SOURCE: FluoroPharma Medical, Inc.

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September 22, 2014 11:25 ET

FluoroPharma Announces That Data From Its Phase II Clinical Trial of 18-F FCPHA (CardioPET) Was Presented at the 19th Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC), September 20th in Boston, MA

Encouraged by Phase II Progress for CardioPET, Company is Planning Next Stages of Development

MONTCLAIR, NJ--(Marketwired - September 22, 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 at the 19th Annual Scientific Session of ASNC, held this weekend, by the lead author of the abstract, Dr. Manuel Cerqueira. 

Dr. Cerqueira, Chairman of the Department of Nuclear Medicine at the Cleveland Clinic and a past president of ASNC, presented interim data summarized in the abstract Preliminary Evaluation of Safety, Image Quality and Timing of Acquisition for a Novel Free Fatty Acid PET imaging Agent, 18-F FCPHA (CardioPET).

According to Dr. Cerqueira, "The distribution of the tracer is an important factor for any new cardiac imaging agent, since adjacent structures can interfere with interpretation. We used a semi-quantitative method to evaluate distribution between the heart and other organs. In our analysis, studies performed at rest, with exercise or pharmacologic stress provided interpretable images from 5-60 minutes post-injection. Blood pool was absent in all patient images after 5 minutes. While liver activity is present, it did not interfere with the evaluation of the heart."

In responding to a question regarding a SPECT fatty acid tracer following the presentation, Dr. Cerqueira suggested that while there are no comparative data with these agents, PET with an F-18 label should provide higher image quality than a SPECT agent. 

Dr. Gary Heller of Morristown Medical Center in New Jersey, co-author of the study and a past president of ASNC, noted, "I am impressed by the image quality in this study. Fatty acid imaging represents an exciting potential option for evaluating the heart, and may be a factor in advancing the science. I believe the data presented at this year's ASNC meeting confirms the emergence of PET as an important force in cardiac molecular imaging."

Thijs Spoor, Chairman and CEO of FluoroPharma commented, "We are very pleased that this abstract was one of the few selected for oral presentation at the Annual Scientific Session of ASNC. The data presented by Dr. Cerqueira further supports findings presented earlier this year at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mid-Winter Meeting, and at the SNMMI Annual Meeting on image quality and quantitation. The data presented at ASNC bolsters our confidence as we move forward with the completion of the full study. We believe a product like CardioPET could be an important development for healthcare professionals and their patients with coronary disease. We are looking forward to the next steps in advancing CardioPET's clinical development."

About CardioPET and the Phase II Trial

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.

Editor's Notes

Co-authors on this presentation include Gary V. Heller, MD, PhD (Morristown Hospital, New Jersey, USA); Veronique Roelants, MD, PhD, Fabian Demeure, MD, PhD, David Vancraeynest (Cliniques universitaires Saint-Luc, Louvain, Belgium); Olivier Gheysens, MD, PhD (KU Leuven, Belgium); Roland Hustinx, MD, PhD, Luc Pierard, MD, PhD (Centre Hospital Universitae de Liege, Belgium); and Edward Ficaro, PhD, (University of Michigan, Ann Arbor, USA).

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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