SOURCE: FluoroPharma Medical, Inc.

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October 20, 2014 08:30 ET

FluoroPharma Announces That Data From Its Phase II Clinical Trial of 18-F FCPHA (CardioPET) Was Presented at the Annual Congress of the European Association of Nuclear Medicine (EANM), October 19, 2014, in Gothenburg, Sweden

Investigator Phase II Data Presented for the First Time in Europe

MONTCLAIR, NJ--(Marketwired - October 20, 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 that new Phase II data related to CardioPET (18-F FCPHA) for the assessment of myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients was presented by Dr. Fabian Demeure, an author of the abstract, at the session: Cardiovascular System: Cardiac PET Imaging on October 19th at the Annual Congress of the European Association of Nuclear Medicine (EANM), October 18 - 22, 2014, in Gothenburg, Sweden.

Dr. Fabian Demeure, a Cardiologist at Cliniques Universitaires Saint Luc, Bruxelles, presented data from the abstract entitled, FCPHA (CardioPET), a novel F-18 fatty acid analog for myocardial PET imaging: Preliminary results of safety, image quality and optimal timing from a phase II trial.

Dr. Demeure concluded that the compound was "safe and well tolerated in this cohort, and that the combination of early and rapid blood clearance with limited liver interference makes this a promising tracer for fatty acid imaging with PET. We have been pleased with the consistency of the tracer across subsequent observations," he added.

CardioPET, one of FluoroPharma's PET imaging products, is a 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.

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; including the Society of Nuclear Medicine and Molecular Imaging Mid-Winter and Annual Meetings, and at the 19th Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC) held last month.

Thijs Spoor, Chairman and CEO of FluoroPharma, commented, "This marks the first time that CardioPET data was presented in Europe and we are pleased that it was at the Annual Congress of the European Association of Nuclear Medicine. We are also delighted that CardioPET was considered a highlight of the meeting. CardioPET is progressing well through Phase II and data obtained at various intervals strengthens our confidence, as we look forward to the completion of this study and in planning for the next phase of clinical trials. Fatty acid imaging represents an exciting potential option for evaluating the heart, and may be a factor in advancing the science. I believe the CardioPET data presented throughout this year at major medical meetings confirms the emergence of PET as an important force in cardiac molecular imaging. We believe 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." 

Editor's Notes

Co-authors on this presentation include Manuel Cerqueira, Cleveland Clinic, USA; Olivier Gheysens and Andre Postnov, KU Leuven, Belgium; Roland Hustinx and Claire Bernard, Universite de Liege, Belgium; Michel Hesse, David Vancraeynest and Veronique Roelants, Universite Catholique de Louvain, Brussels, Belgium.

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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