OncoMethylome Sciences to Perform MGMT Testing in Roche Phase III Study of Avastin for Glioblastoma

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Overig advies 06/01/2010 08:06
OncoMethylome's Technology is being used in Roche Clinical Trial Program with Avastin
Liege (Belgium) - January 6, 2010, 8:00 AM CET - OncoMethylome Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA) announced today that it has entered into an agreement with F. Hoffmann-La Roche Ltd., of Basel Switzerland, for MGMT gene promoter methylation testing in a Phase III clinical trial for the use of Avastin in newly diagnosed (glioblastoma [GBM]) brain tumors.

This trial will compare the current standard-of-care therapy, which is concurrent chemoradiation and adjuvant temozolomide "TMZ" (TemodarÃ’, Schering-Plough), with the standard-of-care plus bevacizumab (AvastinÃ’, Roche). All patients will be randomized to TMZ and radiotherapy or TMZ, radiotherapy and bevacizumab. OncoMethylome Sciences will receive payments for performing MGMT testing, using their patented Methylation-Specific PCR (MSP) technology, on all patients enrolled in this trial.

As evidenced by this trial, and numerous other Phase II and Phase III clinical trials of new therapies for advanced brain cancers, OncoMethylome's MGMT assay has become the method of choice for determining a patient's MGMT methylation status. In the future, such information may play a key role in selection of the optimal therapy for each patient. OncoMethylome's MGMT assay is also commercially available in North America through Laboratory Corporation of America (LabCorp) and in Europe through OncoMethylome.

Mr. Luc Segers, Senior Director Business Development at OncoMethylome commented, "We are very pleased that MGMT testing will be incorporated into this study, once again demonstrating the market interest in identifying biomarkers that will lead to more personalized healthcare."

About Glioblastoma Multiforme (GBM) Brain Tumors
GBM is the most aggressive and malignant form of glioma, a type of primary brain tumor. 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 (RTOG 0525-EORTC26052-22053).

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

About AvastinÃ’
Avastin is an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis - an essential process of development and maintenance of blood vessels which is required for a tumor to grow and to spread (metastasize) to other parts of the body.

Avastin's precise mode of action helps control tumor growth and metastases with only a limited impact on side effects of chemotherapy. Avastin has proven survival benefits across multiple tumor types. Avastin is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, lung cancer and kidney cancer. These types of cancer collectively cause nearly 3 million deaths each year. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and is now approved for the treatment of five tumor types: colorectal cancer, non-small cell lung cancer, breast cancer, brain (glioblastoma) and kidney (renal cell carcinoma).

Over half a million patients have been treated with Avastin so far. A comprehensive clinical program with more than 450 clinical trials is investigating the use of Avastin in various tumor types (including colorectal, breast, lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease).

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.

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 LabCorp, Schering-Plough Corp., GlaxoSmithKline Biologicals , Millipore Corporation's BioScience Division, 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 Europe and in Durham, NC (USA).






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