BFPET Phase II Trials Commence
By Brian Marckx, CFA
FluoroPharma (OTC BB:
FPMI
)
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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