DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" and "DelMar Pharma") today announced the presentation of interim data from a Phase 1/2 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.
"The fact that we are seeing evidence of clinical activity against refractory GBM at this stage is very promising," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "VAL-083 is safe and well-tolerated by patients at the doses tested to date, and based on historical data, we anticipate seeing stronger patient benefit and tumor responses as we achieve higher doses."
DelMar's Phase 1/2 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.