Clinical Trials

CardioPET

FluoroPharma completed the Phase I clinical trial for CardioPET in March 2008.  The trial enrolled 15 normal healthy volunteers and 6 subjects with CAD to evaluate safety, distribution and dosimetry of CardioPET as a PET tracer for myocardial imaging.  The trial was a single center, open label study led by Principal Investigator Alan J. Fischman, MD, PhD at the Massachusetts General Hospital.

The CardioPET trial achieved all safety endpoints with no adverse events or clinically significant changes noted in follow-up clinical and laboratory testing.  The agent had rapid extraction from blood with sustained levels in myocardium.  CardioPET performed well in both healthy volunteers and patients with CAD.

Analysis by H. William Strauss, MD, the trial’s medical monitor, suggests that CardioPET has promise as a PET agent for assessing integrity of the heart.  The CardioPET images showed good contrast between lesion and normal myocardium, and compared to SPECT, may be superior in quality.

BFPET

FluoroPharma completed the Phase I clinical trial for BFPET in July 2008.  The trial enrolled 12 normal healthy volunteers to evaluate safety, distribution and dosimetry of BFPET as a PET tracer for myocardial imaging.  Myocardial perfusion imaging is a standard test to assess coronary artery disease (CAD), with more than 9 million Americans undergoing the test annually.  The trial was a single center, open label study led by Principal Investigator Alan J. Fischman, MD, PhD at the Massachusetts General Hospital.

The BFPET trial achieved all safety endpoints with no adverse events or clinically significant changes noted in follow-up clinical and laboratory testing.  The agent has a favorable dosimetry and pharmacokinetics profile and is well tolerated.  Biodistribution results indicate fast blood clearance, rapid and stable myocardial uptake and high heart to background ratios.