DelMar Pharmaceuticals' application for a Phase II study evaluating a treatment for newly diagnosed MGMT-unmethylated glioblastoma multiforme (GBM) has been accepted by the Human Genetic Resources Administration of China (HGRAC).
"Our clinical trials to date have been focused on recurrent GBM for patients whose tumors have recurred following currently approved therapies," DelMar Pharmaceuticals CEO Jeffrey Bacha said in a statement. "Obtaining HGRAC approval represents a significant step toward maximizing the potential benefit of VAL-083 in newly diagnosed GBM for patients whose tumors exhibit features, such as high expression of MGMT, which render them resistant to the current standard-of-care chemotherapy. Success of VAL-083 as a front-line treatment would be a major turning point for the brain tumor community and this area of science."
The company will begin enrollment for the trial in the next few weeks at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China. Professor Zhong-ping Chen, the chair of SYUCC’s Department of NeuroSurgery/Neuro-Oncology, will serve as the director.
“GBM has been largely left behind in the recent advancements made in the fight against cancer and new therapies improving median survival have been lacking,” Bacha said. “We strongly believe that VAL-083 represents a potential paradigm shift in the treatment of GBM, particularly for the two-thirds of newly diagnosed GBM patients whose tumors exhibit high expression of MGMT."