Rare Disease Report

Phase 2 Glioblastoma Multiforme Trial Underway

FEBRUARY 12, 2017
Andrew Black
DelMar Pharmaceuticals has begun dosing patients in their Phase 2 clinical trial of VAL-083 (dianhydrogalactitol) for the treatment of MGMT-unmethylated recurrent Glioblastoma Multiforme (GBM).
The study is a Phase 2 single arm clinical trial assessing dianhydrogalactitol in patients 18-years and older diagnosed with MGMT unmethylated, Bevacizumab-naive recurrent GBM. Patients will receive 40 mg/m2 of dianhydrogalactitol through IV for 30-60 minutes on days 1, 2, and 3 of a 21-day treatment-cycle, for up to 12, 21-day treatment cycles.
VAL-083 (dianhydrogalactitol) is a small-molecule chemotherapeutic. The drug is deisnged to cross the blood-brain barrier and accumulate in brain tumor tissue. Dianhydrogalactitol’s mechanism of action is bifunctional DNA alkylation at the N7 position of guanine.
The clinical trial is currently enrolling patients, to learn more visit https://clinicaltrials.gov/ct2/show/NCT02717962

About Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is a rare but very aggressive form of brain cancer. Glioblastomas can be classified as primary or secondary. Primary glioblastoma tends to occur in older adults (> 50 years) and appear quite suddenly (less than 3 months from initial symptoms to diagnosis). Secondary glioblastoma is less common and occurs in younger patients (< 45 y). These tumors can be present for years before symptoms appear.
Standard therapy for glioblastoma consists of surgical resection, radiation therapy, and chemotherapy. Patients treated with this standard therapy tend to survive for approximately 12 months. Without treatment, survival is about 3 months.

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