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). Product Candidates BFPET (18-F TPP) The company’s BFPET program has 18F-labeled cationic lipophilic tetraphenylphosphonium ion (18-F TPP) as an imaging agent designed for use in stress-testing for patients with presumptive or proven CAD. 18-F FTPP measures the extent and severity of cardiovascular disease through the detection of ischemic (such as reversible and viable) and infarcted (irreversibly damaged) myocardial (heart) tissue. Its mechanism of action allows it 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 FTPP completed a Phase I 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 2016. 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 blood flow and metabolism in patients with CAD, including patients unable to perform exercise cardiac stress-testing. 18-F FCPHA allows for the potential detection of ischemic (reversible and viable) and infarcted (irreversibly damaged) myocardial tissue in patients with presumptive or proven acute and chronic CAD and related cardiac diseases. In addition, 18-F FCPHA could be used for assessing myocardial viability for the prediction of improvement prior to and/or following revascularization in patients with acute CAD, including myocardial infarction (heart attack). 18-F FCPHA allows for the identification of compromised 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 assessing myocardial metabolism and viability. The safety and tolerability of 18-F FCPHA have been demonstrated in a Phase I trial conducted at the Massachusetts General Hospital. Enrollment in a Phase IIa trial has been completed at four sites in Belgium to assess its safety and efficacy in CAD patients. This Phase IIa study was an open label trial designed to assess the safety and diagnostic performance of 18-F FCPHA compared with standard-of-care myocardial perfusion imaging, and angiography as a gold standard of epicardial coronary artery disease. The final safety and efficacy analysis is ongoing. 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 clinical research services agreements with SGS Life Science Services, Biomedical Systems, and MERGE eCLinical OS for clinical research services relating to its CardioPET Phase II study to assess myocardial perfusion and fatty acid uptake in CAD patients. The company maintains clinical research agreements with Pharmaceutical Product Development, LLC and Cardiovascular Imaging Technologies, clinical research organizations engaged in the business of managing clinical research programs and providing clinical development and other related services, for the 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 in 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
The information and data displayed in this profile are created and managed by S&P Global Market Intelligence, a division of S&P Global. Bloomberg.com does not create or control the content.
|No competitor information is available for FPMI.|
|View Industry Companies|
|Price/Cash Flow||NM||Not Meaningful|
Sponsored Financial Commentaries
Only a company representative may request an update for the company profile. Documentation will be required.
To contact FLUOROPHARMA MEDICAL INC, please visit www.fluoropharma.com. Company data is provided by S&P Global Market Intelligence. Please use this form to report any data issues.