FluoroPharma Medical Announces Phase II Study for CardioPET
01 Mars 2012 - 4:15PM
FluoroPharma Medical, Inc. (OTCBB:FPMI), a company
specializing in the development of breakthrough diagnostic imaging
products that utilize positron emission tomography (PET) technology
to detect and assess pathology before clinical manifestation of
diseases, announces today that the company has recruited SGS Life
Science Services as the CRO for their Phase II study of CardioPET
to assess myocardial perfusion and fatty acid uptake in coronary
artery disease (CAD) patients has started.
CardioPET, one of FluoroPharma's first in class PET imaging
products, is a perfusion and fatty acid uptake indicator, which may
be used as a cardiac imaging agent that may be an accurate
alternative to standard treadmill stress-testing. This could be
especially valuable in patients who are unable to exercise.
The phase II trial will be an open label trial designed to
assess the safety and diagnostic performance of CardioPET as
compared to stress echocardiography, myocardial perfusion imaging
and angiography as a gold standard of background disease. Two trial
sites are planned in Belgium and results are expected in the second
half of 2012.
Thijs Spoor, President and Chief Executive Officer of
FluoroPharma Medical, added: "We are delighted to announce SGS Life
Science Services as the CRO for this phase II trial; a significant
milestone for FluoroPharma and our extraordinary pipeline of
products. Symptomatic coronary artery disease (CAD) affects
millions of patients worldwide and accounts for a significant and
increasing percentage of all deaths. It is clear that novel
diagnostic imaging agents are urgently required and we are focused
on driving forward the development of our pipeline to meet these
needs.
Commenting on the announcement, David Elmaleh, Chief Scientific
Officer of FluoroPharma Medical said, "We are very excited to be
initiating this Phase II study for CardioPET. CardioPET's
differentiated and superior imaging profile could have a
significant impact on the evaluation of CAD patients across the
spectrum of disease severity. Because CardioPET can detect
perfusion and fatty acid uptake insufficiency in the myocardium;
CardioPET could potentially be an accurate alternative to
stress-testing in patients with CAD."
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)
According to the American Heart Association more than 12 million
people alive today have a history of heart attack, angina pectoris
(chest pain) or both. The American Heart Association also estimates
that 1,100,000 Americans will have a new or recurrent coronary
attack this year – one-third of these patients will die making
coronary artery disease the single leading cause of death in
America today.
About FluoroPharma Medical
FluoroPharma is a biopharmaceutical company engaged in the
discovery and development of proprietary PET imaging products to
evaluate disease at the cellular and molecular levels. The Company
has licensed technology from the Massachusetts General Hospital in
Boston. FluoroPharma's goal is to enable personalized medicine
through advanced imaging products that will help the medical
community diagnose disease more accurately at the
earliest stages, leading to more effective treatment,
management and better patient outcomes.
The Company's initial focus is the development of breakthrough
positron emission tomography (PET) imaging agents for the efficient
detection and assessment of acute and chronic forms of coronary
artery disease (CAD). FluoroPharma 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.
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 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 Perlman
carol.perlman@cs-consultinggroup.com
917-592-9260
Investor Relations:
LHA
Kim Sutton Golodetz
kgolodetz@lhai.com
212-838-4568
FluoroPharma Medical (CE) (USOTC:FPMI)
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