BOSTON, March 19 /PRNewswire/ -- FluoroPharma Inc., a company 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."
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.|
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