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DelMar Presents Interim GBM Results

Dose-escalation study shows safety

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

DelMar Pharmaceuticals has presented interim data from a Phase I/II clinical trial for VAL-083 in recurrent glioblastoma (GBM) at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) being held in conjunction with the 18th Annual Society for Neuro-Oncology (SNO) meeting in San Francisco.

Enrollment in the first four cohorts of the VAL-083 trial has been completed with no significant adverse events or dose limiting toxicity (DLT) observed. Twenty-five percent of patients evaluated in Cohorts 1-3 exhibited stable disease or tumor-regression and improved disease symptoms. Evaluation and clinical observations of Cohort 4 is ongoing.

DelMar’s Phase I/II study is an open-label, single arm dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with recurrent GBM. Patients in the trial must have been previously treated for GBM with surgery and/or radiation and must have failed both Avastin and Temodar, unless either or both are contra-indicated. Enrollment of Cohort 5 is expected in December 2013, following the mandated safety observation period with Cohort 4.

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