On July 9, 2015 DelMar Pharmaceuticals reported that the Company will be presenting updated clinical data on its lead product candidate, VAL-083, from its Phase I/II clinical trial in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer (Press release, DelMar Pharmaceuticals, JUL 9, 2015, View Source [SID:1234506194]).
DelMar’s abstract entitled, "Update on Phase 1/2 study of VAL-083 (dianhydrogalactitol) in patients with recurrent malignant glioma," will be presented during a poster session at GBM2015, II International Symposium on Clinical and Basic Investigation in Glioblastoma, being held September 9 – 12, 2015, in Toledo, Spain.
In spite of recent advances in cancer care, GBM continues to be the most common and malignant primary brain tumor in adults carrying a dismal prognosis with less than 15 months median survival. The symposium is designed with a focus on clinical and basic research in this devastating disease.
DelMar recently presented interim data from the trial at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.
DelMar’s multicenter Phase I/II clinical study with VAL-083 is ongoing in patients with recurrent GBM. Eligible GBM patients must have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.
DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). (ClinicalTrials.gov Identifier NCT01478178). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).