FluoroPharma Announces That Data From Its Phase II Clinical Trial of 18-F FCPHA (CardioPET) Was Presented at the Society of N...
June 11 2014 - 9:47AM
Marketwired
FluoroPharma Announces That Data From Its Phase II Clinical Trial
of 18-F FCPHA (CardioPET) Was Presented at the Society of Nuclear
Medicine and Molecular Imaging Annual Meeting, June 10th in St.
Louis, MO
Phase II Progress for CardioPET Is Encouraging; Expands on Data
Presented at Mid-Winter Meeting
MONTCLAIR, NJ--(Marketwired
- June 11, 2014) - 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 new Phase II trial data related to its CardioPET
clinical trial was presented at the Society of Nuclear Medicine and
Molecular Imaging Annual meeting (SNMMI), held in St. Louis,
MO.
Data from a feasibility study on the quantification of
myocardial perfusion in humans by PET/CT utilizing the fatty acid
analogue 18F-FCPHA (CardioPET) were presented by the principal
investigator, Olivier Gheysens, MD, PhD. According to Dr.
Gheysens, "Our aim in this pilot study was to evaluate CardioPET
uptake in our subject population, to address the potential for
quantification. We analyzed the input functions and generated
time-activity curves across 17 myocardial segments. Our analysis
suggests that relative and quantitative blood flow measurements may
be feasible with this tracer."
The study was conducted at the University Hospital Leuven,
Belgium. Collaborators on this study include Olivier Gheysens, MD,
PhD, Andrey Postnov, PhD, Johan Nuyts, PhD, Koen Van Laere, MD,
PhD, DrSc (Department of Nuclear Medicine & Molecular Imaging,
University Hospital Leuven, Belgium), Stefan Janssens, MD, PhD
(Department of Cardiology, University Hospital Leuven, Belgium) and
Manuel Cerqueira, MD (Department of Nuclear Medicine, Cleveland
Clinic, Cleveland, Ohio USA.)
Thijs Spoor, Chairman and CEO of FluoroPharma commented, "The
results are very encouraging for us, and builds on the safety and
image quality data presented at the SNMMI Mid-Winter meeting.
Quantification is an inherent strength of PET imaging. It provides
physicians with additional information which may be helpful in
making appropriate patient management decisions. We're now even
more excited about the potential of CardioPET."
About CardioPET and the Phase II Clinical Trial
18-F FCPHA (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 Phase II clinical trial is an open label study designed to
assess the safety and diagnostic performance of 18-F FCPHA
(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.
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
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
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 FluoroPharma Medical, Inc.
cperlman@fluoropharma.com Phone: 917-592-9260 Investor: Richard
Moyer Cameron Associates, Inc. richard@cameronassoc.comPhone: (212)
554-5466The Del Mar Consulting Group, Inc.Robert B.
PragPresident858-361-1786bprag@delmarconsulting.com
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