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News

FluoroPharma sees positive safety results from Phae 1 trial of CardioPET

FluoroPharma : 05 March, 2008  (New Product)
FluoroPharma has announced positive Phase I safety results for CardioPET in a trial 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, Colorado, USA.

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.

Strauss said: 'The promise of utilising PET imaging with a fatty acid analogue 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.'
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