understanding the evolution of cardiovascular disease.
The Phase II study, conducted in Belgium, was designed to test the ability of CardioPET to identify coronary artery disease in patients with positive clinically indicated SPECT scans. According to the investigators, the study was completed with no deaths or serious adverse events reported. Images demonstrate evidence of coronary artery disease in subjects with confirmation by SPECT and invasive angiography.
The CardioPET image data was put through a rigorous quality assurance process. For this, FluoroPharma collaborated with Philips and its Advanced Molecular Imaging technology to ensure that uniform standards were carefully applied to data from their advanced imaging systems across clinical sites.
"We look forward to working closely with Philips to optimize our image quality and potentially design new approaches tailored to the specific features of CardioPET," FluoroPharma President and CEO Thomas Tulip, Ph.D. commented.
"With new CardioPET data being presented at the recent ASNC meeting, as well as EANM, we believe this kind of alliance will strengthen the opportunity for cardiac PET imaging by bringing equipment/software and drug development worlds closer together for more effective trial execution and eventual commercial success."
Piotr Maniawski, Director of Clinical Science, Advnaced Molecular Imaging at Philips commented: "It is critical to ensure that the optimal image processing methodology is applied during the evaluation of performance of new radiotracers.
“We are honored that FluoroPharma engaged Philips very early in the process of data collection and evaluation, providing the unique opportunity to be a part of an effort aimed at improving molecular imaging in cardiology."