Drugs / veledimex
veledimex
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03679754 | Sep 2018 → Apr 2019 | glioblastoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03636477 | Jun 2018 → Oct 2020 | glioblastoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02026271 | Jun 2015 → Aug 2019 | anaplastic oligoastrocytoma, glioblastoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00815607 | Apr 2009 → Jan 2013 | melanoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03740724 | Dec 2019 → Sep 2020 | localized scleroderma | Castle Creek Biosciences, LLC. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03330197 | Sep 2017 → Sep 2021 | diffuse intrinsic pontine glioma | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02423902 | Jul 2015 → Jul 2016 | breast cancer | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01397708 | Aug 2011 → Sep 2014 | melanoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04006119 | Aug 2019 → Aug 2021 | glioblastoma | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01703754 | Apr 2013 → Aug 2014 | breast carcinoma | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2020-11-19 | Alaunos Therapeutics | Results Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Glioblastoma and DIPG at the 2020 Society for Neuro-Oncology Annual Meeting alaunos.com ↗
Updated Interim Data from Ongoing Phase 1 Study of Controlled IL-12 in Combination with Nivolumab Show a mOS of 16.9 Months in Patients Receiving 10 mg Veledimex |
| 2020-09-14 | Alaunos Therapeutics | Regulatory Ziopharm Oncology Granted Rare Pediatric Disease Designation for Controlled IL-12 for the Treatment of DIPG alaunos.com ↗
BOSTON , Sept. 14, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology , Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Ad-RTS-hIL-12 with veledimex (Controlled IL-12) for the investigational treatment of diffuse intrinsic pontine glioma (DIPG), a lethal brain tumor occurring in the pontine region of the brain. |
| 2020-05-29 | Alaunos Therapeutics | Results Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Recurrent Glioblastoma at the 2020 American Society of Clinical Oncology alaunos.com ↗ |
| 2019-11-23 | Alaunos Therapeutics | Results Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Recurrent Glioblastoma at the 2019 Society for Neuro-Oncology Annual Meeting alaunos.com ↗
These data support Ziopharm’s continued development of its Ad-RTS-hIL-12 plus veledimex as a drug to control the production of IL-12 as monotherapy and in combination with PD-1 inhibition. |
| 2019-08-14 | Alaunos Therapeutics | Results Ziopharm Oncology Announces Publication of Positive Results of Phase 1 Monotherapy Trial of Controlled IL-12 in Patients with Recurrent Glioblastoma in Science Translational Medicine alaunos.com ↗ |
| 2019-08-08 | Alaunos Therapeutics | Regulatory Ziopharm Oncology Receives Positive Opinion for Orphan Drug Designation from the European Medicines Agency for Ad-RTS-hIL-12 plus Veledimex for the Treatment of Glioma alaunos.com ↗
We are pleased to receive a positive opinion from EMA COMP for orphan drug designation, as this represents another important milestone for our clinical program to treat recurrent glioblastoma multiforme. |
| 2019-06-02 | Alaunos Therapeutics | Results Ziopharm Oncology Provides Positive Clinical Data for Controlled IL-12 for the Treatment of Recurrent Glioblastoma at the 2019 ASCO Annual Meeting alaunos.com ↗
Furthermore, we demonstrate that Controlled IL-12 can be combined with a PD-1 inhibitor and the initial data from this phase 1 trial are consistent with immune-mediated anti-tumor effects with a favorable safety profile. |
| 2019-04-01 | Alaunos Therapeutics | Regulatory Ziopharm Oncology Announces FDA Fast Track Designation for Ad-RTS-hIL-12 plus Veledimex for the Treatment of Recurrent Glioblastoma alaunos.com ↗
BOSTON , April 01, 2019 (GLOBE NEWSWIRE) -- Ziopharm Oncology , Inc. (Nasdaq: ZIOP), a clinical stage immuno-oncology company developing next generation cell and gene therapies, today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track Designation for its Controlled IL-12 program, or Ad-RTS-hIL-12 plus veledimex, for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults. |
| 2018-11-16 | Alaunos Therapeutics | Results Ziopharm Oncology Provides Controlled IL-12 Update with Positive Data from Phase 1 Trial Presented at Annual Meeting of the Society for Neuro-Oncology alaunos.com ↗
Phase 1 data has shown that Ad-RTS-hIL-12 with a 20mg dose of veledimex and less than 20mg of the steroid dexamethasone is the preferred dosing regimen to treat patients with rGBM. |
| 2018-06-04 | Alaunos Therapeutics | Results Ziopharm Oncology Presents Clinical Data Demonstrating Anti-tumor Immune Response of Controlled IL-12 Platform in Breast Cancer and Glioblastoma at American Society of Clinical Oncology (ASCO) Annual Meeting alaunos.com ↗ |
| 2018-05-16 | Alaunos Therapeutics | Results Ziopharm Oncology to Present Data from Clinical Studies of Controlled IL-12 in Breast Cancer and Glioblastoma at American Society of Clinical Oncology (ASCO) Annual Meeting alaunos.com ↗
Data from biopsies shows Ad-RTS-hIL-12 plus veledimex recruits killer T cells into breast and brain cancers |
| 2017-11-20 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Updated Results of Ad-RTS-hIL-12 Study in Brain Cancer at Society for Neuro-Oncology Annual Meeting alaunos.com ↗
New data presented shows median overall survival (mOS) of 12.5 months has been sustained for patients treated with Ad-RTS-hIL-12 plus 20mg of veledimex (n=15) at a longer mean follow-up time of 11.1 months as of October 18, 2017. |
| 2017-11-06 | Alaunos Therapeutics | Results ZIOPHARM Announces Four Presentation Abstracts at the 2017 Annual Meeting of the Society for Neuro-Oncology alaunos.com ↗
In our Phase 1, multi-centric study of Ad-RTS-hIL-12 plus veledimex, we continue to show a marked improvement of survival in patients with recurrent glioblastoma over historical controls. |
| 2017-09-18 | Alaunos Therapeutics | Results ZIOPHARM Oncology Announces Updated Findings from Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma Presented at American Academy of Neurological Surgery Annual Meeting alaunos.com ↗
These updated immunohistochemistry data on top of promising survival underscore the possible immunomodulatory benefits of localized and controlled IL-12 and support the advancement of this therapy candidate into a larger outcome study. |
| 2017-06-05 | Alaunos Therapeutics | Results ZIOPHARM Oncology Announces Positive Updated Results of Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma at the 2017 ASCO Annual Meeting alaunos.com ↗
As of May 24, 2017, the cutoff date for the ASCO presentation, median overall survival (mOS) of all patients receiving intratumoral Ad-RTS-hIL-12 with 20 mg of orally-administered veledimex was maintained at 12.5 months, with a mean follow-up time of 9.2 months. |
| 2016-11-17 | Alaunos Therapeutics | Results ZIOPHARM Announces Clinical Data on Ad-RTS-hIL-12 Demonstrates Survival Benefits in Patients with Recurrent Brain Cancer alaunos.com ↗ |
| 2016-10-10 | Alaunos Therapeutics | Results ZIOPHARM Presents Data Demonstrating Activation of Anti-Tumor Immune Response Using Ad-RTS-hIL-12 in Patients with Advanced Breast Cancer alaunos.com ↗
Results show that Ad-RTS-hIL-12 + 7 days of veledimex consistently elicited production of IL-12 which in turn produced IFNγ. |
| 2016-07-19 | Alaunos Therapeutics | Results ZIOPHARM Provides Update Regarding Phase I Study of Gene Therapy Candidate Ad-RTS-hIL-12 in Brain Cancer alaunos.com ↗
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. |
| 2016-07-15 | Alaunos Therapeutics | Results ZIOPHARM Issues Statement Regarding Phase I Study of Gene Therapy Candidate Ad-RTS-hIL-12 in Brain Cancer alaunos.com ↗
For the patients that remain in follow up in this Phase I study, we believe that preliminary overall survival remains encouraging. |
| 2016-05-18 | Alaunos Therapeutics | Results ZIOPHARM Announces Clinical Data Highlighting Favorable Interim Survival Results with Gene Therapy Candidate Ad-RTS-hIL-12 in Brain Cancer alaunos.com ↗
ZIOPHARM Announces Clinical Data Highlighting Favorable Interim Survival Results with Gene Therapy Candidate Ad-RTS-hIL-12 in Brain Cancer |
| 2016-04-18 | Alaunos Therapeutics | Results ZIOPHARM Announces Two Oral Presentations at ASGCT 19th Annual Meeting alaunos.com ↗
Results demonstrated that survival of mice treated with Ad +V and anti-PD-1 therapy was superior to either treatment alone; |
| 2015-09-18 | Alaunos Therapeutics | Results ZIOPHARM Announces Presentation of Clinical and Preclinical Data From Ad-RTS-IL-12 at CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference alaunos.com ↗
The first poster presentation, titled, "Demonstration of Systemic Antitumor Immunity via Intratumoral Regulated Expression of IL-12 in Advanced Breast Cancer and Melanoma Patients," highlights additional evidence of systemic immune activation with AD-RTS-hIL-12 and veledimex in advanced melanoma and breast cancer patients. |
| 2015-07-24 | Alaunos Therapeutics | Regulatory ZIOPHARM Announces Orphan Drug Designation for Ad-RTS-hIL-12 in the Treatment of Malignant Glioma alaunos.com ↗
ZIOPHARM Announces Orphan Drug Designation for Ad-RTS-hIL-12 in the Treatment of Malignant Glioma |
| 2014-12-03 | Alaunos Therapeutics | Results ZIOPHARM and Intrexon Present Clinical and Preclinical Data From Immuno-Oncology Programs at AACR Tumor Immunology and Immunotherapy Meeting alaunos.com ↗
Interim clinical trial results continue to validate dose-dependent oral veledimex control of the Interleukin-12 (IL-12) gene program module and the rapid reversibility of cytokine expression and associated adverse events in patients upon withdrawal of the activator ligand. |
| 2014-05-22 | Alaunos Therapeutics | Results ZIOPHARM Announces Oral Presentation Highlighting Ad-RTS-IL-12 Results Correlated With Reducing Cancer Stem Cells in the Brain at ASGCT 17th Annual Meeting alaunos.com ↗
Rapid, tight modulation of in vivo expression of IL-12 using the activator ligand veledimex was demonstrated across these studies. |
| 2014-04-08 | Alaunos Therapeutics | Results ZIOPHARM Presents Preclinical Data at AACR Annual Meeting Supporting Controlled DNA-based IL-12 Therapy for Brain Cancer alaunos.com ↗
Veledimex was found to effectively cross the blood brain barrier, with dose-related increases in plasma and brain tissue exposure, and no accumulation in brain tissue following repeat dosing. |
| 2013-12-07 | Alaunos Therapeutics | Results ZIOPHARM Reports Positive Interim Results in Patients With Advanced Melanoma From Ongoing Phase 1/2 Study of Ad-RTS-IL-12 alaunos.com ↗
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced positive interim results from its ongoing Phase 1/2 study of Ad-RTS-IL-12, a novel DNA-based therapeutic candidate that is being evaluated with the oral activator, veledimex, in patients with advanced melanoma. |
| 2013-12-06 | Alaunos Therapeutics | Regulatory ZIOPHARM Announces Unanimous Recombinant DNA Advisory Committee (RAC) Approval for Phase 1 Study of Ad-RTS-IL-12 in Subjects With Recurrent or Progressive Glioblastoma alaunos.com ↗
ZIOPHARM Announces Unanimous Recombinant DNA Advisory Committee (RAC) Approval for Phase 1 Study of Ad-RTS-IL-12 in Subjects With Recurrent or Progressive Glioblastoma |
| 2013-10-21 | Alaunos Therapeutics | Results ZIOPHARM and Intrexon Announce Presentation of Data Highlighting Versatility of Novel Gene Expression and Control Technology alaunos.com ↗
Results demonstrated that AL brain penetration was achieved in normal mouse and monkey models. |
| 2013-06-01 | Alaunos Therapeutics | Results ZIOPHARM Announces Presentation of Updated Results From Ad-RTS-IL-12 Phase I Study in Advanced Melanoma at the 2013 ASCO Annual Meeting alaunos.com ↗
The study further demonstrated that treatment with Ad-RTS-IL-12 + INXN-1001 was shown to increase intratumoral IL-12 mRNA transcription. |
| 2013-05-16 | Alaunos Therapeutics | Results ZIOPHARM Announces Presentation of Promising Nonclinical and Phase I Study Results of Ad-RTS-IL-12 in Advanced Melanoma at ASGCT 16th Annual Meeting alaunos.com ↗
Compelling clinical activity was observed in five of seven (71 percent) patients dosed at the two highest dose levels. |
| 2013-04-09 | Alaunos Therapeutics | Results ZIOPHARM Presents Preclinical Data Supporting DNA-Based IL-12 Therapy for Breast Cancer alaunos.com ↗
Oral administration of AL was found to elicit a dose-related increase in plasma AL levels, which correlated with increasing tumor levels of AL. |
All press releases naming this drug 36 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | veledimex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03636477 ↗ |
| Known as | INXN-1001 | “evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide.” NCT01703754 ↗ |
| Known as | RG-115932 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039523 ↗ |
| Known as | VDX | “Veledimex (VDX)-regulatable interleukin-12 (IL-12) gene therapy in recurrent glioblastoma (rGBM) was reported to show tumor infiltration of CD8+ T cells, encouraging survival,...” PMID 34850166 ↗ Jun 20221“The oral activator for hIL-12, veledimex (VDX), was administered preoperatively” PMID 31413142 ↗ Aug 2019 |
| Action | Activate | “Oral activator ligand” NCT01703754 ↗ |
| Modality | Small molecule | “Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1” NCT03740724 ↗ |
| Route | Oral | “oral Activator Ligand administration” NCT00815607 ↗ |