MDxHealth and Merck KGaA extend Agreement for use of MGMT Assay in Brain Cancer Clinical Trials

DURHAM, NC, and LIEGE, BELGIUM - June 9th, 2011 - MDxHealth SA (NYSE Euronext:
MDXH), a leading molecular diagnostics company in the field of personalized
medicine, announced today that it will extend its agreement with Merck KGaA,
Darmstadt, Germany, for use of MDxHealth's MGMT assay in Merck KGaA's brain
cancer clinical trials. Financial terms of the agreement are not disclosed.
 
Merck  KGaA's is currently investigating its integrin inhibitor cilengitide in a
Phase  III trial (CENTRIC) in newly  diagnosed patients with glioblastoma with a
methylated  promoter of  the methylguanine-DNA  methyltransferase (MGMT) gene in
the  tumor tissue. Glioblastoma is  the most aggressive and  most common form of
primary brain tumors.
 
Prior  to patient enrollment in CENTRIC, MGMT gene promoter testing performed at
the  laboratories of  MDxHealth is  required. CENTRIC  is the  first prospective
international  controlled Phase III oncology trial that uses the MGMT assay as a
standard to determine the patient population for a trial.
 
With  the new  agreement the  partners are  continuing their  collaboration that
started  with the pivotal Phase III  CENTRIC trial initiated in 2008. Merck KGaA
is  also conducting the  CORE trial, which  is a randomized  controlled Phase II
study  with  cilengitide  in  newly  diagnosed  glioblastoma patients. As in the
CENTRIC  trial,  the  CORE  trial  will  rely  on MDxHealth's MGMT gene promoter
methylation  assay for the  stratification of patients.  However, while patients
enrolled  in the CENTRIC trial require a positive methylation status of the MGMT
promoter in the tumor, patients in the CORE trial require an unmethylated status
of the MGMT gene promoter.
 
About cilengitide
Cilengitide  is currently being  developed by Merck  Serono, a division of Merck
KGaA.  Cilengitide is  the first  in a  new class of investigational anti-cancer
therapies  called  integrin  inhibitors  in  Phase  III  of  development;  it is
currently  being investigated for  the treatment of  glioblastoma, squamous cell
carcinoma of the head and neck and non-small cell lung cancer.
 
Integrins  are  cell  surface  receptors  that  are improperly regulated in many
cancer  types, leading to enhanced tumor  growth and survival, and invasiveness.
Integrins are fundamental in the process of angiogenesis (blood vessel growth) -
a  process that is essential for tumors as it enables them to grow past a finite
size.
 
In  addition to  the Merck  Serono-sponsored studies,  the U.S.  National Cancer
Institute  (NCI) is sponsoring  a number of  clinical trials under a Cooperative
Research and Development Agreement (CRADA) with Merck Serono for the development
of  cilengitide. In the United States and Canada, cilengitide is being developed
by EMD Serono, an affiliate of Merck KGaA.
 
About the MGMT assay: PredictMDx for Brain(TM)
PredictMDx  for Brain, MDxHealth's most  advanced personalized treatment product
is  a test  for predicting  patient response  to alkylating  agents, a  class of
chemotherapy  drugs. The test assesses the  methylation status of the MGMT gene,
which  is correlated with response  to drug therapy. The  MGMT gene is a crucial
DNA  repair gene. MDxHealth PredictMDx for  Bain test determines the methylation
status  of the MGMT gene in tumor tissue,  and can be used as a predictive assay
for  the treatment of brain cancer. MDxHealth PredictMDx for Brain test has been
shown  on thousands of patients to be  able to distinguish which cancer patients
are  likely to  respond to  the most  commonly used  class of brain cancer drugs
called  alkylating agents. This patented methylated  gene test is attractive for
new  brain cancer drug  developers since they  can more easily  target their new
drugs  to the patients who usually do  not respond to the traditional alkylating
agent drug regime.
 
About MDxHealth
MDxHealth   is  a  leading  molecular  diagnostics  company  that  develops  and
commercializes   oncology-based   molecular  diagnostic  testing  and  companion
diagnostics  for personalized medicine. The  company's numerous cancer tests are
based  on proprietary gene methylation technology and assist physicians with the
diagnosis of cancer, prognosis of recurrence risk, and prediction of response to
a  specific therapy. MDxHealth collaborates  with leading cancer research center
such as Johns Hopkins University, Duke University, Lovelace Respiratory Research
Institute,  Eastern Virginia  Medical School,  Cleveland Clinic,  Memorial Sloan
Kettering, and major European academic medical centers. The company has a number
of  commercial and collaborative partnerships with LabCorp, Merck & Co./Schering
Plough, GlaxoSmithKline Biologicals, Roche, Merck KGaA, Qiagen, Pfizer and other
industry leaders.
 
For more information:
Dr. Jan Groen, CEO                             Hans Herklots
MDxHealth                                        Capricorn One
+32 4 364 20 70                                   +41 79 598 7149
 
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disclaims  any obligation to update any  such forward-looking statements in this
release  to reflect any  change in its  expectations with regard  thereto or any
change  in events,  conditions or  circumstances on  which any such statement is
based unless required by law or regulation
 
2011-06-09 Merck ENG: 
http://hugin.info/137314/R/1521990/458173.pdf
 
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Source: MdxHealth via Thomson Reuters ONE
 
[HUG#1521990]