On July 15, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported the following statement regarding the Company’s ongoing multicenter Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma (GBM) or grade III malignant glioma:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This Phase I study is being conducted in late-stage, recurrent GBM, so these patients are all, unfortunately, medically fragile. The first two patient deaths, which occurred 6.7 months and 3.9 months after treatment, were unrelated to study drug (Press release, Ziopharm, JUL 15, 2016, View Source [SID:1234513900]). A third death has just been reported to us and we are collecting and analyzing information in order to properly and timely report it to the FDA. The cause of death is intracranial hemorrhage, which occurred some time after the patient had been discharged from the treating center. This is an isolated case, and there have been no reported related instances of brain hemorrhage in any pervious cohort or prior studies with Ad-RTS-hIL-12 + veledimex. Enrollment remains open in the study, and we will be discussing with our Safety Review Committee the appropriate course of action. For patients who have experienced multiple recurrences, as these patients have, prognoses are particularly poor. Median follow up in the first dose cohort from our study is now 8 months, in a population with an expected overall survival of 3 to 5 months for patients that have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy. For the patients that remain in follow up in this Phase I study, we believe that preliminary overall survival remains encouraging. The Company expects to provide an update once a course of action has been determined."
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