The company reported on a Phase 2 clinical trial of VAL-083 in recurrent MGMT-unmethylated glioblastoma (GBM), which is being conducted in collaboration with The University of Texas MD Anderson Cancer Center, designed to enroll up to 48 patients to determine if VAL-083 treatment improves overall survival compared to historical reference control.
DelMar reported that 27 subjects have been screened and 15 have been enrolled since the opening of recruitment in February 2017. All patients enrolled in the study have recurrent MGMT-unmethylated GBM with radiographic evidence of progression and were not surgically resected at the time of enrollment.
The company reported that 96% of patients enrolled were alive at the time of the analysis and 40% of patients enrolled were reported to have achieved stable disease as assessed by MRI following treatment with VAL-083 as a single agent.
The company also provided an overview of the design of a separate Phase 2 clinical trial of VAL-083 for newly diagnosed MGMT-unmethylated GBM patients. In this trial, which was recently initiated at Sun Yat-Sen University Cancer Center, patients will be treated with VAL-083 plus radiotherapy as an alternative to standard-of-care temozolomide plus radiation in the front-line setting.
The trial is designed to enroll up to 30 patients with MGMT-unmethylated GBM to determine if VAL-083 treatment improves progression free survival compared to a historical reference control.
VAL-083 induces potent anti-cancer activity against treatment-resistant cells from glioblastoma, lung, prostate and ovarian tumors. Cancer cells treated with VAL-083 exhibit persistent DNA double-strand breaks and activation of the homologous DNA repair system. Activation of the HR system is an indicator of VAL-083's unique anti-tumor activity.
DelMar Pharmaceuticals is developing cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The company is headquartered in Vancouver, British Columbia, and has research & clinical operations in Menlo Park, California.
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