BFPET Pre-Phase 2 Study Results Very Encouraging
Brian Marckx, CFA
FluoroPharma Medical (FPMI) announced yesterday (7/26/2012) 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". All 20 patients are expected to be imaged by early Q4. This study is similar in the expected design of the soon-to-commence 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.
Alan Fishman, principal investigator of the BFPET phase I trial (completed in 2008), notes in the press release relative to the current study that "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."
We view this as an obvious towards development of BFPET, which we think could enter phase II by the current year-end and complete sometime next year. 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.
We cover FPMI with an Outperform rating and $2.00/share price target.
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