July 24, 2008
QuantRx Reports Positive Phase I Results of Myocardial Imaging Tracer
QuantRx Biomedical has announced that the company's FluoroPharma has achieved positive Phase I results for BFPET, its novel Fluorine-18 labeled tracer for myocardial perfusion imaging.
The Phase I trial was designed to evaluate safety, distribution and dosimetry of BFPET in 12 healthy subjects following a single dose injection at rest.BFPET is FluoroPharma's second cardiovascular product to complete Phase I clinical development. BFPET is a positron emission tomography (PET) imaging agent, designed to assess the blood flow in the heart (myocardial perfusion).
Fischman, professor of Radiology at Harvard Medical School, said: "BFPET Phase I data demonstrates that the agent has a favorable dosimetry and pharmacokinetics profile and is well tolerated. All safety endpoints were achieved with no adverse events and no clinically significant changes noted in follow-up clinical and laboratory testing. Biodistribution results indicate fast blood clearance, rapid and stable myocardial uptake and high heart to background ratios."
David Elmaleh, FluoroPharma's founder and chief scientific advisor, said: "The high quality cardiac images obtained in this study indicate that new cardiac PET imaging agents can expand the applications of PET beyond the use of FDG in oncology and neurology. With two cardiac agents in clinical development and a third in our pipeline, FluoroPharma hopes to pave the way for cardiovascular PET."