ZIOPHARM Provides Update on Phase 1 Study of Ad-RTS IL-12 in Advanced Melanoma
ZIOPHARM Oncology (NASDAQ: ZIOP) today announced that compelling clinical activity was seen in its Phase 1 study of Ad-RTS IL-12, a novel DNA-based therapeutic candidate, in advanced melanoma. Based on early activity, and determination of a biologically effective dose, the Company also announced that the study has advanced to Phase 2 in which the first patient has been dosed.
Initiation of the Phase 2 study follows the successful, dose-escalation Phase 1 study in which clinical activity was observed in 5 of 7 (71%) patients dosed at the two highest dose levels. The data also showed a correlation between T-cell immune responses and clinical outcome, with no dose-limiting toxicities reported. A total of 13 patients were enrolled in the Phase 1 study, and were treated with a range of doses of an orally administered activator ligand. Three serious adverse events (SAE) were reported: two related to therapy (pyrexia and cytopenia), and one unrelated (deep vein thrombosis). Unrelated to the study therapy, one patient death was reported due to bacterial sepsis and progression of disease. The Company expects to submit full results of the study