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OncoMethylome Sciences OncoMethylome's Technology to Be Used in Merck's Clinical Trial Program with Cilengitide
Liege (Belgium) - June 10, 2008, 08:00 CET - OncoMethylome Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA) announced today that it has signed a licensing and testing agreement with Merck KGaA of Darmstadt, Germany. Under the terms of the agreement, OncoMethylome will provide MGMT gene promoter methylation testing services for Merck's clinical trial program of cilengitide. As part of the agreement, Merck received a worldwide, non-exclusive license from OncoMethylome to use the results of the OncoMethylome MGMT gene promoter methylation assay for optimizing glioblastoma multiforme (GBM) treatment with cilengitide. Financial terms of the agreement are not disclosed.
Herman Spolders, CEO of OncoMethylome commented, "We are very pleased that Merck has determined that testing for MGMT gene promoter methylation is a very important component of this clinical trial program. This agreement represents another milestone in our efforts to establish the clinical value of methylation biomarkers for aiding physicians in optimizing the treatment decision-making process and confirms market interest in our companion diagnostic products."
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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 OncoMethlyome'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. It is an investigational integrin inhibitor that is designed to target the tumor and its vasculature. It is currently being investigated in the treatment of glioblastoma, prostate cancer and melanoma.
Integrins are cell surface receptors that are improperly regulated in many cancer types which enable 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 KGaA-initiated studies, the U.S. National Cancer Institute (NCI) is sponsoring a number of clinical trials with cilengitide under a Cooperative Research and Development Agreement (CRADA) with Merck KGaA. An initial Phase I/II study in adult high-grade glioma (including GBM) patients has been performed. Several NCI-sponsored studies with cilengitide in various tumor types, including newly diagnosed glioblastoma and recurrent glioblastoma are currently ongoing.
About Merck KGaA Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
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 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, Schering-Plough Corp., GlaxoSmithKline Biologicals, Abbott, Millipore Corporation's BioScience Division, and EXACT Sciences Corp. 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: Lucija Turcinov Tel. +32-479-801-902 ir@oncomethylome.com www.oncomethylome.com
