As part of the collaboration, MD Anderson will initiate a new Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression, prior to Avastin™ (bevacizumab) exposure. Patients eligible for the study will have recurrent GBM characterized by a high expression of MGMT, the DNA repair enzyme implicated in drug-resistance and poor patient outcomes following current front-line chemotherapy. MGMT promoter methylation status will be used as a validated biomarker for enrollment and tumors must exhibit an unmethylated MGMT promoter for patients to be eligible for the trial.
VAL-083 is a first-in-class small molecule chemotherapy that readily crosses the blood brain barrier. DelMar's research has demonstrated that VAL-083's anti-cancer mechanism is active independent of tumor MGMT status. Approximately 2/3 of GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with resistance to currently available chemotherapy and poor patient outcomes.
“The progress we continue to make with our research shows that VAL-083 may offer advantages over currently available chemotherapies in a number of tumor types,” said Jeffrey Bacha, chairman and chief executive officer, DelMar. “This collaboration will allow us to leverage world-class clinical and research expertise and a large patient population from MD Anderson as we extend and accelerate our clinical focus to include GBM patients following first recurrence of their disease.”
DelMar recently presented favorable interim data at the 2015 Society for Neuro-Oncology Annual Meeting from its ongoing Phase II clinical trial with VAL-083 as a potential “third-line” therapy in GBM patients whose tumors have recurred following treatment with both temozolomide and bevacizumab.