SOURCE: FluoroPharma Medical, Inc.

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November 03, 2014 08:54 ET

Journal of Nuclear Cardiology Publication States Preliminary Findings of Phase II Clinical Study Suggest FluoroPharma's CardioPET Has a Promising Role for the Identification of Functionally Significant Coronary Artery Disease

Case Study Presents Comparative Results Between CardioPET and SPECT; CardioPET Identified More Significant Cardiac Stenosis Than Did SPECT

MONTCLAIR, NJ--(Marketwired - November 03, 2014) - FluoroPharma Medical, Inc. (OTCQB: 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 announced an online publication in the Journal of Nuclear Cardiology on October 25, 2014 titled "A New F-18 Labeled PET Tracer For Fatty Acid Imaging."

The publication provides preliminary comparative results of an ongoing Phase II study of FluoroPharma's CardioPET (18-F FCPHA) fatty acid uptake indicator, which is designed to be used as a cardiac imaging agent and may prove to be an effective alternative to currently available diagnostic tests, including SPECT myocardial perfusion imaging.

The publication centered on "ischemic memory imaging"; whereby a change in the normal energy metabolism of the heart due to ischemia, may persist as long as 24-30 hours. Patients in various clinical settings, may be able to be diagnosed as having a significant ischemic event after the fact.

The author, Fabian Demeure, stated in the publication, "CardioPET images revealed alterations of fatty acid uptake in regions without abnormalities on Tc-99m-Sestamibi-SPECT. It better identified the extent of significant coronary stenosis than did Tc-99m-Sestamibi SPECT as demonstrated by coronary angiography."

This is the first data published from the study that directly compares CardioPET with the traditional standard of care, SPECT. 

Thijs Spoor, Chairman and CEO of FluoroPharma, commented, "The primary thesis behind our PET imaging products is that they can provide cardiologists with important new tools that will result in incremental diagnostic information for cardiac disease versus the current standard of care, SPECT imaging. We believe the results presented in this publication begin to prove out that important thesis."

Spoor continued, "We are encouraged with the data emerging from the CardioPET phase II trial. Previous presentations of this CardioPET study group have demonstrated a good safety profile, broad imaging window and the ability to obtain quantitative data. Comparative results with the standard of care and the angiographic gold standard will help us determine the advanced development plan for the compound." 

Fatty acid imaging represents an exciting potential option for evaluating the heart, and may be a factor in advancing the science. FluoroPharma believes that novel diagnostic imaging agents, like CardioPET, are urgently needed to provide healthcare professionals around the world with new products that expand and improve their diagnostic capabilities to diagnose disease more accurately at the earliest stages, leading to more effective treatment, better patient outcomes and cost saving for the healthcare system. 

The ongoing Phase II clinical trial is an open label study designed to assess the safety and diagnostic performance of CardioPET as compared to SPECT myocardial perfusion imaging agents and angiography, the current standards. This multicenter study is being conducted in Belgium. Data from this study has been presented at other major industry meetings in the US and Europe; including the Society of Nuclear Medicine and Molecular Imaging Mid-Winter and Annual Meetings, the 19th Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC) and at the Annual Congress of the European Association of Nuclear Medicine (EANM) in October 2014.

Editor's Notes:
Co-authors on the publication include Manuel D. Cerqueira, Michel Hesse, David Vancraeynest and Véronique Roelants.

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 is advancing two products in clinical trials for assessment of acute and chronic forms of coronary artery disease. These novel agents have been designed to rapidly target myocardial cells. Other active programs include the development of 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 and Mexico.

For more information on the company, please visit: www.fluoropharma.com

Forward-Looking Statements
Except for historical information contained herein, the statements in this release are forward-looking. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding FluoroPharma's research and development activities and anticipated operating results. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in FluoroPharma's filings with the United States Securities and Exchange Commission. FluoroPharma undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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