BFPET Phase II Trials Commence
By Brian Marckx, CFA
FluoroPharma (OTC BB:) announced today that Phase II trials for its novel imaging agent BFPET have now commenced and are being conducted at Massachusetts General Hospital. This is commensurate with the timelines that the company previously outlined.
BFPET is a novel blood flow imaging agent being developed for use in conjunction with stress-testing for the detection of ischemic (reversibly damaged) and infarcted (irreversibly damaged) tissue within the myocardium in patients with suspected or proven chronic CAD. BFPET, a Flourine-18 labeled tracer, has been designed to enter the myocardial cells of the heart muscle in direct proportion to blood flow and membrane potential - which are the two most important physiological indicators of adequate blood supply to the heart. BFPET has been designed to effectively differentiate among those cells of the myocardium that are ischemic, infarcted and those that are healthy. Because ischemic and infarcted cells take up significantly less BFPET than normal healthy myocardial cells, the signal emitted by BFPET is inversely proportional to the extent of myocardial injury. Therefore, as a result of BFPET’s use, FluoroPharma believes ischemic heart tissue can be more reliably detected using BFPET. BFPET is expected to primarily be used in conjunction with stress-testing for patients with suspected or proven chronic CAD. If approved, BFPET will represent the first molecular imaging blood flow agent commercialized for use in the cardiovascular segment of the PET imaging market.
Phase I trials (used to assess safety / tolerability, distribution and dosimetry) consisted of 12 healthy individuals which were injected with one dose of BFPET while at rest (i.e. - not stressed-tested). Results, announced in July 2008, showed a favorable profile on all categories (safety, distribution, dosimetry) and no adverse events were experienced.
In late July 2012 FlouroPharma announced that quality of the initial images using BFPET in a 20-patient (with coronary artery disease) investigator-led stress perfusion imaging study conducted at a hospital in Beijing China were "spectacular" and "superb". This study is similar in the design of the now commenced phase II study where BFPET will be compared to Rb-82 and/or traditional SPECT agents such as sestamibi which suffer from certain drawbacks such as high cost or comparably (relative to BFPET) lower image quality.
We cover FPMI with an Outperform rating and $2.35/share price target. Our full 20-page report on the company which includes a detailed description of FPMI's novel cardiac tracer agents including BFPET and their respective potential competitive advantages and market opportunities can be viewed here.
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