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Ziopharm Oncology Completes Enrollment of Controlled IL-12 plus Opdivo® (nivolumab) Phase 1 Combination Trial in Brain Cancer | ||
By: Nasdaq / GlobeNewswire - 26 Jun 2019 | Back to overview list |
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– Enrollment completed in third cohort of dose-escalation study at leading brain cancer hospitals in US; Investigators indicate interest in expanding study – BOSTON, June 26, 2019 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) today announced completion of enrollment of the third cohort of a phase 1 clinical trial evaluating Controlled IL-12 (Ad-RTS-hIL-12 plus veledimex, Ad+V), in combination with the PD-1 inhibitor OPDIVO® (nivolumab) for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults. Investigators from this multi-center trial, conducted at Northwestern University in Chicago, Brigham and Women’s Hospital in Boston, and The University of Texas MD Anderson Cancer Center in Houston, have indicated interest in expanding the study and the Company now expects to enroll additional patients at the highest dosing level, subject to final agreement by the Data and Safety Monitoring Board. “We are pleased to complete enrollment of the dose escalation of Ad-RTS-hIL-12 + veledimex and nivolumab and explore the potential to expand this combination trial to further enrich our clinical experience,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “The enthusiasm for combining PD-1 inhibitors with IL-12 in the current study is evident, and we also look forward to initiating a phase 2 trial with Ad-RTS-hIL-12 plus veledimex and cemiplimab in the coming days.” Ziopharm’s Controlled IL-12 platform is an investigational gene therapy designed to induce and control the production of human interleukin 12 (hIL-12) a master-regulator of the immune system. In the setting of rGBM, the Company is leveraging the anti-tumor effects for Controlled IL-12 as monotherapy by combining with PD-1 inhibitors. Previously reported data from serial biopsies in patients with rGBM revealed that Controlled IL-12 results in sustained influx of T cells and upregulation of PD-1 expression, providing a compelling rationale for this combination. Initial phase 1 data from this trial were presented at the American Society for Clinical Oncology (ASCO) Annual Meeting on June 2, 2019, showing Controlled IL-12 can be combined with PD-1 inhibitor OPDIVO and the initial data were consistent with immune mediated anti-tumor effects with a favorable safety profile. Ziopharm anticipates reporting on further data from this combination trial (Clinicaltrials.gov NCT03636477) at medical meetings later this year and into 2020. About Ad-RTS-hIL-12 plus veledimex At the 2018 annual meeting of the Society for Neuro-Oncology, Ziopharm presented data from its phase 1 dose-escalation trial showing that Controlled IL-12 (Ad-RTS-hIL-12 plus veledimex) had a positive survival benefit, with 15 patients who received 20mg veledimex reaching 12.7 months median overall survival (mOS) at a mean follow up of 13.1 months. A subset of these patients (n=6) who received low-dose steroids (20mg or less of dexamethasone cumulatively over 15 days while receiving veledimex) had mOS of 17.8 months compared to 6.4 months mOS for patients (n=9) who received more than 20mg of dexamethasone during the same period. The survival data from patients who received the preferred dosing regimen of Controlled IL-12 with 20mg veledimex and low-dose steroids compare favorably to a benchmark mOS of 6 to 9 months for patients with rGBM that serves as historical control. In February 2019, the Company announced that it rapidly completed enrollment and treated 36 additional patients at 20mg veledimex dosing in less than six months in a substudy (Clinicaltrials.gov NCT03679754) to expand a phase 1 trial evaluating its Controlled IL-12 platform as a monotherapy for the treatment of rGBM. A majority (75%) of patients enrolled in the substudy were treated with low-dose steroids. At ASCO 2019, the Company presented data which confirmed that local, regulated IL-12 production using Ad+V in subjects with rGBM rapidly and safely activates the immune system, with adverse reactions consistent and predictable to those seen in prior studies, and promptly reversible upon discontinuation of veledimex. Mean follow-up was 3.7 months. About Ad-RTS-hIL-12 plus veledimex in combination with PD-1 inhibitors FDA Fast Track Designation Learn more about Controlled IL-12 online at https://ziopharm.com/controlled-il-12/. About Ziopharm Oncology, Inc. Note Regarding Forward-Looking Statements Contact:
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