FluoroPharma Announces Positive Phase I Safety Results for BFPET(TM), Myocardial...
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FluoroPharma Announces Positive Phase I Safety Results for BFPET(TM),
Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography
(PET)
BOSTON, July 23 /PRNewswire/ -- FluoroPharma Inc., a company developing
breakthrough molecular imaging agents for the Positron Emission Tomography
(PET) market, announced positive Phase I results for BFPET, its novel
Fluorine-18 labeled tracer for myocardial perfusion imaging. BFPET is
FluoroPharma's second cardiovascular product to complete Phase I clinical
development.
BFPET is a PET imaging agent, designed to assess the blood flow in the
heart (myocardial perfusion). Myocardial perfusion imaging is a standard test
to assess coronary artery disease (CAD), with more than 9 million Americans
undergoing the test annually. The Phase I trial, led by Principal Investigator
Alan J. Fischman, MD, PhD at the Massachusetts General Hospital, was designed
to evaluate safety, distribution and dosimetry of BFPET in 12 healthy subjects
following a single dose injection at rest.
"BFPET Phase I data demonstrates that the agent has a favorable dosimetry
and pharmacokinetics profile and is well tolerated. All safety endpoints were
achieved with no adverse events and no clinically significant changes noted in
follow-up clinical and laboratory testing," said Dr. Fischman, Professor of
Radiology at Harvard Medical School. "Biodistribution results indicate fast
blood clearance, rapid and stable myocardial uptake and high heart to
background ratios."
"We are encouraged by the positive initial clinical safety results and
look forward to validating BFPET's performance in the next stage of
development," said Dr. David Elmaleh, FluoroPharma's founder, Chief Scientific
Advisor, and Associate Professor of Radiology at Harvard Medical School. "The
high quality cardiac images obtained in this study indicate that new cardiac
PET imaging agents can expand the applications of PET beyond the use of FDG
(2-18Fluoro-2-deoxy-D-Glucose) in oncology and neurology. With two cardiac
agents in clinical development and a third in our pipeline, FluoroPharma hopes
to pave the way for cardiovascular PET."
"We are delighted to have reached this important clinical milestone as it
addresses the need for innovative agents that draw on the inherently superior
resolution of PET imaging compared to SPECT," said Dr. Kundakovic, President
of FluoroPharma. "There is tremendous opportunity for BFPET, as a PET
alternative in the SPECT dominated myocardial perfusion imaging market. The
use of BFPET in conjunction with PET technology holds the promise to better
quality CAD diagnosis."
About FluoroPharma
FluoroPharma is a molecular imaging company engaged in the discovery and
development of proprietary products for the PET market. FluoroPharma is
advancing three proprietary products for assessment of acute and chronic forms
of coronary disease. These agents have been designed to rapidly target either
the myocardial cells within the heart or inflamed plaques within the coronary
arteries. http://www.fluoropharma.com
This release may contain forward-looking statements within the meaning of
the federal securities laws. Such forward-looking statements reflect, among
other things, management's current expectations, plans and strategies, and
anticipated financial results, all of which are subject to known and unknown
risks, uncertainties and factors that may cause our actual results to differ
materially from those expressed or implied by these forward-looking
statements. Many of these risks are beyond our ability to control or predict
including the company's need for additional funds, the company's dependence on
a limited number of imaging compounds, the early state of the products the
company is developing, uncertainties relating to clinical trials and
regulatory reviews, competition and dependence on collaborative partners, the
company's ability to avoid infringement of the patent rights of others, and
the company's ability to obtain adequate patent protection and to enforce
these rights. Because of these risks, uncertainties and assumptions, you
should not place undue reliance on these forward-looking statements.
Furthermore, forward-looking statements speak only as of the date they are
made. FluoroPharma does not undertake any obligation to update or review any
such forward-looking information, whether as a result of new information,
future events or otherwise.
SOURCE FluoroPharma Inc.
Ljiljana Kundakovic of FluoroPharma Inc., +1-617-482-2333, ext. 16
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