DAG for Injection: Additional Phase I/II data

Additional data from 30 patients in the first 7 cohorts of an open-label, dose-escalation, U.S. Phase I/II trial showed that doses of up to 40 mg/m 2 IV VAL-083 on days 1-3 of a 21-day cycle were well tolerated with no treatment-related serious adverse events or dose-limiting toxicities (DLTs) reported. Grade 1 lymphopenia and thrombocytopenia were reported at doses of >=20 mg/m 2. The MTD has not yet been reached. Three patients exhibiting stable disease or partial response reported improved clinical signs with a maximum response of 28 cycles prior to discontinuing treatment due to adverse events unrelated to treatment. An eighth cohort evaluating 50 mg/m 2 VAL-083 is ongoing. The trial is enrolling GBM patients previously treated with surgery and/or radiation if appropriate and who failed both Avastin bevacizumab and Temodar temozolomide unless contraindicated. Data were presented at the Society for NeuroOncology meeting in Miami. ...