SOURCE: FluoroPharma Medical, Inc.

FluoroPharma Medical, Inc. Logo

December 04, 2014 11:00 ET

FluoroPharma Medical Announces Scheduled Completion of Enrollment in a Phase II Clinical Trial of CardioPET (18F FCPHA) for Assessment of Coronary Artery Disease (CAD)

MONTCLAIR, NJ--(Marketwired - December 04, 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 enrollment for this Phase II trial will be closing on December 15th . To date, FluoroPharma believes it has acquired sufficient patient data allowing for the assessment of the pharmaceutical's safety and quality of FCPHA generated cardiac images in humans.

According to Thijs Spoor, Chairman and CEO of FluoroPharma, "This trial has so far produced data on image quality, the optimal time for imaging after injection, and preliminary data on myocardial blood flow. To date, no major adverse events have been seen with any patients dosed with CardioPET. As we plan for the next development steps, all of this data will now be incorporated into a thorough assessment versus other clinical comparators of SPECT and angiography. It is expected that the full data will be evaluated in a blinded read fashion and then presented early next year." Mr. Spoor continues, "This is a major milestone for the company. We are encouraged by our progress to date, and believe that CardioPET potentially signals a compelling new direction for PET cardiac imaging at a time when healthcare professionals around the world could benefit from novel diagnostic imaging that expand and improve their diagnostic capabilities. Symptomatic coronary artery disease affects millions of patients worldwide and accounts for the significant increase in mortality."

This Phase II clinical trial is an open label study designed to assess the safety and diagnostic performance of CardioPET (18F FCPHA) as compared to currently utilized SPECT myocardial perfusion imaging agents and angiography, the traditional standard of care for establishing the presence of obstructive CAD. The trial allows the company to evaluate the dynamics and performance of fatty acid markers in patients under variable conditions: at rest or with induced stress. This multicenter study was conducted in Belgium.

CardioPET (18F FCPHA), 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. FluoroPharma believes its pharmacokinetic characteristics could be especially valuable in patients who are unable to exercise. There is no commercially available fatty acid analog marker in the U.S. or Europe, where coronary disease is a major problem.

Olivier Gheysens, MD, PhD, the principal investigator for the entire study, noted, "Fatty acid metabolism is affected in various degrees by the presence of coronary disease. Under normal conditions, free fatty acids are the heart's main energy source. With reduction in blood flow to the myocardium, it switches its metabolism to glucose. The myocardium will switch back to fatty acid metabolism when blood flow is restored and if the myocardium has not been permanently damaged. CardioPET has the potential to evaluate the degree to which the myocardium has been affected."

A traceable fatty acid marker such as CardioPET will allow the evaluation of cardiac blood flow as well as the dietary preference of the cardiac muscle under stress or at rest which is an indicator of the metabolic state of the heart, ergo cardiac muscle viability. The ability to evaluate cardiac viability provides a significant advantage in comprehensive assessment of CAD in comparison to the currently utilized methods which focus mainly on hemodynamics alone.

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 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.

Contact Information