MDxHealth’s MGMT Methylation Test Selected for Phase III Brain Cancer Trial
German university hospital will use PredictMDX to select patients for lumostine study.!--h2>
MDxHealth inked an agreement with researchers at the University Hospital of Bonn for the firm’s epigenetic MGMT test PredictMDx™ for glioblastoma. The hospital will use the test to select patients for enrollment into a two-year Phase III study evaluating the addition of lomustine to therapy with temozolomide and radiotherapy in MGMT-methylated, newly diagnostic patients with glioblastoma multiforme (GBM). The CeTeG trial is due to start recruiting patients this month.
PredictMDx for glioblastoma is MDxHealth’s most advanced epigenetic assay, and is designed to test for methylation of the MGMT gene to help identify newly diagnosed GBM patients who are most likely to benefit from treatment with alkylating agents. The agreement with the University Hospital of Bonn comes less than a week after the firm inked a deal with Celldex, for use of the MGMT test in a Phase III study evaluating the latter’s immunotherapeutic vaccine Rindopepimut in brain cancer patients.
MDxHealth is developing and commercializing a pipeline of prognostic, predictive, and pharmacodiagnostic products for multiple cancer types, including prostate, brain, colon, and lung. For each cancer type the company is planning to generate and offer combinations of different assays: ConfirmMDx products will serve as an aid for physicians to assess the presence or absence of cancer; InformMDx tests will provide prognostic assessment to distinguish between aggressive and nonaggressive tumors; and PredictMDx assays are being developed to help predict which form of therapy will most likely suit individual patients.
The firm’s product development capabilities hinge on its MSP (Methylation-Specific-PCR) platform, a DNA-based technology that functions on standard commercial PCR equipment, and can assess the methylation status of virtually any group of CpG sites within a CpG island, independent of the use of methylation-sensitive restriction enzymes, the firm claims.