On February 24, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported that, following the successful completion of the initial dose cohort, the first patient has been dosed at the succeeding dose level in the Company’s ongoing multicenter Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma or grade III malignant glioma (Press release, Ziopharm, FEB 24, 2016, View Source [SID:1234509172]). Ad-RTS-hIL-12 + veledimex is a novel viral gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T-cell immune response. Schedule your 30 min Free 1stOncology Demo! "This Phase 1 study of Ad-RTS-hIL-12 + veledimex is notable as it is among only a handful of multi-center gene therapy studies ever conducted, involves treatment directly in the brain tumor and addresses an advanced stage of disease where survival outcomes are often dire," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We are encouraged by the clinical observations to date and look forward to identifying the optimal dose as we continue to enroll additional patients in the trial."
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Dr. Lebel added: "Advanced brain cancer is a disease for which there are far too few treatment options. We look forward to presenting follow-up data from this study mid-year, and exploring additional therapy combinations in the clinic starting this year, including the addition of a checkpoint inhibitor to Ad-RTS-IL-12 + veledimex."
At the Society for Neuro-Oncology 20th Annual Scientific Meeting in November 2015, and in subsequent presentations, the Company announced results, including encouraging activity and "on-target toxicity," as well as evidence that veledimex crosses the blood brain barrier, from the first cohort in the study at a dosing regimen of Ad-RTS-hIL-12 2.0×10^11 + veledimex 20mg/day. After a review of tolerability data from this cohort of seven patients by a panel of independent neuro oncology experts, convened as the Data Safety Monitoring Board for the trial, the next dosing cohort of veledimex (40mg/day) was approved.
The ongoing multi-center Phase 1 trial of Ad-RTS-hIL-12 + veledimex examines a gene therapy strategy for recurrent high-grade gliomas, with the goal of generating a localized anti-tumor immune response. The primary objective of the study is to determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection activated upon dosing with oral veledimex. Secondary objectives are to determine the Ad-RTS-hIL-12 + veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 + veledimex, and assessment of biologic response. The Company anticipates reporting updated results from the study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016 and preclinical results combining Ad-RTS-hIL-12 + veledimex and checkpoint inhibitors at the American Society of Gene and Cell Therapy Annual Meeting in May 2016.