Ziopharm Oncology Announces FDA Fast Track Designation for Ad-RTS-hIL-12 plus Veledimex for the Treatment of Recurrent Glioblastoma
“Recurrent glioblastoma multiforme is an aggressive and life-threatening cancer of the central nervous system for which there are few treatment options and no cure,” said
Data previously presented suggest that Ad-RTS-hIL-12 with 20mg veledimex improves the median overall survival (mOS) from 6 to 9 months seen with available therapies to 12.7 months, with further improvement in mOS to 17.8 months in a subset of subjects with reduced cumulative steroid exposure during the active dosing period of veledimex.
About Ad-RTS-hIL-12 plus veledimex
At the 2018 annual meeting of the
The Company has treated more than 100 patients, including more than 75 patients with rGBM, with Ad-RTS-hIL-12 plus veledimex and administered more than 1,300 doses of veledimex across three types of solid tumors, building a significant safety profile, mechanistic dataset and evidence of anti-tumor effect. Biopsy data demonstrated that Controlled IL-12 turns immunologically “cold” tumors “hot” based on sustained infiltration of killer T cells. This is likely responsible for the preliminary improved survival observed with use of Ad-RTS-hIL-12 plus veledimex as monotherapy in patients with rGBM. Biopsy data also revealed upregulation of immune checkpoints providing a compelling rationale for combining Controlled IL-12 with PD-1 inhibitors.
The Company expects to complete enrollment of a Phase 1 substudy to evaluate Controlled IL-12 in combination with the PD-1 inhibitor OPDIVO® (nivolumab) during the second quarter of this year (Clinicaltrials.gov NCT03636477). In collaboration with
In February, 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 of patients enrolled in the substudy were treated with low-dose steroids. The safety profile in the substudy is consistent with the main, Phase 1, dose-escalation study (Clinicaltrials.gov NCT02026271) in which patients received varied systemic dosing of steroids, with all adverse reactions being manageable and reversible. Altogether, the Company is now monitoring a total of 51 patients with rGBM treated with 20mg veledimex dose and to assess the impact of systemic dosing of steroids. Ziopharm anticipates reporting on preliminary data from this substudy at medical meetings this year.
Learn more about Controlled IL-12 online https://ziopharm.com/controlled-il-12/.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the potential benefits of its Controlled IL-12 program receiving Fast Track Designation to treat rGBM and the progress and timing of the development of Ziopharm’s research and development programs, including the timing for the initiation and completion of its clinical trials. Although Ziopharm’s management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in regulations, our ability to maintain the Fast Track Designation for our Controlled IL-12 program, changes in our operating plans that may impact our cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharm’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the
VP, Corporate Communications and Investor Relations
Source: ZIOPHARM Oncology Inc