CLINICAL NEWS
Scientists Develop
New Imaging Technique to Simultaneously Detect All
Blood Clots in the
Body
Use of a combination of positron emission
tomography (PET) imaging and a fibrinbinding probe allowed clinicians to detect
thrombus throughout the entire body and
quickly identify the clot’s location, according to a study published in Arteriosclerosis,
Thrombosis, and Vascular Biology. The
approach was applied to a rodent model,
but the researchers, from Massachusetts
General Hospital (MGH), plan to test the
probe in humans later this year.
“The probe will
find blood clots
wherever they
occur, be that in
the venous system, the arteries,
the heart, or the
lungs.”
—PETER CARAVAN, PhD
Peter Caravan, PhD, a co-author
on the study and the co-director of the
Institute for Innovation in Imaging at
MGH, and researchers tested different
combinations of radioisotopes, peptides, and linkers to develop a method
that detects blood clots anywhere in the
body with a single whole-body scan.
The best-performing probe was the
fibrin binding probe 8, with copper-64
as the radiosotope. “Upon injection into
a vein, [the probe] will travel through
the body and find blood clots wherever they occur, be that in the venous
system, in the arteries, in the chambers
of the heart, or in the lungs,” the authors
wrote. They also found that, the newer
the clot, the better the probe binds to
fibrin, which could help physicians decide which clot to direct their attention
to first.
The test is expected to be studied in
humans in late 2015 or early 2016.
Source: Blasi F, Oliveira BL, Rietz TA, et al. Multisite thrombus
imaging and fibrin content estimation with a single whole-body
PET scan in rats. Arterioscler Thromb Vasc Biol. 2015 August 13.
[Epub ahead of print].
FDA Grants Ixazomib
Priority Review for
Treatment of Multiple Myeloma
The U.S. FDA granted priority review to
the oral proteasome inhibitor ixazomib, in
combination with lenalidomide and dexamethasone, for the treatment of patients
with relapsed/refractory multiple myeloma.
The decision was based on the results
of the phase III TOURMALINE-MM1
trial. In the study, 722 patients were
treated with 25 mg of lenalidomide
orally on days one through 21; 40 mg of
dexamethasone orally on days one, eight,
15, and 22; and either 4 mg of ixazomib
or placebo on days one, eight, and 15.
Patients enrolled in the study received
one to three prior therapies and had an
Eastern Cooperative Oncology Group
score of zero, one, or two. Patients who
were refractory to lenalidomide or a
proteasome inhibitor were excluded from
the study. The primary endpoint was
progression-free survival (PFS).
PFS was improved in patients receiving ixazomib with lenalidomide and
dexamethasone compared with those
receiving lenalidomide and dexamethasone alone. Though the study met its
primary endpoint, no additional data
were released on the trial’s findings.
Four other phase III studies are
expected in the TOURMALINE MM
clinical trial series, with MM2 focused on the combination of ixazomib,
lenalidomide, and dexamethasone in
newly diagnosed multiple myeloma
patients, and MM3 and MM4 studies
investigating the drug’s use for maintenance therapy in those who have and
have not undergone an autologous stem
cell transplantation.
The U.S. FDA is expected to make a
final decision on approval of ixazomib
in March 2016.
Ixazomib is also being evaluated in
combination with dexamethasone for
patients with relapsed/refractory systemic light-chain (AL) amyloidosis. In
December 2014, ixazomib was granted
breakthrough therapy designation for
patients with AL amyloidosis.
Source: U.S. FD