FluoroPharma and Philips Collaborate on Image Management for CardioPET Phase II Clinical Trial
Phase II Coronary Artery Disease Study Data Presented at EANM 2016
MONTCLAIR, NJ -- (Marketwired) -- 10/18/16 -- FluoroPharma Medical Inc. (OTCQB: FPMI) announced today 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, Advanced 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."
Royal Philips (NYSE: PHG)(AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips' health technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 69,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter
About FluoroPharma Medical
FluoroPharma (OTCQB: FPMI) is a biopharmaceutical company engaged in the discovery and development of proprietary PET imaging products to evaluate cardiac disease at the cellular and molecular levels. The Company has licensed technology from the Massachusetts General Hospital in Boston. The Company's goal is to enable personalized medicine through precision diagnostics that will help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment, management and better patient outcomes.
FluoroPharma's initial focus is the development of breakthrough PET imaging agents and the Company is advancing two products in clinical trials for assessment of acute and chronic forms of heart disease. These novel agents have been designed to rapidly target myocardial cells. In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia and Mexico. For more information on the Company, please visit: www.fluoropharma.com.
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Source: FluoroPharma Medical, Inc.