On May 17, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported that it will present updated results from its Phase 1, multicenter, dose-escalation study and 20-mg expansion cohort of Ad-RTS-hIL-12 + orally administered veledimex in patients with recurrent or progressive glioblastoma (GBM) at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 2-6 in Chicago (Press release, Ziopharm, MAY 17, 2017, View Source [SID1234519203]). Ad-RTS-hIL-12 + veledimex is a novel, viral gene therapy candidate for the controlled expression of interleukin-12 (IL-12), a pro-inflammatory cytokine critical for stimulating anti-cancer immune responses. Schedule your 30 min Free 1stOncology Demo! As noted in the abstract released today, subjects with recurrent or progressive grade III or IV glioma undergoing resection were intratumorally injected with 2 x 1011 adenovirus (Ad) particles and received veledimex for 15 daily doses, beginning just prior to surgery. The primary endpoint of the study was safety and tolerability of Ad-RTS-hIL-12 + veledimex, with secondary endpoints including overall survival. Updated results will be presented at the meeting on June 5.
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Glioblastoma is an aggressive brain tumor affecting approximately 74,000 people worldwide annually.i,ii Patients with recurrent GBM typically have a median overall survival (mOS) of 6-7 months, and overall survival in patients who have failed temozolomide, bevacizumab or equivalent salvage chemotherapy, is approximately 3-5 months.iii,iv
"Recurrent glioblastoma is a rapidly progressing disease with no standard of care and extremely poor prognoses, and thus there is an urgent need for new treatment options," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We look forward to updating results from this study at ASCO (Free ASCO Whitepaper) and to soon advancing Ad-RTS-hIL-12 + veledimex into additional treatment settings, including a stereotactic arm, a pediatric trial in diffuse intrinsic pontine glioma patients and a combination study with an immune checkpoint inhibitor. We also continue to assess several paths for the initiation of a pivotal trial and look forward to providing updates on this strategy following completion of discussions with regulators and clinical advisors."
Details for the poster presentation at ASCO (Free ASCO Whitepaper) 2017:
Title: Expanded phase I study of intratumoral Ad-RTS-hIL-12 plus oral veledimex: Tolerability and survival in recurrent glioblastoma
Abstract Number: 2044
Session: Central Nervous System Tumors
Date and Time: Monday, June 5, 2017, 1:15 — 4:45 p.m. CT