OncoMethylome Sciences Performs MGMT Testing in Cilengitide Studies for Glioblastoma
MKGAY | Quote | Chart | News | PowerRating -- OncoMethylome's Technology is being used in Merck KGaA's Clinical
Trial Program with Cilengitide
Liege (Belgium) - March 16, 2009, 09:00 AM CET - OncoMethylome
Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA)
announced today that it has begun MGMT gene promoter methylation
testing in a recently started Phase II clinical trial (CORE trial)
for cilengitide (Merck KGaA) in newly diagnosed brain tumors
(glioblastoma). In addition, testing is also being performed in a
Phase III clinical trial (CENTRIC trial) in newly diagnosed
glioblastoma that has been running since last year. For these trials,
OncoMethylome will provide MGMT gene promoter methylation testing
services. Patient selection for those trials is based on the MGMT
gene promoter methylation status of their tumor tissue.
Prior studies demonstrated activity of cilengitide in combination
with temozolomide and radiation therapy, the standard therapy for
newly diagnosed glioblastoma. The goal of the CENTRIC trial is to
demonstrate improvements in overall survival in patients with
methylated MGMT gene promoter being treated with the combination
therapy versus temozolomide/radiation therapy. Now in a companion
trial of CENTRIC, patients with unmethylated gene promoter also are
being enrolled in the phase II CORE trial in which they are treated
with an alternative cilengitide dosing schedule.
In a prior agreement with OncoMethylome, the German global
pharmaceutical and chemical group Merck KGaA received a worldwide,
non-exclusive license to use the results of the OncoMethylome MGMT
gene promoter methylation assay for optimizing glioblastoma
multiforme (GBM) treatment with cilengitide. OncoMethylome will
receive fees from Merck KGaA for performing the testing services.
Herman Spolders, CEO of OncoMethylome commented, "We are very pleased
that Merck KGaA has determined that testing for MGMT gene promoter
methylation is a very important component for selecting patients to
demonstrate effectiveness of cilengitide in this GBM patient
population. The CENTRIC and CORE trials represent another milestone
in our efforts to establish the clinical value of MGMT methylation
for aiding physicians in optimizing the treatment decision-making
process for patients with advanced brain tumors and confirms market
interest in our research and development of companion diagnostics."
To download this press release as a PDF, click here: Press Release
About GBM Brain Cancer
GBM is the most aggressive and malignant form of glioma, a type of
primary brain cancer. The annual incidence of GBM is four to five
cases per 100,000 persons, with 25,000 to 28,000 new cases diagnosed
each year in North America and Europe.
About OncoMethylome Sciences' MGMT Assay
The use of OncoMethylome's MGMT assay is based on studies that have
shown that methylation (silencing) of the MGMT gene promoter may help
to identify brain tumors more likely to respond to standard
chemotherapeutic agents. Following treatment, GBM patients whose
tumors are positive for MGMT gene promoter methylation have
demonstrated improved overall survival when compared to patients with
unmethylated or normally functioning MGMT. The MGMT assay was used in
a retrospective analysis of a subset of GBM patients in a study
published in The New England Journal of Medicine in March 2005 (N
Engl J Med 2005; 532; 997-1003). Prospective confirmation of the
predictive value of MGMT gene promoter methylation for the treatment
with radiotherapy and temozolomide is currently ongoing within a
large randomized international Phase III trial (Radiation Therapy
Oncology Group [RTOG] 0525-EORTC26052-22053).
About Cilengitide
Cilengitide is currently being developed by Merck KGaA. Cilengitide
is the first in a new class of investigational anti-cancer therapies
called integrin inhibitors to reach Phase III of development; it is
currently being investigated for the treatment of glioblastoma, SCCHN
and NSCLC. Integrin inhibitors are thought to work by targeting the
tumor and its vasculature.
Integrins are cell surface receptors that are improperly regulated in
many cancer types. This lack of regulation enables them to enhance
tumor growth, 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-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
KGaA for the development of cilengitide.
About OncoMethylome Sciences
OncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam:
ONCOA) is a molecular diagnostics company developing gene methylation
tests to assist physicians in effectively detecting and treating
cancer. Specifically, the company's tests are designed to help the
physician (i) accurately detect cancer in early stages of cancer
development, (ii) predict a patient's response to drug therapy, and
(iii) predict the likelihood of cancer recurrence.
OncoMethylome boasts a broad product development pipeline consisting
of over ten products and a solid partnering record. The company
collaborates with leading international molecular oncology research
centers, such as The Johns Hopkins University, and has a number of
commercial and collaborative partnerships with Veridex LLC, a Johnson
& Johnson company, LabCorp, Qiagen, Schering-Plough Corp.,
GlaxoSmithKline Biologicals, Abbott, Millipore Corporation's
BioScience Division, EXACT Sciences Corp., Merck KGaA and Qiagen.
OncoMethylome's products are based on methylation technology
invented by Johns Hopkins University (USA).
Established in January 2003, OncoMethylome has offices in Liege and
Leuven (Belgium), in Durham, NC (USA), and in Amsterdam (the
Netherlands).
For more information please contact:
Philip Devine
Tel. +32-479-801-902
ir@oncomethylome.com
www.oncomethylome.com
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
SOURCE: OncoMethylome Sciences
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