DelMar Updates Clinical Trial of VAL-083 for Adjuvant Treatment of Brain Tumors

DelMar Pharmaceuticals has enrolled 22 patients in the adjuvant arm of the Company's ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide -- or TMZ -- maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083.

The adjuvant arm of the Phase 2 study of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. Additionally, in the recurrent arm of the study, which is also being conducted at MDACC, 72 patients out of a planned 83 patients have now been enrolled. DelMar continues to actively enroll patients in both trial arms of the clinical study, even in light of the COVID-19 pandemic.

DelMar previously announced that it had completed full enrollment of the planned 29 patients in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. The trial is being conducted at the Sun Yat-sen University Cancer Center in Guangzhou, China, and is designed to determine whether first-line therapy with VAL-083 treatment improves progression free survival. The current standard of care is first line TMZ with radiation.

Pending meeting formats and other unforeseen changes, DelMar currently intends to announce additional clinical trial updates concomitant with planned scientific poster presentations at or around the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program May 29-31, 2020, and at or around the American Association for Cancer Research Virtual Annual Meeting II June 22-24, 2020.

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand 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, including MGMT, in cancer cell models and animal studies.

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