FluoroPharma Announces Positive Phase I Safety Results for BFPET, Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography (PET)
BOSTON, July 23, 2008 /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 . "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 . "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."
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.
CONTACT: Ljiljana Kundakovic of FluoroPharma Inc., +1-617-482-2333, ext.16
Web site: http://www.fluoropharma.com/
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Posted: July 2008