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DelMar Close to Completing Phase II Enrollment for Adjuvant VAL-083 in MGMT-Unmethylated GBM

NEW YORK – Biopharmaceutical company DelMar Pharmaceuticals said on Tuesday that it has enrolled 22 out of a planned 24 patients in an arm of an ongoing Phase II trial studying VAL-083 as a maintenance treatment in newly diagnosed, MGMT-unmethylated glioblastoma multiforme.

VAL-083, or dianhydrogalactitol, is a bifunctional DNA-targeting agent that can cause DNA double-stranded breaks, leading to cancer cell death. In prior clinical trials, VAL-083 has shown activity against a variety of cancers including GBM.

In an ongoing Phase II trial, DelMar is exploring the efficacy of VAL-083 in MGMT-unmethylated GBM patients in two arms. In one arm, the company aims to enroll up to 83 patients with recurrent or progressive GBM, where 35 patients would be treated at the 40 mg/m2 dose and up to 48 patients would receive the 30 mg/m2 dose. In this arm, 72 out of a planned 83 patients have been enrolled.

In the second arm, the company aimed to enroll another 24 newly diagnosed, MGMT-unmethylated GBM patients who have undergone surgery and chemoradiation treatment with temozolomide but received no subsequent maintenance temozolomide. In this study arm, the investigational VAL-083 will be given as maintenance therapy in place of standard of care temozolomide. The company has nearly met its enrollment goal in this arm with 22 patients.

The company said that it will continue to actively enroll patients in both trial arms even in light of the COVID-19 pandemic. The study is occurring at the MD Anderson Cancer Center.

DelMar is also conducting a Phase II study in China evaluating VAL-083 as a first-line treatment in 29 patients with newly diagnosed, MGMT-unmethylated GBM. The company will provide further updates on the development of VAL-083 at upcoming cancer conferences.