Ziopharm to present new data from Ad-RTS-hIL-12 plus veledimex trial at SNO

Ziopharm announced it will update data from its Phase 1 trial of Ad-RTS-hIL-12 plus veledimex, a gene therapy designed to control the expression of interleukin 12, or IL-12, a powerful cytokine that has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent glioblastoma, or rGBM, at the meeting for Society for Neuro-Oncology, or SNO. Ziopharm’s presentation at SNO will include updated survival data for a group of 15 patients who received Ad-RTS-hIL-12 during surgical resection and the 20mg dose of veledimex, as well as the group of patients who received stereotactic administration of Ad-RTS-hIL-12. Additionally, the company will present further analysis of the effect of dexamethasone, as data suggests that lower versus higher dose of steroids improves overall survival. Ziopharm’s Ad-RTS-hIL-12 plus veledimex construct is designed to express human interleukin 12, or hIL-12, under the control of an orally administered activator ligand, veledimex through a proprietary RheoSwitch therapeutic system gene switch. Data from this Phase 1 trial previously revealed a median overall survival, or mOS, of 12.7 months for patients treated with Ad-RTS-hIL-12 plus 20mg of veledimex at a mean follow-up time of 12.9 months as of May 4. The mOS of 12.7 months compares favorably to the five to eight months survival established in historical controls for patients with rGBM. At SNO 2017, biopsy data from this study showed consistent, dose-dependent production of recombinant IL-12 leading to production of interferon gamma, an influx of CD3+ CD8+ cytotoxic T cells, and upregulation of PD-1 and PD-L1. The evaluation of Ad-RTS-hIL-12 plus veledimex as a monotherapy to treat patients with rGBM continues as the company is expanding the number of adult patients treated with 20mg of veledimex from 15 patients to up to 40, and a trial evaluating this treatment for pediatric patients with brain cancer is ongoing. Ziopharm also is conducting a Phase 1 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Opdivo, an immune checkpoint, or PD-1, inhibitor, in adult patients with rGBM.
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