NEW YORK (GenomeWeb News) – MDxHealth today announced the extension of a deal with Merck KGaA for the use of its MGMT assay in Merck's brain cancer drug clinical trials.
Merck is currently engaged in a Phase III trial for its integrin inhibitor cilengitide for newly diagnosed patients with glioblastoma with a methylated promoter of the methylguanine-DNA methyltransferase, or MGMT, gene in the tumor tissue. MGMT gene promoter testing at MDxHealth's laboratories is required before patient enrollment in the trial called CENTRIC, the first prospective international controlled Phase III oncology trial that is using the MGMT assay as a standard for determining the patient population for a trial, MDxHealth said.
The new agreement continues a deal between MDxHealth and Merck that started with the CENTRIC trial in 2008. Merck also is conducting a randomized controlled Phase II study called CORE with cilengitide in newly diagnosed glioblastoma patients.
The CORE trial also is using the MGMT assay to stratify patients. However, participants in that trial require an unmethylated status of the MGMT promoter in the tumor, whereas patients in the CENTRIC trial require a positive methylation status of the MGMT gene promoter.
Financial and other terms of the alliance were not disclosed.