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ZIOPHARM Oncology: Ziopharm Announces Data Highlighting

The following excerpt is from the company's SEC filing.

Ad-RTS-hIL-12 Activity in Glioma at SNO

Early Clinical Results Find Veledimex Crosses Blood Brain Barrier,

Ad-RTS-hIL-12 Activation in Tumor Results in IL-12 in Peripheral Blood, Treatment

Is Well Tolerated with Minimal Neurologic Toxicity

BOSTON, MA November 19, 2015

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, today announced that the Company is presenting initial results from an ongoing Phase 1 dose-escalation study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastom a or grade III malignant glioma. The presentation, titled Intratumoral Regulated Expression of IL-12 as a Gene Therapy Approach to Treatment of Glioma, will be delivered at 5:15 pm CT, Saturday, November 21, 2015 at the 20th Annual Society for Neuro-Oncology (SNO) Annual Scientific Meeting in San Antonio, Texas. Ad-RTS-hIL-12 + the oral activator 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.

Immunotherapy is an attractive approach for the treatment of glioma, an aggressive cancer with few treatment options, said Nino Chiocca, MD, PhD, Harvey W. Cushing Professor of Neurosurgery, Department of Surgery, Harvard Medical School, Surgical Director, Center for Neuro-oncology, Dana-Farber Cancer Institute, Chairman, Neurosurgery, Brigham And Womens Hospital and Co-Director, Institute for the Neurosciences, Brigham And Womens Hospital. IL-12 is among the most potent anti-cancer immune cytokines, yet carries equally significant potential for immune-mediated toxicities. The ability to turn IL-12 expression on and off using an orally activated gene switch, particularly in the brains immune privileged environment, is a tremendous advancement in the potential of this therapeutic approach. We look forward to enrolling additional patients and follow up from this study to evaluate Ad-RTS-IL-12s potential in this challenging, rapidly advancing and lethal disease.

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...


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