FluoroPharma Medical Announces Initial Data From Phase II Study for CardioPET(TM) (FCPHA)
FluoroPharma Medical, Inc. (OTCBB: FPMI), 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, today released images from the Phase II clinical trial for CardioPET™ (FCPHA) to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients.
CardioPET, one of FluoroPharma's first in class PET imaging products, is a perfusion and fatty acid uptake indicator, which is designed to be used as a cardiac imaging agent and may be a more specific alternative to currently available diagnostic tests. Management believes its pharmacokinetic characteristics could be especially valuable in patients who are unable to exercise.
The Phase II trial is an open label study designed to assess the safety and diagnostic performance of CardioPET as compared with myocardial perfusion imaging and angiography, the current gold standard. Trial sites are located in Belgium and results continue to be expected over the next six months.
According to Dr. Roland Hustinx, one of the investigators in the trial and head of nuclear medicine at the University Hospital in Liege, "The images obtained from CardioPET are high quality and agree with previous clinical findings."
Thijs Spoor, Chairman and CEO of FluoroPharma Medical, commented, "Today's announcement marks a significant milestone for FluoroPharma and CardioPET, one of the extraordinary products in our pipeline. It is clear that novel diagnostic imaging agents are urgently needed and we are focused on driving forward the development of our pipeline to provide healthcare professionals around the world with new products that expand and improve their diagnostic capabilities and contribute to earlier, more accurate diagnosis and treatment of disease -- even before symptoms appear. We are very excited about the images coming from the CardioPET trial. Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and accounts for a significant and increasing percentage of deaths," Mr. Spoor added.
About FluoroPharma Medical
FluoroPharma 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 positron emission tomography (PET) imaging agents and is advancing two products in clinical trials for assessment of acute and chronic forms of coronary disease. These first in class agents have been designed to rapidly target myocardial cells. Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, agents with the potential to image Alzheimer's disease and agents that could potentially be used for imaging specific cancers.
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, Finland, Portugal, Ireland and Mexico.
For more information on the Company, please visit: www.fluoropharma.com
CardioPET is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body. FFAs are the major source of energy for healthy myocardium, where they are transported into the mitochondria and are then metabolized via beta-oxidation. CardioPET has completed Phase I studies where it was well tolerated and did not induce any adverse events or clinically significant deviations in laboratory values. The total radiation exposure was minimal and well within safety limits.
About Coronary Artery Disease (CAD)
Coronary Artery Disease (CAD) is a leading cause of death and disability globally. The World Health Organization (WHO) estimated that more than 17 million people have died from heart attack, angina pectoris (chest pain) or both. It is also estimated that by 2030, this number will almost double.