DAG for Injection: Phase I/II amended

DelMar submitted a protocol amendment to FDA to add 50 and 60 mg/m 2 doses of IV VAL-083 to an open-label, dose-escalation, U.S. Phase I/II trial in patients with recurrent malignant glioma or progressive secondary brain tumors. Under the current protocol, the maximum dose to be evaluated in the trial is 40 mg/m 2. The company said there have been no treatment-related serious adverse events or dose-limiting toxicities (DLTs) in the 40 mg/m 2 dose cohort (n=3) and that the MTD has not yet been reached.

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. DelMar plans to present detailed data from the trial at scientific meetings this half. ...