MdxHealth (TM) : MDxHealth Epigenetic Marker as Companion Diagnostic for
Irinotecan based Therapy in Colorectal Cancer
Data Presented at ASCO
IRVINE, CA, and LIEGE, BELGIUM - 8:00 AM, June 3, 2013 - 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 2^nd 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
"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.
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).
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,
M€ 302.7 allocated budget until the end of 2015, 22 projects/consortia,
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.
For more information: Mike Sinclair Seth Lewis
Dr. Jan Groen, CEO Halsin Partners The Trout Group
MDxHealth UK: +44 20 7318 2955
US: +1 949 812 6979 Cell: +44 7968 022075 US: +1 646 378 2952
BE: +32 4 364 20 70 email@example.com firstname.lastname@example.org
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