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news.Lantheus Medical Imaging has reported Phase I data relating to the safety and tolerability in human subjects of BMS747158, its novel fluorine 18-labeled positron emission tomography tracer for myocardial perfusion imaging.
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The preliminary clinical findings indicate that when used with PET technology, BMS747158 demonstrates a favorable radiation dosimetry profile and is generally well-tolerated. Exploratory analyses from this study showed high myocardial uptake that was stable over time with favorable myocardial to background ratios.
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.
Approximately 13 subjects were injected with 150-260MBq of BMS747158 intravenously at University of California, Los Angeles. Whole body imaging using positron emission tomography (PET) technology was conducted for five hours to collect data for radiation dosimetry calculation.
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.
Scott Edwards, vice president of global R&D at Lantheus Medical Imaging, said: “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.”