QuantRx Biomedical, a diagnostics company, and FluoroPharma, a company developing cardiovascular molecular imaging agents for the PET market, presented positive Phase I safety results for CardioPET.
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).
David Elmaleh, MD, chairman and founder of FluoroPharma, presented findings from the Phase I trial at the Clinical Trials Update session at the Society of Nuclear Medicine conference in Denver.
CardioPET is a metabolic cardiac PET imaging agent that allows assessment of acute and chronic CAD while patients are at rest, according to the Doylestown, Pa.-based QuantRx. FluoroPharma said it anticipates that CardioPET may be an alternative to 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, and professor of radiology at Harvard Medical School. "CardioPET performed well in both healthy volunteers and patients with CAD."
"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," said H. William Strauss, MD, the trial's medical monitor.