BioCentury
ARTICLE | Clinical News

DAG for Injection: Additional Phase I/II data

July 21, 2014 7:00 AM UTC

Data from 2 patients with refractory GBM in the 6th cohort of an open-label, U.S. Phase I/II trial showed that 30 mg/m 2 IV VAL-083 led to no treatment-related serious adverse events and produced 1 case of stable disease after 1 treatment cycle. The MTD has not yet been reached. A 7th cohort is evaluating a 40 mg/m 2 dose of VAL-083. DelMar said if the MTD is not reached in the 7th cohort, the company will be prepared to file a protocol amendment with FDA to allow dosing beyond 40 mg/m 2. 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 American Society of Clinical Oncology meeting in Chicago. ...