On December 10, 2015 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported the presentation of the study design and a trial update for a Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer (Press release, Ziopharm, DEC 10, 2015, View Source [SID:1234508528]). The poster presentation, titled "Phase 1b/2 study of intratumoral Ad-RTS-hIL-12 + veledimex in patients with chemotherapy-responsive locally advanced or metastatic breast cancer," was presented as part of the "Ongoing Trials – Immunotherapy" session of the 2015 San Antonio Breast Cancer Symposium, and is available online at www.ziopharm.com.
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The study, which is being conducted at the Memorial Sloan Kettering Cancer Center in New York and began enrollment in June 2015, is designed to examine the safety, tolerability and efficacy of Ad-RTS-hIL-12 immunotherapy in up to 40 women with locally advanced or metastatic breast cancer of all subtypes. Ad-RTS-hIL-12 + veledimex is a novel gene therapy which controls local expression of IL-12 and may induce tumor stroma collapse and stimulation of an anti-cancer T cell immune response. The ability to regulate the production of IL-12 by modulating veledimex dosing is designed to improve its therapeutic index with standard of care.
Following entry into the trial, patients go on a chemotherapy holiday and enter an immunotherapy phase of treatment. A single cycle of Ad-RTS-hIL-12, along with the oral activator ligand veledimex, is given during the immunotherapy phase, with the goal of maintaining or improving pre-study response. Continuation of HER2-targeted antibody therapy is permitted during this immunotherapy phase for women with HER2+ disease. The study design allows for a review of the trial after every five subjects with HER2‑ and with HER2+ disease are treated. To date, five patients have been enrolled, including four with HER2- disease and one with HER2+ disease.
"Following standard of care treatment with an immunotherapy has the potential to deliver a one-two punch in breast cancer, particularly in a setting where IL-12, a potent immune cytokine, has demonstrated profound effects on the tumor environment," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We are pleased to see patient enrollment in this study accelerating and, beginning in 2016, look forward to understanding how the promise of this approach translates into outcomes."