By Brian Marckx, CFA Promising Phase II Data Reinforces Our Confidence in CardioPET CardioPET enters the myocardium similar to the way of fatty acids and remains there long enough to allow for PET imaging. The images also showed that fatty acid uptake decreased over time. In ischemic heart conditions, uptake of fatty acids is reduced, which would be expected in these patients.
Data and images from FluoroPharma's (OTC BB:FPMI) ongoing phase II trial of its novel imaging agent, CardioPET, were presented yesterday (2/6/2014) at the Society of Nuclear Medicine and Molecular Imaging Meeting in Palm Springs, CA
As a reminder, CardioPET is being developed as a PET imaging agent to better diagnose acute and chronic coronary artery disease (CAD) in patients that can not undergo stress testing, among other potential indications. The Belgian-based phase II trial is an open label study designed to assess safety and performance of CardioPET compared to SPECT myocardial perfusion imaging (MPI) agents and angiography.
The study's focus is assessment of both myocardial perfusion and myocardial fatty acid uptake. The data presented yesterday relate to assessment of the safety of CardioPET, image quality and in determination of the optimal timing for PET imaging after injection. Future data from the study will compare results to that of SPECT myocardial perfusion imaging agents.
Fifteen patients with known or suspected coronary artery disease were included in the analysis. Images were taken in three to five minute durations at intervals of one to ten minutes and at 15, 30, 45 and 55 minutes after injection. Image quality was graded as either optimal, sub-optimal or non-interpretable. Changes in blood pool activity, liver activity and delineation defects over time were recorded.
Relative to safety, there were no adverse events and no other safety issues related to CardioPET (one patient had a panic attack from being in the imaging system). Relative to quality of the images and performance of CardioPET, images at all time points from three minutes following injection were considered excellent. Blood pool activity began to decline in the initial one to three minute timeframe and blood pool clearance was totally completed in all patient at five minutes (image below). Rapid blood pool clearance is beneficial as it allows for imaging shortly following injection and reduces patient exposure to imaging radiation.
The interim data, image quality and safety was considered very promising. The ability to attain high quality images very shortly after injection is of particularly benefit and significant. We expect there will be additional data and images presented in the near-term and expect similarly positive results. This interim data reinforces our belief that CardioPET has potential to unseat the current standard imaging agents for coronary artery disease imaging, particularly for those patients unable to undergo stress testing.
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Promising Phase II Data Reinforces Our Confidence in CardioPET
CardioPET enters the myocardium similar to the way of fatty acids and remains there long enough to allow for PET imaging. The images also showed that fatty acid uptake decreased over time. In ischemic heart conditions, uptake of fatty acids is reduced, which would be expected in these patients.