FluoroPharma Announces CardioPET Phase II Results at the 21st American Society of Nuclear Cardiology (ASNC) Meeting
MONTCLAIR, NJ--(Marketwired - September 26, 2016) - FluoroPharma Medical Inc. (FPMI) announced today that data from its Phase II clinical trial for CardioPET were presented at the 21st Annual Meeting of the American Society of Nuclear Cardiology on September 24th, 2016 in Boca Raton, Florida.
The trial was conducted to determine the ability of cardiac PET imaging with 18-F FCPHA (CardioPET) to determine the presence and location of coronary artery disease (CAD) as compared with the current standard test for non-invasive diagnosis, SPECT imaging with Technetium-labeled compounds.
Dr. Gary Heller of Morristown (NJ) Medical Center presented the study results. Dr. Heller, an ASNC Past President, co-authored the study with the Principal Investigator Professor Olivier Gheysens, the Phase II clinical investigators in Belgium, and Dr. Manuel Cerqueira of the Cleveland Clinic.
Study subjects were enrolled based on abnormal findings for clinically indicated SPECT scans. They were then given a single dose of CardioPET with either a comparable exercise test (or pharmacologic stress), or at rest. Twenty-four subjects met the criteria for analysis. The SPECT and PET images were then compared to coronary angiography for assessment of diagnostic performance.
Dr. Heller stated, "We found that the image quality for CardioPET was significantly better than the comparative SPECT studies. Diagnostically, CardioPET correctly identified ischemia in both exercise and pharmacologic stress studies, and the overall diagnostic accuracy for CardioPET was confirmed to be comparable to that of SPECT."
Dr. Heller continued, "In this study, the unique fatty acid "signal" for CardioPET was shown to detect both ischemia and myocardial infarction. We were particularly intrigued with abnormal CardioPET images in subjects who were injected at rest, yet still had evidence of CAD on angiography. This indicates that it may be feasible to find CAD without an exercise test, and certainly should be studied further."
CardioPET is a modified fatty acid analog that mimics the heart's primary energy source, and enters the heart cells via normal physiologic processes. It has been modified to allow it to remain trapped in the myocardial cells after entry. Delivery of the radiopharmaceutical can be impaired by obstructive coronary disease, and damage to the myocardial cells themselves.
FluoroPharma President and CEO Thomas Tulip, PhD, commented, "We are pleased with the opportunity to present results at a focused Nuclear Cardiology meeting such as ASNC. We're delighted with the performance of CardioPET in this Phase II study and encouraged by this confirmation of the principal hypothesis, matching the vision of the inventor and the company."
Dr. Tulip added, "In addition to the comparative results, the intriguing finding that a CardioPET rest-only study may provide information currently available only with a much more resource intensive combination of rest and stress studies is extremely promising, and will be the subject of a study currently in design. With safety data from this trial scheduled to be presented at the upcoming EANM meeting, these presentations are important in supporting our strategic direction for the business."
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 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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