FluoroPharma Medical, Inc., a biopharmaceutical company, engages in discovering, developing, and commercializing molecular imaging pharmaceuticals with initial applications in the area of cardiology. The company’s initial focus has been on the development of novel cardiovascular imaging agents that could detect and assess acute and chronic forms of coronary artery disease (CAD). The company has two clinical-stage molecular imaging pharmaceutical product candidates, such as 18-F TPP (BFPET) and 18-F FCPHA (CardioPET). Additionally, the company has identified potential candidates that might be useful in the detection and/or treatment of vulnerable plaque. Product Candidates BFPET (18-F TPP) The company’s BFPET program has ((18F)-labeled cationic lipophilic tetraphosphonium, 18-F TPP) as an imaging agent designed for use in stress-testing for patients with known or suspected CAD. 18-F TPP measures the cardiovascular blood flow through the detection of ischemic (reversibly damaged) and infarcted (irreversibly damaged) myocardium (heart) tissue. Its mechanism of action is to enter the myocardial cells of the heart muscle in direct proportion to blood flow and membrane potential--the most important indicators of adequate cardiac blood supply. 18-F TPP completed a Phase Ia clinical trial in 12 healthy volunteers with no adverse events and no clinically significant changes noted in follow-up clinical and laboratory testing. The results of the trial demonstrated the required dosimetry, safety profile and high resolution myocardial imaging pharmacokinetics to justify a controlled Phase II clinical trial. The company has announced that it would begin Phase II trials at Massachusetts General Hospital to assess its efficacy in CAD subjects; and expects actual enrollment to commence in the first half of 2015. CardioPET (18-F FCPHA) The company’s CardioPET program has (Trans-9-(18F)-Fluoro-3, 4-Methyleneheptadecanoic Acid, 18-F FCPHA) as a molecular imaging agent designed to assess myocardial metabolism for patients with CAD. 18-F FCPHA allows for the potential detection of ischemic (reversibly damaged) and infarcted (irreversibly damaged) myocardium (heart) tissue in patients with known or suspected acute and chronic CAD. In addition, 18-F FCPHA could be used for cardiac viability assessment (CVA) for the prediction of improvement prior to and/or following revascularization in patients with acute CAD, including myocardial infarction, or heart attack). 18-F FCPHA allows for the identification of damaged but viable heart tissue, which is important since revascularization in those patients with substantial viable myocardium results in improved left ventricular function and survival. 18-F FCPHA is designed to provide the metabolic component for CVA. The safety and tolerability of 18-F FCPHA have been demonstrated in a Phase I trial conducted at the Massachusetts General Hospital. Enrollment in Phase II trials has been completed at four sites in Belgium to assess its safety and efficacy in CAD patients. The Phase II clinical trial plan for 18-F FCPHA is an open label trial designed to assess the safety and diagnostic performance of 18-F FCPHA as compared to myocardial perfusion imaging and angiography as a gold standard of background disease. Strategic Alliances and Commercial Agreements The company has two exclusive technology licenses with Massachusetts General Hospital, which the company entered in 2014 (collectively, the ‘Agreements’). The Agreements provide exclusive licenses for the company’s two major product candidates, BFPET and CardioPET. The company has a clinical research services agreement with SGS Life Science Services (SGS), a company with its registered offices in Belgium, for clinical research services relating to the company’s CardioPET Phase II study to assess myocardial perfusion and fatty acid uptake in CAD patients. In 2014, the company entered into a master services agreement with PPD Development, LP, a clinical research organization engaged in the business of managing clinical research programs and providing clinical development and other related services, for the clinical research services relating to the BFPET Phase II study. Intellectual Property The company has obtained the licenses to its patents and patent applications from Massachusetts General Hospital, the patent assignee in each case. The issued patents covering the company’s 18-F FCPHA and 18-F TPP technologies include both composition and method of use patents within the field of diagnostic cardiology that expire at various dates between December 2016 and February 2025. Governmental Regulations The company is required to maintain and provide updated safety and efficacy information to the United States Food and Drug Administration. History FluoroPharma Medical, Inc. was founded in 2003.
fluoropharma medical inc (FPMI:OTC US)
8 Hillside Avenue
Montclair, NJ 07042
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