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ProGEM™ - Biomarker Diagnostic for Targeted Therapy
Analyses of several of academic-led clinical studies of
COX-2 inhibitors in the treatment of cancer demonstrated that
patients with active COX-2 systems in their tumors (defined
as either (i) increased COX-2 expression in tumors measured
using IHC, or (ii) patients who, in response to treatment
with a COX-2 inhibitor, had major decreases in their urinary
metabolite of PGE2 known as PGEM) had longer survival versus
patients without active COX-2 systems. Tragara is utilizing
the measurement of the urinary metabolite PGEM as the basis
for patient selection in its personalized medicine strategy
for the clinical development of Capoxigem. The measurement
of urinary PGEM provides for ease of sample acquisition and
for real-time analysis of the COX-2 dependence of the tumor.
Urine samples can be tested for PGEM levels utilizing a liquid
chromatography-mass spectrometry (LC-MS) method.
To support the use of PGEM as a biomarker for the selection
of patients for treatment with Capoxigem, Tragara is developing
a PGEM immunoassay. The aim of the ProGEM program is a simple-to-use
urinary diagnostic kit for standardized PGEM measurement in
any CLIA-certified laboratory.
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