Exiqon A/S
Redefining high risk patients with stage II colon cancer

Exiqon A/S 

12.09.2014 10:19

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Exiqon A/S (NASDAQ OMX Copenhagen: 'EXQ') today announced the publication of
data from a population based study of 554 patients with stage II colon cancer,
using the company's proprietary miRCURY LNA(TM) Universal RT microRNA PCR platform
to validate the prognostic value of microRNA-21 based on tissue sections from
formalin fixed paraffin embedded tumour blocks (FFPE samples). End-points were
overall survival (OS) and recurrence free cancer specific survival (RF-CSS). 

The study results support microRNA-21 as an independent prognostic biomarker
for recurrence free cancer specific survival in a population based cohort of
patients with stage II colon cancer, which received surgical intervention.
Assessment of microRNA-21 levels wasbased on qPCR analysis of microRNA-21 in
standard FFPE samples, and high microRNA-21 expression was associated with an
unfavourable RF-CSS. The cross-validated area under the curve (AUC) for 1- and
5-year RF-CSS were 0.67 and 0.68, respectively. The results appeared in British
Journal of Cancer 

This study confirms results from a previous study published in British Journal
of Cancer in 2012, of the same cohort of patients using the company's
proprietary LNA(TM) based in situ hybridization to analyze microRNA-21 levels. The
earlier study showed that patients expressing high levels of miR-21 had
significantly inferior recurrence-free cancer-specific survival, suggesting
that analyses of microRNA-21 should be considered as a potential adjunct in the
selection of high risk stage II colon cancer patients. 

The new study tested the prognostic value of a qPCR based assessments of
microRNA-21 levels in standard FFPE stage II tumour samples in combination with
a traditional panel of prognostic biomarkers to create an individual risk index
in patients with stage II colon cancer. Individual biomarkers might not be
powerful enough to identify clinically relevant risk groups in a cohort of
patients where the majority has already been cured by the surgical intervention
and has relatively good prognosis. Hence, the aim of the index approach was to
strengthen existing markers by combining these traditional biomarkers with the
molecular based biomarker microRNA-21 to provide for a clinically more robust
stratification. 

The study result suggests that introducing a risk index includingmicroRNA-21
for stratifying patients with stage II colon cancer may lead to the
identification of a considerably smaller group of high risk patients (23% of
the patients at high risk) than the traditional risk parameters (77% of the
patients), holding promise to spare a large fraction of patients from needless
and harmful adjuvant chemotherapy. The proposed risk index classifies patients
correctly (high or low risk) with a probability of approximately 70%. The
cross-validated AUC for the recurrence free cancer specific survival (RF-CSS)
index at 1- and 5-year was 0.714 and 0.667, respectively. 

The identification of high risk patients is a first step in a possible
stratification of patients for adjuvant therapy. The current study does not
address whether high risk patients with elevated microRNA-21 expression also
will benefit from adjuvant therapy. The possible predictive value of
microRNA-21 in identifying high-risk patients who will respond to adjuvant
chemotherapy  will require further clarification in a clinical context. 

With the publication of the current microRNA-21 study, it is clear that
microRNA-21 possesses independent prognostic value which in combination with
more traditional biomarkers can improve identification of high risk patients.
This is a step forward towards better treatment decisions of stage II colon
cancer patients who may benefit from being identified as eligible to
chemotherapy. Exiqon will proceed with launch of the microRNA-21 test as a RUO
(Research Use Only) kit to facilitate further testing and eventually clinical
incorporation of microRNA-21 along with other biomarkers to create colorectal
cancer recurrence tests,. The launch is planned for later this year. 

Additional information
Lars Kongsbak, President and CEO, tel. +45 4566 0888 (cell: +45 4090 2101)
News Source: NASDAQ OMX



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Language:     English
Company:      Exiqon A/S
              
               
              Denmark
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         DK0060077758
WKN:          
 
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