MDxHealth Epigenetic Marker as Companion Diagnostic for Irinotecan Based Therapy in Colorectal Cancer

MDxHealth Epigenetic Marker as Companion Diagnostic for Irinotecan Based 
Therapy in Colorectal Cancer 
Data Presented at ASCO 
IRVINE, CA and LIEGE, BELGIUM -- (Marketwired) -- 06/03/13 -- 
MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic
company that develops and commercializes epigenetic tests to support
cancer treatment, today announced data showing that methylation of
the Decoy Receptor 1 (DCR1) gene may help guide oncologists in
selecting metastatic colorectal cancer (CRC) patients to receive
irinotecanbased therapy. The data, presented on June 2nd at the 49th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, USA, showed that CRC patients with methylated DCR1 did not
benefit from the addition of irinotecan to capecitabine therapy.  
Identification of DCR1 as a novel hypermethylated gene associated
with a lack of benefit in adding irinotecan to capecitabine when
treating metastatic colorectal cancer was performed in the pathology
department of Prof. Gerrit Meijer (VUmc, Amsterdam) as part of the
CTMM public-private partnership DeCoDe (Decrease Colorectal Cancer
Death) project. Commenting on the discovery, Prof. Gerrit Meijer said
"As part of a concerted effort to reduce the enormous impact of
colorectal cancer on patients and healthcare systems, all 14 partners
in the DeCoDe project have worked tirelessly to identify novel
biomarkers that will aid in the diagnosis and treatment of the
disease."  
Prof. Wim Van Criekinge, CSO at MDxHealth added, "Predictive
molecular biomarkers can help guide the selection of patients that
are likely to respond to a given treatment, or in the case of DCR1,
identify patients who are unlikely to respond to specific therapy,
potentially sparing unnecessary toxicity and allowing treatment with
more effective, alternative therapies earlier."  
"The innovative use of advanced bioinformatics, combined with several
Next Generation molecular profiling methods, and integrated with
pharmacological data is one the key missions of NXTGNT and enables
the highly efficient identification of specific predictive
biomarkers, such as DCR1," stated Prof. Dieter Deforce, Head of the
Laboratory of Pharmaceutical Biotechnology at NXTGNT Center in
Pharmaco (Epi)genomics, a joint collaboration between MDxHealth and
the Ghent University. 
Study Details
 The presence of DNA methylation for a selected panel
of 22 genes was assessed on primary tumors of 185 patients with
metastatic CRC treated with firstline capecitabine (CAP, n=90) or a
combination of capecitabine and irinotecan (CAPIRI, n=95) in the
phase 3 CAIRO trial. Methylation status of each gene was correlated
to progression free survival (PFS) by treatment regimen. Genes for
which methylation status was associated with response to irinotecan
were validated in 166 patients treated with firstline CAP (n=78) or
CAPIRI (n=88). In CAPIRI treated patients, DCR1 methylation was
correlated to a shorter PFS compared to patients with unmethylated
DCR1 (hazard ratio [HR]=0.4, p = 0.0009). In patients with methylated
DCR1 PFS did not improve with CAPIRI treatment, compared to treatment
with CAP (discovery set: HR=0.8 p=0.4; validation set: HR=1.1, p=0.6,
in contrast to patients with unmethylated DCR1 (discovery set:
HR=2.5, p=0.00004; validation set: HR=1.7, p=0.004). 
About CTMM
 The CTMM (Center for Translational Molecular Medicine) is
a Netherlands-based public-private partnership. It is dedicated to
the development of technologies in molecular medicine that enable
early diagnosis and personalized treatment for main areas of disease
causing mortality and diminished quality of life in the western
world. Focus lies on oncology, cardiovascular, neurodegenerative and
infectious/auto-immune disease. CTMM operates by inviting, assessing,
and funding multidisciplinary projects that involve active
participation by Netherlands-based academia and industry. All CTMM
projects are judged by an independent International Advisory Board
and approved by a Supervisory Board based on their significant
potential to translate research knowledge into clinical practice. The
CTMM is funded by the Dutch government (50%), academia (25%) and
industry (25%). Additional funding is provided by supporting
foundations on behalf of patients.  
DeCoDe (Decrease Colorectal Cancer Death) is one of the CTMM
projects, with 14 partners and a project budget of 18.6 M Euro. Key
figures CTMM: 119 partners, MEUR 302.7 allocated budget until the end
of 2015, 22 projects/consortia, www.ctmm.nl. 
About MDxHealth(R) 
 MDxHealth is a molecular diagnostics company
that develops and commercializes advanced epigenetic tests for cancer
assessment and the personalized treatment of patients. The company's
first commercial product, ConfirmMDx(TM) for Prostate Cancer, has
been shown to help distinguish patients who have a true-negative
biopsy from those who may have undetected cancer. MDxHealth helps to
address a large and growing unmet medical need for better cancer
diagnosis and treatment information. The company has a proprietary
platform and a strong epigenetic product pipeline focused on the
development of products for prostate, brain, lung and colon cancers.
The company is based in Irvine, California with a European
headquarters in Liege, Belgium. For more information visit
MDxHealth's website at www.mdxhealth.com. 
This press release contains forward-looking statements and estimates
with respect to the anticipated future performance of MDxHealth and
the market in which it operates. Such statements and estimates are
based on assumptions and assessments of known and unknown risks,
uncertainties and other factors, which were deemed reasonable but may
not prove to be correct. Actual events are difficult to predict, may
depend upon factors that are beyond the company's control, and may
turn out to be materially different. MDxHealth expressly disclaims
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release to reflect any change in its expectations with regard thereto
or any change in events, conditions or circumstances on which any
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http://hugin.info/137314/R/1706712/565024.pdf  
For more information: 
Dr. Jan Groen
CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com  
Mike Sinclair
Halsin Partners
UK: +44 20 7318 2955
Cell: +44 7968 022075
msinclair@halsin.com  
Seth Lewis
The Trout Group 
US: +1 646 378 2952
slewis@troutgroup.com