BOSTON, MA, USA I December 6, 2013 I ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced the unanimous approval of the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) for the initiation of a Phase 1 study of Ad-RTS-IL-12, an adenoviral vector engineered to express interleukin-12 under the control of veledimex, an oral activator, in subjects with recurrent or progressive glioblastoma or grade III malignant glioma (brain cancer). ZIOPHARM has announced plans to launch a Phase 1 study of Ad-RTS-IL-12 in malignant glioma in the first half of 2014. The Company is currently studying Ad-RTS-IL-12 in Phase 2 studies in melanoma and breast cancer.
“Malignant gliomas remain one of the deadliest forms of cancer. The stimulation of an immune response is a novel and intriguing therapeutic approach,” said E. Antonio Chiocca, M.D., Ph.D., Chairman, Department of Neurosurgery, and Co-Director of the Institute for the Neurosciences, Brigham and Women’s Hospital/ Dana Farber Cancer Institute, and Harvey Cushing Professor of Neurosurgery, Harvard Medical School. “Important variables to the efficacy and safety of such therapies include the immune-privileged status of the central nervous system, the processes that contribute to the suppression of immune responses and the ability to modulate a brain tumor specific immune response. In animal tumor models, Ad-RTS-IL-12 and veledimex demonstrate a significant ability to overcome these barriers by localizing and tightly controlling expression of the potent immune cytokine interleukin-12. I look forward to seeing this promising therapeutic approach move quickly into clinical trials in patients with malignant brain tumors.”
ZIOPHARM is developing Ad-RTS-IL-12 using Intrexon Corporation’s (NYSE:XON) RheoSwitch Therapeutic System® (RTS®) platform to control the expression of interleukin-12 and enable its safe and effective delivery as an anti-tumor agent. ZIOPHARM and Intrexon recently presented preclinical study results at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, supporting the capability of Ad-RTS-IL-12 in the treatment of glioma. These studies showed both the ability for veledimex to penetrate the blood brain barrier and a dose-related increase in survival in a mouse GL-261 glioma model. Animals treated with Ad-RTS-IL-12 survived throughout the duration of the study (100% survival at 75 days) with no significant adverse clinical signs observed. In contrast, the mean survival in the control groups was 22 (±3) days. These findings support localized regulated IL-12 production as an approach for the treatment of malignant glioma.
“The NIH Committee’s decision is an important step forward in bringing Ad-RTS-IL-12, a potentially transformative new DNA-based therapeutic, to the treatment of gliomas,” said Francois Lebel, M.D., Senior Vice President, Clinical Development and Medical Operations at ZIOPHARM. “In tumor models, Ad-RTS-IL-12 and veledimex demonstrate a unique ability to overcome these barriers by localizing and tightly controlling expression of the potent cytokine interleukin-12. Our preclinical data to date demonstrate both a precisely controlled biologic response using this gene expression system as well as a remarkable effect on these tumors, suggesting further evaluation in the clinic. We expect to initiate a multicenter Phase 1 study in the first half of next year, and look forward to understanding the clinical potential of this therapy in brain cancers.”
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression and control technology to deliver DNA for the treatment of cancer. ZIOPHARM’s technology platform employs Intrexon Corporation’s RheoSwitch Therapeutic System® platform to turn on and off, and precisely modulate, gene expression at the cancer site in order to improve the therapeutic index. This technology is currently being evaluated in Phase 2 clinical studies of the immune system cytokine interleukin-12 for the treatment of breast cancer and advanced melanoma. Multiple new Investigational New Drug applications for new targets using synthetic biology technology with monogenic and multigenic approaches are expected in 2014 and 2015. ZIOPHARM is also developing novel small molecules as potential cancer therapeutics.
SOURCE: ZIOPHARM Oncology
Post Views: 182
BOSTON, MA, USA I December 6, 2013 I ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced the unanimous approval of the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) for the initiation of a Phase 1 study of Ad-RTS-IL-12, an adenoviral vector engineered to express interleukin-12 under the control of veledimex, an oral activator, in subjects with recurrent or progressive glioblastoma or grade III malignant glioma (brain cancer). ZIOPHARM has announced plans to launch a Phase 1 study of Ad-RTS-IL-12 in malignant glioma in the first half of 2014. The Company is currently studying Ad-RTS-IL-12 in Phase 2 studies in melanoma and breast cancer.
“Malignant gliomas remain one of the deadliest forms of cancer. The stimulation of an immune response is a novel and intriguing therapeutic approach,” said E. Antonio Chiocca, M.D., Ph.D., Chairman, Department of Neurosurgery, and Co-Director of the Institute for the Neurosciences, Brigham and Women’s Hospital/ Dana Farber Cancer Institute, and Harvey Cushing Professor of Neurosurgery, Harvard Medical School. “Important variables to the efficacy and safety of such therapies include the immune-privileged status of the central nervous system, the processes that contribute to the suppression of immune responses and the ability to modulate a brain tumor specific immune response. In animal tumor models, Ad-RTS-IL-12 and veledimex demonstrate a significant ability to overcome these barriers by localizing and tightly controlling expression of the potent immune cytokine interleukin-12. I look forward to seeing this promising therapeutic approach move quickly into clinical trials in patients with malignant brain tumors.”
ZIOPHARM is developing Ad-RTS-IL-12 using Intrexon Corporation’s (NYSE:XON) RheoSwitch Therapeutic System® (RTS®) platform to control the expression of interleukin-12 and enable its safe and effective delivery as an anti-tumor agent. ZIOPHARM and Intrexon recently presented preclinical study results at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, supporting the capability of Ad-RTS-IL-12 in the treatment of glioma. These studies showed both the ability for veledimex to penetrate the blood brain barrier and a dose-related increase in survival in a mouse GL-261 glioma model. Animals treated with Ad-RTS-IL-12 survived throughout the duration of the study (100% survival at 75 days) with no significant adverse clinical signs observed. In contrast, the mean survival in the control groups was 22 (±3) days. These findings support localized regulated IL-12 production as an approach for the treatment of malignant glioma.
“The NIH Committee’s decision is an important step forward in bringing Ad-RTS-IL-12, a potentially transformative new DNA-based therapeutic, to the treatment of gliomas,” said Francois Lebel, M.D., Senior Vice President, Clinical Development and Medical Operations at ZIOPHARM. “In tumor models, Ad-RTS-IL-12 and veledimex demonstrate a unique ability to overcome these barriers by localizing and tightly controlling expression of the potent cytokine interleukin-12. Our preclinical data to date demonstrate both a precisely controlled biologic response using this gene expression system as well as a remarkable effect on these tumors, suggesting further evaluation in the clinic. We expect to initiate a multicenter Phase 1 study in the first half of next year, and look forward to understanding the clinical potential of this therapy in brain cancers.”
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression and control technology to deliver DNA for the treatment of cancer. ZIOPHARM’s technology platform employs Intrexon Corporation’s RheoSwitch Therapeutic System® platform to turn on and off, and precisely modulate, gene expression at the cancer site in order to improve the therapeutic index. This technology is currently being evaluated in Phase 2 clinical studies of the immune system cytokine interleukin-12 for the treatment of breast cancer and advanced melanoma. Multiple new Investigational New Drug applications for new targets using synthetic biology technology with monogenic and multigenic approaches are expected in 2014 and 2015. ZIOPHARM is also developing novel small molecules as potential cancer therapeutics.
SOURCE: ZIOPHARM Oncology
Post Views: 182
