BOSTON, MA, USA I July 19, 2016 I ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today provided an update regarding the Company’s ongoing multicenter Phase I study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma (GBM) or grade III malignant glioma.
The patient death resulting from intracranial hemorrhage in the third cohort of this Phase I study was deemed unrelated to study drug following the receipt and analysis of additional information by the sponsor and the study’s Safety Review Committee. As with all study events, the Company expects to report the data to the U.S. Food and Drug Administration in accordance with the study’s protocol and applicable regulations. As previously announced, the study remains open for enrollment. The Company expects to provide further updates on the progress of the study, including longer-term survival follow up, at an appropriate meeting later this year.
“Recurrent GBM is a devastating disease with an expected overall survival that remains far too short as this case illustrates,” said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. “Preliminary overall survival in this study, including a median follow-up of over 8 months in the first dose cohort, remain encouraging, and we will continue to work diligently toward understanding the full potential of Ad-RTS-hIL-12 + veledimex in this disease, with the goal of providing safe and effective treatment options to these patients.”
About Glioblastoma
Glioblastoma is an aggressive primary brain tumor affecting approximately 74,000 people worldwide each year.i, ii Recurrent glioblastoma is an aggressive cancer with one of the lowest 3-year survival rates, at 3%, among all cancers.iii For patients who have experienced multiple recurrences the prognosis is particularly poor, with a median overall survival (OS) of 6-7 months, while OS in patients that have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy, is approximately 3-5 months.iv, v
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer. The Company’s immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE: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® 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 Oncology
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BOSTON, MA, USA I July 19, 2016 I ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today provided an update regarding the Company’s ongoing multicenter Phase I study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma (GBM) or grade III malignant glioma.
The patient death resulting from intracranial hemorrhage in the third cohort of this Phase I study was deemed unrelated to study drug following the receipt and analysis of additional information by the sponsor and the study’s Safety Review Committee. As with all study events, the Company expects to report the data to the U.S. Food and Drug Administration in accordance with the study’s protocol and applicable regulations. As previously announced, the study remains open for enrollment. The Company expects to provide further updates on the progress of the study, including longer-term survival follow up, at an appropriate meeting later this year.
“Recurrent GBM is a devastating disease with an expected overall survival that remains far too short as this case illustrates,” said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. “Preliminary overall survival in this study, including a median follow-up of over 8 months in the first dose cohort, remain encouraging, and we will continue to work diligently toward understanding the full potential of Ad-RTS-hIL-12 + veledimex in this disease, with the goal of providing safe and effective treatment options to these patients.”
About Glioblastoma
Glioblastoma is an aggressive primary brain tumor affecting approximately 74,000 people worldwide each year.i, ii Recurrent glioblastoma is an aggressive cancer with one of the lowest 3-year survival rates, at 3%, among all cancers.iii For patients who have experienced multiple recurrences the prognosis is particularly poor, with a median overall survival (OS) of 6-7 months, while OS in patients that have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy, is approximately 3-5 months.iv, v
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer. The Company’s immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE: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® 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 Oncology
Post Views: 252
