NEW YORK (GenomeWeb News) – MDxHealth said today that Celldex Therapeutics will use its epigenetic MGMT test during recruitment of patients for a Phase III clinical study of Celldex's immunotherapeutic vaccine, rindopepimut, in newly diagnosed glioblastoma multiforme.
The study is expected to recruit 374 patients with newly diagnosed EGFRvIII-expressing GBM, an aggressive form of brain cancer, following gross total resection at more than 150 global clinical sites.
MDxHealth's MGMT test will be used to test patients expressing EGFRvIII to determine methylation status of the MGMT promoter gene. Results will be used to "ensure that the two arms of the clinical trial are balanced for the known prognostic influence of improved overall survival in MGMT methylated individuals," MDxHealth said in a statement.
Studies have demonstrated that epigenetic silencing of the MGMT gene promoter can be used to identify brain tumors likely to respond to standard chemotherapeutic agents. GBM patients whose tumors were positive for MGMT gene promoter methylation and who received treatment showed improved overall survival and better progression-free survival than patients with unmethylated or normally functioning MGMT, MDxHealth said.
Financial and other terms of the deal were not disclosed.