DelMar Announces Accelerated Patient Enrollment of Trial in MGMT-unmethylated Recurrent GBM

DelMar updated patient enrollment data for its Phase 2 open-label clinical trial of VAL-083 in bevacizumab (Avastin)-naïve recurrent glioblastoma multiforme (rGBM) patients with MGMT-unmethylated status.

This trial is being conducted at MD Anderson Cancer Center and as of June 15, 2018, has enrolled 33 of the planned 48 patients. The trial is designed to determine the impact of VAL-083 treatment on overall survival compared to historical reference control.

"We are pleased with the accelerated patient enrollment of our ongoing VAL-083 Phase 2 trial at MD Anderson Cancer Center. Presently, the trial is approximately six months ahead of schedule and based on the trial's protocol design, we anticipate the primary endpoint of median overall survival to be reached approximately three months after the final patient is enrolled," said Saiid Zarrabian, President and Chief Executive Officer of DelMar.

VAL-083 (dianhydrogalactitol) is a "first-in-class," DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083's anti-tumor activity is unaffected by common mechanisms of chemoresistance in vitro.

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 has been granted fast-track status for the treatment of recurrent GBM by the US FDA.