BOSTON, March 3 /PRNewswire/ -- FluoroPharma Inc., a company developing breakthrough cardiovascular molecular imaging agents for the Positron Emission Tomography (PET) market, announced positive Phase I safety results for CardioPET, the company's lead product.
The trial was designed to evaluate safety, distribution and dosimetry of CardioPET as a PET tracer for myocardial imaging in healthy subjects and patients with Coronary Artery Disease (CAD). Dr. David Elmaleh, Chairman and scientific founder of FluoroPharma, presented findings from the Phase I trial at the "Clinical Trials Update" session at a Society of Nuclear Medicine conference in Denver, CO.
CardioPET is a novel metabolic cardiac PET imaging agent that allows assessment of acute and chronic coronary artery disease while patients are at rest. FluoroPharma anticipates that CardioPET may be an accurate alternative to standard treadmill stress-testing and for patients that are unable to exercise.
"The CardioPET trial achieved all safety endpoints and experienced no safety issues," said Alan J. Fischman, MD, PhD, Principal Investigator of the CardioPET study. "CardioPET performed well in both healthy volunteers and patients with CAD." Dr. Fischman is a Professor of Radiology at Harvard Medical School and the former Director of Nuclear Medicine at Massachusetts General Hospital.
H. William Strauss, MD, the trial's medical monitor, was also optimistic about CardioPET's potential. "The promise of utilizing PET imaging with a fatty acid analog such as CardioPET to assess integrity of the heart encompasses a wide range of potential indications, and we look forward to validating CardioPET's continued safety in Phase II clinical trials. The PET technology we are studying today shows early promise and may hold the key to better quality CAD diagnoses." Dr. Strauss is the Clinical Director of Nuclear Medicine at Memorial Sloan Kettering Cancer Center and Professor of Radiology at Cornell University's Weill School of Medicine.
"The FluoroPharma team is pleased and encouraged by the Phase I results of the company's lead product," said Ljiljana Kundakovic, PhD, President of FluoroPharma. "We look forward to advancing two other cardiovascular PET molecular imaging agents -- BFPET for assessment of myocardial perfusion and VasoPET for assessment of atherosclerotic plaque formation."
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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