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.
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