DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) today announced additional positive interim data from an ongoing Phase I/II clinical trial of VAL-083 in patients with recurrent glioblastoma multiforme (GBM) or progressive secondary brain tumor.
The data are being presented at the American Association for Cancer Research (AACR) Annual Meeting in Washington, D.C. during a clinical poster session entitled, "A Phase I/II Study of VAL-083 in Patients with Recurrent Malignant Glioma or Progressive Secondary Brain Tumor."
"These data represent continued progress to modernize the dosing regimen with VAL-083 as a potential treatment for recurrent brain tumors, including GBM, the most common and aggressive form of brain cancer. We are optimistic that we will continue to gather positive data as we reach higher doses in our clinical trial," said Jeffrey Bacha , President and Chief Executive Officer of DelMar Pharmaceuticals.
The data presented are part of an ongoing Phase I/II open-label, single arm dose-escalation study. Three dose cohorts were completed without reaching dose-limiting toxicity (DLT), and no drug-related adverse effects were detected. VAL-083 was seen to be safe and well tolerated at tested doses in patients who have failed other available therapies. In particular, GBM patients in the trial must have failed both bevacizumab (Avastin®) and temozolomide (Temodar®), unless either or both are contra-indicated.
Pharmacokinetic data reported by the Company demonstrated a dose response as expected based on observations reported in the historical literature. In addition, the Company previously presented data supporting the activity of VAL-083 against GBM tumors expressing resistance to the current front-line therapy, Temodar.
Mr. Bacha continued, "While these data are preliminary in nature, we have seen an overall response rate of 33.3%, where tumor growth had stabilized or regressed, in patients that had failed other therapies. We believe these data along with the differentiated mechanism of action of VAL-083, which supports potential activity when other therapies face tumor resistance, provides strong rationale for the further development of VAL-083."
Mr. Bacha further noted that doses of VAL-083 within the Company's proposed target doses had achieved reported response rates as high as 40 percent in historical GBM clinical trials sponsored by the U.S. National Cancer Institute (NCI).
"We look forward to continuing to work with our clinical investigators toward determining an optimal dosing regimen for future registration trials and to the potential opportunity of offering patients a valuable new treatment option for these aggressive brain cancers," added Mr. Bacha.
DelMar Pharmaceuticals, Inc.