Preliminary clinical findings indicate that when used with PET technology, Lantheus Medical’s PET Myocardial Perfusion Imaging Tracer demonstrates a favorable radiation dosimetry profile and is generally well-tolerated, according to phase I data presented during the Society of Nuclear Medicine (SNM) conference in New Orleans.
The data, presented by the principal investigator, Jamshid Maddahi, MD, showed high myocardial uptake that was stable over time with favorable myocardial to background ratios. The findings will be further expanded on in subsequent studies, Maddahi said.
The Phase I clinical trial was designed to estimate radiation dosimetry of a single dose of BMS747158 in healthy subjects at rest. Secondary objectives included assessing human safety, tolerability and biodistribution. Thirteen subjects were injected with 150-260 MBq of BMS747158 intravenously at the University of California, Los Angeles.
Whole body imaging using PET technology was conducted for five hours to collect data for radiation dosimetry calculation. Extensive safety monitoring was conducted with clinical labs, ECG, EEG, neurological, heart rate and blood pressure assessment at several time points during the study, the researchers said.
According to the results of the first in human, Phase I study, intravenous injection of BMS747158 was safe and well-tolerated with no adverse events reported. Mean effective dose was 0.073 rem/mCi, with standard deviation of 12 percent. Biodistribution results showed high myocardial uptake with favorable target to background ratios. Although non-optimized, heart imaging data collected over the first 10 minutes demonstrated that BMS747158 used in combination with PET imaging could provide high quality cardiac images, the authors noted.
“We are encouraged by these preliminary findings about the safety and biodistribution profile of BMS747158 which illustrate its potential in myocardial perfusion PET imaging as we move to the next phase of the clinical development process,” said D. Scott Edwards, vice president, global research and development, Lantheus. “We remain committed to investing in the field of nuclear cardiology and developing innovative imaging agents that give physicians improved options for diagnosing and managing their patients.”