Date: 2017-02-13
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: DelMar Pharmaceuticals (USA - CA)
Product: VAL-083 - 1,2:5,6-dianhydrogalactitol
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
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this phase 2, single arm, biomarker-driven study is to determine if treatment of O-6-methylguanine DNA methyltransferase (MGMT) unmethylated recurrent glioblastoma with VAL-083 improves overall survival (OS), compared to historical control. ( NCT02717962)
Latest
news: * On February 13, 2017, DelMar Pharmaceuticals announced that patient dosing has commenced in a Phase 2 clinical study of VAL-083 (dianhydrogalactitol) for MGMT-unmethylated Avastin® (bevacizumab)-naïve recurrent glioblastoma. The first patient was dosed by DelMar's collaborators at the University of Texas MD Anderson Cancer Center in Houston Texas. The Phase 2 trial will test safety, tolerability and clinical efficacy of VAL-083 in 48 adult subjects with MGMT-unmethylated glioblastoma whose tumors have recurred following surgery and standard chemo-radiation with temozolomide. Patients will receive 40 mg/m2 VAL-083 (IV) on days 1, 2, and 3 of a 21-day treatment-cycle, for up to twelve 21-day treatment cycles to determine if treatment with VAL-083 improves overall survival compared to historical controls. 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 glioblastoma and into a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated glioblastoma.
