DelMar Pharmaceuticals has started patient enrolment and treatment in the adjuvant arm of a Phase II clinical trial evaluating VAL-083 for the treatment of MGMT-unmethylated glioblastoma multiforme (GBM).
The arm will recruit up to 24 newly-diagnosed patients who received surgery and chemoradiation with temozolomide (TMZ).
As part of DelMar’s trial, participants will be treated with VAL-083 instead of TMZ as adjuvant therapy.
VAL-083 is a bifunctional DNA-targeting molecule designed to deliver inter-strand DNA cross-links at the N7-position of guanine. This mechanism is said to cause DNA double-strand breaks and cancer cell death.
The newly-approved adjuvant arm is intended to offer early disease data on the investigational drug.
Meanwhile, the recurrent trial arm of the study is enrolling patients who were heavily pre-treated with TMZ before disease recurrence.
The recurrent arm has been approved to enrol up to 35 additional patients at a dose of 30mg/m². A total of 56 recurrent patients have been recruited to date.
DelMar Pharmaceuticals CEO Saiid Zarrabian said: “Enrolling and treating the first adjuvant patient in this study is an important milestone as it provides us with the opportunity to understand the best use for VAL-083 in the clinical setting, whether as first-line therapy along with radiation, as adjuvant therapy immediately following chemoradiation, or in the recurrent setting.
“We firmly believe in the potential for this compound and look forward to providing an opportunity for a larger patient population to benefit from VAL-083 treatment.”
The company is also studying VAL-083 in combination with radiotherapy as a first-line therapy for GBM in a Phase II trial in China.
VAL-083 has orphan drug designation for glioma, medulloblastoma, and ovarian cancer in the US, and to treat malignant gliomas in Europe.
The US Food and Drug Administration (FDA) also granted fast-track status for the drug candidate in recurrent GBM.