developing breakthrough cardiovascular molecular imaging agents for the
Positron Emission Tomography (PET) market, announced commencement of Phase
I clinical trials for BFPET, following institutional review board (IRB)
approval of the proposed studies. The Phase I trial is a single center,
open label study, designed to evaluate safety, distribution and dosimetry
of BFPET as a PET tracer for myocardial perfusion imaging in healthy
subjects. The study will be led by Dr. Alan Fischman, Professor of
Radiology at Harvard Medical School and former Director of the Nuclear
Medicine Division at Massachusetts General Hospital. BFPET is
FluoroPharma's second cardiovascular PET agent to enter clinical trials.
BFPET is a PET blood flow imaging agent, for use in classic
"rest-stress" cardiac testing. More than 9 million Americans each year
undergo myocardial perfusion imaging, the standard test to assess coronary
artery disease (CAD). BFPET, as a PET imaging tracer, may have a
significant advantage due to its potential to improve the sensitivity and
specificity of CAD diagnosis and to provide information on myocardial
mitochondrial damage. "This agent, if successful, should improve CAD
diagnosis and follow-up of therapy and intervention, and broaden the
utility of PET as an imaging modality," said Dr. David Elmaleh,
FluoroPharma's Chairman and Scientific Founder. "BFPET has performed well
in animals with a target-to-blood ratio of 70:1, and we look forward to
evaluating the agent in human studies."
"We are delighted to have our second product enter clinical trials,"
said Dr. Ljiljana Kundakovic, FluoroPharma's President. "BFPET's progress
follows on the tail of CardioPET, an agent for the detection of metabolic
integrity of the heart, which recently completed a Phase I safety
evaluation in normal healthy volunteers and cardiac patients. FluoroPharma
has the potential to significantly impact diagnosis of cardiovascular
disease with multiple PET imaging agents targeting a wide range of
indications."
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. fluoropharma
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.
FluoroPharma Inc.
fluoropharma
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