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OncoMethylome Plans 2007 Launch for Brain Tumor PGx Test Following Schering-Plough Clinical Trial Milestone

OncoMethylome Sciences is on track to launch its first pharmacogenomics test — an assay to predict response to the brain tumor drug temozolomide — in 2007, company officials said last week.
In a conference call to discuss OncoMethylome’s financial results for the first half of 2006 — the company’s first earnings report since its €25 million ($32 million) IPO in late June — CEO Herman Spolders said that the firm is “on track” to launch three products in 2007: a test for the early diagnosis of prostate cancer; a colorectal cancer screening test; and the brain tumor pharmacogenomics test, which will assess the methylation status of the MGMT gene.
As proof of the company’s progress, Spolders cited a recent milestone payment from Schering-Plough, its development partner for the MGMT test. OncoMethylome and Schering-Plough entered a non-exclusive collaboration last November with the goal of evaluating the MGMT methylation test’s ability to predict response to Schering-Plough’s Temodar (temozolomide). 
In late August, OncoMethylome said that Schering-Plough had approved a subcontractor, BRT Laboratories, as a clinical trial testing facility, triggering the milestone payment. BRT will use OncoMethylome’s assay to test the methylation status of the MGMT gene in DNA extracted from brain tumor cells from more than 800 patients. The samples will come from a multi-center brain cancer clinical trial conducted by the Radiation Therapy Oncology Group in the US and the European Organization for Research and Treatment of Cancer and supported by Schering-Plough.
The trial is based on a study published in 2005 in the New England Journal of Medicine indicating that brain tumor patients with methylated MGMT were more likely to respond to temozolomide therapy than patients with unmethylated MGMT.
While OncoMethylome has not yet secured a commercial partner to fully develop a pharmacogenomics test based on the MGMT assay, Spolders said in the conference call that he is confident that the firm can find such a partner — and launch the test in a US-based service lab — in 2007.
In addition, Spolders said, several recent studies have show that MGMT methylation may be present in other cancers beyond brain cancer, and OncoMethylome is in discussions with Schering-Plough regarding an expansion of the current collaboration.
OncoMethylome is developing two other pharmacogenomics tests: one for lung cancer recurrence, which is still at the marker- and assay-development stage; and another for an undisclosed therapeutic area that is still at the marker-identification stage.  
Other Tests, Other Partners
In addition to pharmacogenomics R&D, OncoMethylome is developing a number of molecular diagnostics for cancer detection. Spolders said that the firm is on pace to launch two of these tests in 2007: one for prostate cancer in collaboration with Veridex, a Johnson & Johnson company; and one for colorectal cancer in collaboration with Exact Sciences.
J&J has exclusively licensed OncoMethylome’s test for the early diagnosis of prostate cancer, and has the option to license a prostate cancer screening test that the company is also developing. OncoMethylome expects a decision from J&J on whether to exercise the screening test option in the fourth quarter, but is confident that the company will decide in its favor. CFO Philip Devine said that OncoMethylome’s revenue projections of €2 million to €3 million for the full year of 2006 assume a milestone payment from J&J for the screening test in the fourth quarter.
As for the early-detection test, Spolders said that OncoMethylome has “completed all of its R&D obligations” and already collected a milestone payment from J&J. The company expects that test to be available through a US service lab in 2007.
In colorectal cancer, OncoMethylome is working with Exact Sciences to add methylation markers to Exact’s PreGen-Plus DNA-based stool test for the early detection of colorectal cancer. Spolders said that the company is also developing a methylation-only test for colorectal cancer.
OncoMethylome is about to begin two clinical trials for the modified PreGen-Plus test: a two-year population-based trial in the Netherlands and a Europe-wide multi-center trial that will collect blood and stool samples from colon cancer patients. Spolders said that the company expects to enter into a formal commercialization partnership with Exact Sciences in the first half of 2007 and to launch a colorectal cancer screening service through a service lab in the second half of the year.

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