ZIOPHARM Oncology Inc. reported positive updated results from its phase 1 study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma.
The results were from 25 patients with recurrent or progressive grade III or IV glioma enrolled in three veledimex dosing cohorts of 20 milligrams, 30 mg and 40 mg.
As of May 24, median overall survival of all patients receiving intratumoral Ad-RTS-hIL-12 with 20 mg of orally administered veledimex was maintained at 12.5 months, continuing to compare favorably to historical controls. Mean follow-up time was 9.2 months. The majority of patients in the 20 mg cohort had two or more recurrences prior to joining the study.
The company said survival appears correlated with IL-12-mediated cellular immune activation, and that steroid use in the first 15 days after injection of the virus appears to have a deleterious effect on patient survival.