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FPMI: CardioPET Excellent Image Quality from Phase II
By Brian Marckx, CFA
This morning (2/28/2013) FluoroPharma (OTC BB:(FPMI)) announced that the initial images from phase II trials of their CardioPET imaging agent candidate "show high resolution in the heart and provides extremely clear image quality". 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.
FPMI moved CardioPET into phase II following positive results from phase I trials (used to assess safety / tolerability) which consisted of 6 patients with diagnosed CAD and 15 normal healthy volunteers (i.e. - control group). Phase I testing completed in April 2007 and demonstrated CardioPET was safe with no patients experiencing any adverse events.
FPMI brought on SGS Life Sciences to provide clinical research services for phase II trials which commenced late in 2012. The Belgian-based phase II trial is an open label study designed to assess safety and performance of CardioPET compared to myocardial perfusion imaging (MPI) and angiography. The trial is being conducted at two sites in Belgium. Total enrollment is expected to consist of between 30 and 100 patients with known stable chronic coronary artery disease that can not undergo stress testing.
In this morning's press release Dr. Roland Hustinx, one of the investigators in the study, notes, "The (phase II) images obtained from CardioPET are high quality and agree with previous findings." FPMI notes that they expect to have results over the next six months.
We view this morning's news as an obvious and significant positive for FPMI and their CardioPET candidate and our outlook remains highly positive on FPMI. If all goes to plan phase II will wrap up in 2013 and phase III completed and an NDA filing potentially happening by the end of 2015. U.S. launch could potentially happen by 2016.
We cover FPMI with an Outperform rating and $2.35/share price target. Our full 20-page report on FPMI is available for free here.
As a reminder, FPMI has another PET imaging agent candidate in phase II trials. BFPET is FPMI's 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. In July and November 2012 FPMI announced image results from a 20-patient investigator-sponsored clinical trial conducted in China where patients with CAD were imaged using BFPET.
Alan Fishman, principal investigator of the BFPET phase I trial (completed in 2008), commented on the initial results of the China-based study released in July, noting that the "initial results are impressive. Image quality obtained using PET is superb. BFPET shows clear diagnostic qualities as well as increased resolution, inherent in PET. The initial images look spectacular and we are confident that when all the patients are imaged, the data will further support clinical development of the agent." His confidence was further bolstered when additional data was available in November, noting "We saw a high level of agreement between the angiography, the SPECT and the BFPET images. These additional images demonstrate that BFPET shows clear diagnostic qualities as well as the increased resolution, inherent in PET."
In early January FPMI announced that phase II trials of BFPET are being conducted at Massachusetts General Hospital. Similar to the investigator-led study, the phase II study will compare BFPET 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 think that if all goes to plan, phase III trials could wrap up and an NDA filed by the end of 2015. This potentially puts BFPET on the U.S. market by 2016/2017.
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