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DelMar Pharmaceuticals initiates Phase 2 clinical trial in newly diagnosed MGMT-unmethylated GBM

Published 09/11/2017, 08:06 AM
DelMar Pharmaceuticals initiates Phase 2 clinical trial in newly diagnosed MGMT-unmethylated GBM
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  • DelMar Pharmaceuticals (NASDAQ:DMPI) initiates a Phase 2 clinical trial for its lead agent VAL-083 in newly diagnosed MGMT-unmethylated glioblastoma multiforme (GBM). The biomarker-driven clinical trial will explore safety and efficacy of chemoradiation with VAL-083 as an alternative to standard-of-care temozolomide.
  • The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of a DNA-repair enzyme and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population.
  • The primary efficacy endpoint of this trial is progression free survival (PFS). It is expected that safety/tolerability and primary efficacy PFS data will become available within 9 and 15 months, respectively from start of enrollment. Results will be used to guide the design of global randomized studies, which if successful, will position VAL-083 as a potential replacement for the current standard-of-care in newly diagnosed GBM patients.
  • VAL-083 (dianhydrogalactitol), an orphan drug designation is a DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death.
  • Now read: Patients, The Center Of Our Efforts

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