Assay will stratify patients on basis of MGMT gene methylation status for cilengitide trial.

Merck KGaA will employ MDxHealth’s methylguanine-DNA methyltransferase (MGMT) assay in a second clinical trial evaluating its glioblastoma candidate cilengitide. Merck is currently using the assay to select patients for the Phase III Centric trial, which is evaluating cilengitide in patients with newly diagnosed glioblastoma that harbors a methylated MGMT gene promoter. The new agreement will allow Merck to use the MGMT assay to stratify patients suitable for enrollment into the Phase II Core trial. In contrast to the Centric study, the Core trial will only include patients with an unmethylated MGMT gene promoter.  

MDxHealth is exploiting its methylation-specific-PCR technology platform to identify and validate biomarkers for a range of cancers. Predict MDxHealth for Brain, MDxHealth’s most advanced candidate, identifies MGMT methylation status in the tumor tissues of brain cancer patients to predict their response to alkylating agents. Essentially, if the MGMT gene is methylated, cancer patients tend to respond better to alkylating drug therapy.

Just three days ago, MDxHealth reported data from an international Phase III study in which PredictMDx for Brain successfully identified those glioblastoma patients who were likely to live longer and have a longer progression free survival following treatment with temozolomide. The Phase III RTOG 052 study was designed to compare standard adjuvant temozolomide therapy with a dose-dense schedule in 1,153 newly diagnosed glioblastoma patients. Results from the study were presented at the recent ASCO meeting and showed that MGMT status and recursive partitioning analysis class were significant predictors of overall survival, while the treatment arm and radiation technique were not.

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