Data From a New Study on Diagnocure's GCC Assay Show Positive
Results for Predicting Risk of Colon Cancer Recurrence
PrevistageTM GCC colorectal cancer test
featured at the 2013 ASCO Annual Meeting
QUEBEC CITY, June 3, 2013
/PRNewswire/ - DiagnoCure Inc. (TSX: CUR)
(OTCQX: DGCRF) today reported that results of a new study were
presented on Sunday, June 2, during
the 2013 American Society of
Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois. The
abstract of the presentation entitled "Guanylyl cyclase C (GCC)
expression in lymph nodes (LNs) as a determinant of recurrence in
stage
II colon cancer (CC) patients (pts)" (Abstract #3639), by Dr.
Daniel J.
Sargent, Professor of Biostatistics and Oncology at Mayo
Clinic, and
colleagues, is now available on the American Society of
Clinical
Oncology's website, www.asco.org.
"We believe this new study provides very strong evidence that
measuring
the expression level of GCC in lymph nodes is central to
improved
staging for patients diagnosed with node-negative colon cancer."
said
Dr Yves Fradet, President and Chief
Medical Officer of DiagnoCure.
"Prognostic risk stratification in stage II colon cancer remains a
very
clinically important issue and the ability of our
PrevistageTM GCC test to predict recurrence
independently of traditional
histopathology risk factors should have significant clinical impact
for
physicians treating colon cancer and their patients."
The VITAR retrospective study (Validating Indicators To
Associate
Recurrence) had been designed to assess the relationship between
GCC
gene expression in formalin fixed (FFPE) LNs and time to
recurrence
(TTR) in stage II Colon Cancer patients not treated with
adjuvant
chemotherapy. The second phase (called VITAR II), the results of
which
were presented at the 2013 ASCO meeting, focused on the positive
lymph
node ratio (LNR), defined as the number of nodes in which cancer
cells
were identified with the GCC assay, divided by the total number
of
nodes examined to provide recurrence risk stratification. On a
validation set including 463 untreated stage II (T3N0) colon
cancer
patients from North American and European sites, the study showed
that
molecular staging based on GCC LNR status was able to predict
higher
recurrence risk for 195 patients (42%) treated by surgery alone.
All
patients had not been treated with adjuvant chemotherapy mainly
because
their lymph nodes appeared cancer-free by examination under the
microscope, yet 10% of them had a disease recurrence or died
from
cancer afterwards.
Outcome associations were also strengthened when considering a
3-level
GCC categorization. In the final study cohort (n=366), the
PrevistageTM GCC test classified 21.8% of patients as
having a high risk of
recurrence following surgery, 17.5% at intermediate risk and 60.7%
of
patients at low risk of recurrence. In this subset analysis, the
5-year
recurrence risk was estimated at 8% and 22% for the low and high
risk
groups respectively, with a hazard ratio of 2.7 (p=0.006)
supporting
the prognostic capabilities of the GCC nodal status as an
independent
risk factor.
These findings complement those obtained during the first phase of
the
prospectively specified multi-center VITAR study performed on 241
stage
II CC patients which were published in 2011 (Sargent, Annals Surg
Onc
2011).
About Colorectal Cancer and PrevistageTM GCC
Every year in the United States
and Canada, 165,000 people are
diagnosed
with colorectal cancer. Of that number, 69,000 are considered at
low
risk after surgery. Nonetheless, up to 20% of them suffer
recurrence of
a more advanced cancer. To date, results of published studies
totaling
over 1,000 patients have shown that, compared with
traditionally-used
factors, the GCC biomarker is a better predictor of disease
recurrence
in early?stage colorectal cancer patients. PrevistageTM
GCC is currently the only colorectal cancer staging test that
provides
prognostic information based on the tumor burden measured at
the
molecular level in the lymph nodes. Tumor burden in the lymph nodes
has
become more widely recognized by treating physicians as a key
prognostic factor to determine the risk of recurrence of cancer
patients, and hence, to determine which patients might benefit
most
from adjuvant chemotherapy and which could be safely managed
without
chemotherapy.
About DiagnoCure
DiagnoCure (TSX: CUR; OTCQX: DGCRF) is a life sciences corporation
that
develops and commercializes high-value cancer diagnostic tests
that
increase clinician and patient confidence in making critical
treatment
decisions. In 2008, the Corporation launched a colorectal
cancer
staging test through its U.S. CLIA laboratory. PrevistageTM GCC
is
currently available for licensing. The Corporation has granted
a
worldwide exclusive license to Gen-Probe, now a wholly-owned
subsidiary
of Hologic Inc. operating as Hologic Gen-Probe, for the development
and
commercialization of a prostate cancer test using PCA3,
DiagnoCure's
proprietary molecular biomarker. Hologic Gen-Probe's PROGENSA®
PCA3
test is commercialized in Europe
under CE mark and is approved for
commercialization in Canada and
the United States. For more
information, please visit www.diagnocure.com.
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SOURCE DiagnoCure inc.