FluoroPharma Medical Announces Internal Review of Currently Acquired Imaging Data From Phase II Study for CardioPET(TM) (FCPHA)
June 20 2013 - 8:03AM
Marketwired
MONTCLAIR, NJ--(Marketwired -
June 20, 2013) - 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, is pleased with currently acquired imaging data from
its ongoing Phase II clinical trial for CardioPET™ (FCPHA) to
assess myocardial perfusion and fatty acid uptake in coronary
artery disease (CAD) patients.
CardioPET, one of FluoroPharma's first in class PET imaging
products, is a perfusion and 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.
The ongoing Phase II clinical trial is an open label study
designed to assess the safety and diagnostic performance of
CardioPET as compared to currently utilized SPECT myocardial
perfusion imaging agents and angiography, the current "gold
standard." This multicenter study is being conducted in
Belgium.
In February, the company announced that the first acquired
images indicated high resolution in the heart and provided
extremely clear image quality. The company's recent internal review
of additional data collected further supports these initial
findings in both arms of the trial. Based on the rate of patient
enrollment, a quantitative assessment of the data is expected later
this summer.
According to Dr. Manuel D. Cerqueira, Chairman, Department
of Nuclear Medicine at the Cleveland Clinic, "The images thus far
obtained from CardioPET indicate excellent image quality. The
immediate acquisition of images will be very efficient for patient
work flow."
Thijs Spoor, Chairman and CEO of FluoroPharma Medical,
commented, "The ability to obtain images quickly has the potential
to enhance the value of CardioPET in view of the current standard
of care, which can take considerable time. It is becoming
increasingly clear that novel diagnostic imaging agents are
urgently needed and we are focused on driving forward the
development of our pipeline to provide healthcare professionals
around the world with new products that expand and improve their
diagnostic capabilities. We are encouraged with the data from our
ongoing CardioPET trial and look forward to obtaining the interim
results this summer. Our intention is to present CardioPET interim
findings at a major medical conference later this year."
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 artery 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 brain tissue affected by 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
About CardioPET
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 Disease (CAD) is a leading cause of death and
disability globally. The World Health Organization (WHO) estimated
that more than 17 million people have died from heart attack,
angina pectoris (chest pain) or both. It is also estimated that by
2030, this number will almost double.
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.
CONTACT: Media: Carol PerlmanFluoroPharma Medical, Inc.
cperlman@fluoropharma.comPhone: 917-592-9260Investor Relations:
Richard Moyer Cameron Associates, Inc. Richard@cameronassoc.com
Phone: 212-554-5466
FluoroPharma Medical (CE) (USOTC:FPMI)
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