Massachusetts General Hospital Selected as Trial Site for Next Generation Diagnostic Agent for Use in Patients with Coronary Artery Disease
MONTCLAIR, NJ– 01/03/13 — 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 Phase II Clinical trials will be conducted at Massachusetts General Hospital for BFPET™(18)F-TPP, the company’s imaging agent under evaluation for measuring cardiovascular blood flow.
BFPET has the potential for producing images with clear diagnostic qualities as well as increased resolution. The greater sensitivity will provide doctors with earlier and more accurate information for more effective patient management.
Thijs Spoor, Chairman, CEO and President of FluoroPharma Medical, commented, “Today’s announcement marks another step forward for FluoroPharma in helping to define the future for diagnostic imaging procedures. We are very pleased that our Phase II trials for BFPET will be developed at such a prestigious institution as the Massachusetts General Hospital. This news follows previous announcements of our Phase II trials in Brussels on CardioPET™ (FCPHA), another of our first in class diagnostic agents for the detection and assessment of acute and chronic forms of coronary disease. This trial has now started and we are looking forward to seeing interim results in the near future. Massachusetts General Hospital has been instrumental in our Phase I studies and we are excited that this relationship will continue. We believe that imaging agents like BFPET and CardioPET, will provide Cardiologists around the world with faster, more accurate diagnostic tools with increased sensitivity for the detection and assessment of acute and chronic CAD. Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and cardiovascular diseases are leading causes of death and disability in the world.”
The Phase II trial for BFPET is an open label study designed to assess the safety and diagnostic performance of BFPET. Results are expected over the next six months.
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 positron emission tomography (PET) imaging agents and is advancing two products in clinical trials for assessment of acute and chronic forms of coronary disease. These first in class agents have been designed to rapidly target myocardial cells. Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, agents with the potential to image Alzheimer’s disease and 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, Finland, Portugal, Ireland and Mexico.
For more information on the Company, please visit: www.fluoropharma.com
BFPET, a Flourine-18 labeled tracer, has been designed to enter the myocardial cells in direct proportion to blood flow and cell membrane potential. These are two of the most important physiological indicators upon which adequate blood supply to the heart depends. BFPET has been designed to differentiate among those cells of the myocardium that may be ischemic, infarcted and those that are healthy.
Ischemic and infarcted cells should take up less BFPET than healthy myocardial cells. The signal emitted by BFPET should be inversely proportional to the extent of myocardial injury. Therefore, FluoroPharma believes that ischemic heart tissue can be reliably detected by using BFPET.
CardioPET is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body. FFAs are the major source of energy for healthy myocardium, where they are transported into the mitochondria and are then metabolized via beta-oxidation. CardioPET has completed Phase I studies where it was well tolerated and did not induce any adverse events or clinically significant deviations in laboratory values. The total radiation exposure was minimal and well within safety limits.
About Coronary Artery Disease (CAD)
Coronary Artery Diseases are the number one cause of death globally: more people die annually from CADs than from any other cause. More than 16 million people alive today have a history of heart attack, angina pectoris (chest pain) or both. It is also estimated that by 2030, this number will almost double and CADs will remain the single leading cause of death.
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.
FluoroPharma Medical, Inc.
Cameron Associates, Inc.
Released January 3, 2013