FPMI: CardioPET Excellent Image Quality from Phase
By Brian Marckx, CFA
This morning (2/28/2013)
FluoroPharma (OTC BB:
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
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
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.
for additional information on our research and coverage universe,
to receive our articles and reports emailed directly to you each
FLUOROPHARMA MD (FPMI): Get Free Report
To read this article on Zacks.com click here.