BOSTON, MA, USA I May 5, 2015 I ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the initiation of a Phase 1 study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma or Grade III malignant glioma, a form of brain cancer. Ad-RTS-hIL-12 is a novel gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response.
The Phase 1 study is designed to examine a gene therapy treatment strategy for high grade gliomas with the goal of generating an anti tumor T cell immune response. Eligible patients will be stratified to one of two groups, according to clinical indication for tumor resection. One group will undergo resection plus injection and the other group will undergo stereotactic injection. Ad-RTS-hIL-12 will be injected locally in the tumor lesion, with IL-12 expression levels tightly regulated by escalating doses of the oral activator ligand veledimex. This strategy makes it feasible to control the gene therapy in vivo and to lower or terminate IL-12 expression in the event of severe or unexpected toxicities. The primary objective of the study is to determine the safety and tolerability of a single intra tumoral Ad-RTS-hIL-12 injection plus escalating oral veledimex doses. Secondary Objectives are to determine the veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 and veledimex, and investigator assessment of response, including the tumor objective response rate and progression-free survival, and determine overall survival, among other measures.
The study is expected to enroll up to 72 subjects at up to 12 leading treatment centers. Among the centers expected to begin enrollment are the Stanford School of Medicine, Dana Farber/Brigham and Women’s, the University of Chicago Pritzker School of Medicine, Cedars-Sinai/the David Geffen School of Medicine at the University of California, Los Angeles, and Northwestern Memorial Hospital.
“Recurrent or progressive glioblastoma and malignant glioma are associated with a particularly aggressive course and dismal prognosis,” said Maciej S. Lesniak, MD, MHCM, Professor of Surgery and Neurology, Director, Neurosurgical Oncology, Director, Neuro-Oncology Research, University of Chicago Pritzker School of Medicine. “The current standard of care treatment is based on surgical resection, which is limited by the infiltrative nature of the disease and the lack of clear margins delimitating the tumor. Given the poor overall prognosis and lack of effective treatments, new therapeutic approaches are urgently needed. Ad-RTS-IL-12 has demonstrated very promising preclinical efficacy.”
“Evidence that IL-12 is able to trigger innate and adaptive immunity and collapse tumor stroma supports its relevance as an important immunotherapeutic agent,” 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 Women’s Hospital and Co-Director, Institute for the Neurosciences, Brigham And Women’s Hospital. “The preclinical data shows that Ad-RTS-IL-12 gene therapy could be a highly promising novel treatment for GBM.”
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safer, more effective and scalable cell-based therapies for the treatment of cancer. The Company’s synthetic immuno-oncology programs, in collaboration with Intrexon Corporation (XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation’s RheoSwitch Therapeutic System(R) technology, a switch to turn on and off, and precisely modulate, gene expression in order to improve therapeutic index. The Company’s pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.
SOURCE: ZIOPHARM
Post Views: 292
BOSTON, MA, USA I May 5, 2015 I ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the initiation of a Phase 1 study of Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive glioblastoma or Grade III malignant glioma, a form of brain cancer. Ad-RTS-hIL-12 is a novel gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response.
The Phase 1 study is designed to examine a gene therapy treatment strategy for high grade gliomas with the goal of generating an anti tumor T cell immune response. Eligible patients will be stratified to one of two groups, according to clinical indication for tumor resection. One group will undergo resection plus injection and the other group will undergo stereotactic injection. Ad-RTS-hIL-12 will be injected locally in the tumor lesion, with IL-12 expression levels tightly regulated by escalating doses of the oral activator ligand veledimex. This strategy makes it feasible to control the gene therapy in vivo and to lower or terminate IL-12 expression in the event of severe or unexpected toxicities. The primary objective of the study is to determine the safety and tolerability of a single intra tumoral Ad-RTS-hIL-12 injection plus escalating oral veledimex doses. Secondary Objectives are to determine the veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 and veledimex, and investigator assessment of response, including the tumor objective response rate and progression-free survival, and determine overall survival, among other measures.
The study is expected to enroll up to 72 subjects at up to 12 leading treatment centers. Among the centers expected to begin enrollment are the Stanford School of Medicine, Dana Farber/Brigham and Women’s, the University of Chicago Pritzker School of Medicine, Cedars-Sinai/the David Geffen School of Medicine at the University of California, Los Angeles, and Northwestern Memorial Hospital.
“Recurrent or progressive glioblastoma and malignant glioma are associated with a particularly aggressive course and dismal prognosis,” said Maciej S. Lesniak, MD, MHCM, Professor of Surgery and Neurology, Director, Neurosurgical Oncology, Director, Neuro-Oncology Research, University of Chicago Pritzker School of Medicine. “The current standard of care treatment is based on surgical resection, which is limited by the infiltrative nature of the disease and the lack of clear margins delimitating the tumor. Given the poor overall prognosis and lack of effective treatments, new therapeutic approaches are urgently needed. Ad-RTS-IL-12 has demonstrated very promising preclinical efficacy.”
“Evidence that IL-12 is able to trigger innate and adaptive immunity and collapse tumor stroma supports its relevance as an important immunotherapeutic agent,” 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 Women’s Hospital and Co-Director, Institute for the Neurosciences, Brigham And Women’s Hospital. “The preclinical data shows that Ad-RTS-IL-12 gene therapy could be a highly promising novel treatment for GBM.”
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safer, more effective and scalable cell-based therapies for the treatment of cancer. The Company’s synthetic immuno-oncology programs, in collaboration with Intrexon Corporation (XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation’s RheoSwitch Therapeutic System(R) technology, a switch to turn on and off, and precisely modulate, gene expression in order to improve therapeutic index. The Company’s pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.
SOURCE: ZIOPHARM
Post Views: 292
