DAG for Injection: Additional Phase I/II data

Additional data from an open-label, U.S. Phase I/II trial in 30 patients with refractory GBM showed that IV VAL-083 given on days 1-3 of a 21-day cycle led to a median progression-free survival (PFS) of 1.2-1.4 months. Median overall survival (OS) was 9 months at doses of >=30 mg/m 2 VAL-083 vs. 4.4 months at doses of <10 mg/m 2 VAL-083. VAL-083 led to 6- and 12-month OS rates of 41.4% and 17.2%, respectively. There were 2 dose-limiting toxicities (DLTs) at the 50 mg/m 2 dose of VAL-083, which DelMar said is above the MTD. The trial is enrolling GBM patients previously treated with surgery and/or radiation if appropriate and who failed both Avastin bevacizumab and temozolomide unless contraindicated. The trial now is enrolling up to 14 patients in an expansion cohort evaluating a 40 mg/m 2 dose of VAL-083, as well as a 3-patient cohort at a 45 mg/m 2 dose. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...