Date: 2017-04-25
Type of information: Collaboration agreement
Compound: VAL-083 (dianhydrogalactitol)
Company: DelMar Pharmaceuticals (USA - CA) Duke University (USA - NC)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration - R&D -research
Action mechanism: alkylating agent. VAL-083 (dianhydrogalactitol) is a bi-functional alkylating agent causing N7-guanine alkylation and inter-strand DNA crosslinks. VAL-083's cytotoxic activity is independent of MGMT-expression in various cancer cells and cancer stem cells, suggesting a mechanism that is distinct from that of other alkylating agents. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas. VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.
Disease: glioblastoma multiforme
Details: • On April 25, 2017, DelMar Pharmaceuticals announced that it has entered into a three-year collaboration with Duke University to evaluate VAL-083, as a front-line treatment for newly diagnosed patients with glioblastoma multiforme. Under the terms of the collaboration, DelMar will fund a series of pre-clinical studies to be conducted by Duke University's Glioblastoma Drug Discovery Group to evaluate VAL-083, either alone or in combination with other agents, for activity against a range of glioblastoma subtypes (personalized drug development). The goal of the research will be to identify molecular characteristics of GBM tumors that are more likely to respond to VAL-083, and not the standard of care, temozolomide, as a front-line treatment or through combination therapies. DelMar is currently conducting a Phase 2 clinical trial in patients with MGMT-unmethylated, Bevacizumab-naive, recurrent GBM in collaboration with the University of Texas MD Anderson Cancer Center. DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase 3 clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM patients.
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