Biopharmaceutical firm DelMar Pharmaceuticals has begun dosing in a Phase II clinical trial of VAL-083 for the treatment of MGMT-unmethylated Avastin (bevacizumab)-naïve recurrent glioblastoma multiforme (GBM).
VAL-083 is a small-molecule chemotherapeutic developed to counter the tumour activity in a range of cancers.
The Phase II trial will evaluate the safety, tolerability and clinical efficacy of the drug in 48 adult subjects with MGMT-unmethylated GBM whose tumours have recurred after surgery and standard chemo-radiation with temozolomide.
DelMar Pharmaceuticals chairman and chief executive officer Jeffrey Bacha said: "Our research demonstrates that VAL-083 is active independent of MGMT expression.
"This data, combined with data from prior clinical trials sponsored by the US National Cancer Institutes that establish VAL-083's activity against GBM, are the foundation of our belief that VAL-083 may provide a new therapeutic option for GBM patients whose tumours exhibit features making them resistant or unlikely to respond to currently available therapy."
GBM is a type of brain cancer with symptoms such as headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes.
The trial will assess the capability of the intravenously administered drug to improve overall survival for up to 12 21-day treatment cycles.
VAL-083 has obtained orphan designation from the US Food and Drug Administration (FDA) Office of Orphan Products to treat glioma, medulloblastoma and ovarian cancer, in addition to the orphan drug designation in Europe to treat malignant gliomas.
The firm intends to further evaluate VAL-083 in a randomised multi-centre Phase III clinical trial for the treatment of bevacizumab-failed GBM, as well as in a separate international Phase II trial for newly diagnosed MGMT-unmethylated GBM.
Image: Histopathological image of cerebral glioblastoma. Photo: courtesy of KGH/Wikipedia.