Ad-IL-12: Phase I/II data

Ziopharm reported data from 13 patients in the dose-escalation Phase I portion of an open-label, U.S. Phase I/II trial showing that 5 of 7 patients receiving intratumoral injections of Ad-RTS-IL-12 plus the 2 highest doses of an oral activator ligand (INXN-1001) had signs of "clinical activity." No dose-limiting toxicities (DLTs) were reported, but there were 3 serious adverse events - pyrexia and cytopenia, which were related to treatment, and deep vein thrombosis (DVT) unrelated to treatment. There was 1 patient death unrelated to therapy reported due to bacterial sepsis and disease progression. Ziopharm also said the first patient has been dosed in the open-label Phase II portion of the trial, which will enroll up to 15 patients with unresectable stage III or IV melanoma. Data are expected in 1H13. ...