Drugs / AsiDNA
AsiDNA
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03579628 | Apr 2018 → Feb 2021 | — | Valerio Therapeutics | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05700669 | Feb → Oct 2023 | breast cancer, malignant epithelial tumor of ovary, prostate carcinoma | Valerio Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT05394558 | May 2022 → Sep 2023 | malignant glioma | Institut Curie | Terminated | No outcome recorded |
| Phase 1/2 | NCT04826198 | Oct 2020 → Apr 2024 | ovarian cancer | Gustave Roussy, Cancer Campus, Grand Paris | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-06-30 | Valerio Therapeutics | Regulatory Initial IND application for AsiDNA Granted “Study May Proceed” by the U.S. FDA valeriotx.com ↗
Initial IND application for AsiDNA Granted “Study May Proceed” by the U.S. FDA |
| 2022-03-09 | Valerio Therapeutics | Results Onxeo’s new preclinical data confirm the relevance of combining AsiDNA™ with PARP inhibitors in treating homologous recombination proficient tumors valeriotx.com ↗
The data presented by Onxeo highlight the therapeutic opportunity of combining AsiDNA™ and PARPi in HRP tumors to overcome intrinsic or acquired resistance in clinical situation. |
| 2021-08-12 | Valerio Therapeutics | Results New preclinical data confirm the ability of AsiDNA™ to tackle the drug-tolerant persister cells and prevent tumor resistance in several combination treatments valeriotx.com ↗
The data presented by Onxeo show that the addition of AsiDNA™ to targeted therapies prevents the regrowth of the DTP cells, thereby completely and irreversibly abolishing the emergence of resistance in tumor cells. |
| 2020-11-09 | Valerio Therapeutics | Results Onxeo Announces Completion of Patient Enrollment in DRIIV-1b Study and Positive Interim Results valeriotx.com ↗
Of the first seven patients, four had a partial response or longer periods of control of their disease than with previous treatment lines; three patients are still being treated. |
| 2020-08-27 | Valerio Therapeutics | Results Onxeo Reports Publication of Final Results of DRIIV Phase 1 Dose-Escalation Study of AsiDNA™ in Advanced Solid Tumors in the British Journal of Cancer valeriotx.com ↗
DRIIV was instrumental in demonstrating the good safety profile and activity of AsiDNA™ via the IV route. |
| 2019-11-13 | Valerio Therapeutics | Results Onxeo Announces Publication of Preclinical Study Results Comparing Efficacy and Toxicity of olaparib and AsiDNA™ in Frontiers in Oncology valeriotx.com ↗
In-vivo models showed that, while both DNA repair inhibitors were effective, only AsiDNA™ could delay resistance to carboplatin without increasing its toxicity. |
| 2019-10-15 | Valerio Therapeutics | Results Onxeo to Present Final Results of DRIIV-1 Phase 1 Study of AsiDNA™ in Advanced Solid Tumors at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics valeriotx.com ↗
DRIIV-1 demonstrated AsiDNA’s favorable safety profile and validated its mechanism of action in patients’ tumor cells through the activation of its biological targets. |
| 2019-09-18 | Valerio Therapeutics | Results Onxeo announces positive intermediate results from the first part of the DRIIV-1b study evaluating AsiDNA™ in combination with chemotherapy valeriotx.com ↗
Onxeo announces positive intermediate results from the first part of the DRIIV-1b study evaluating AsiDNA™ in combination with chemotherapy |
| 2019-05-28 | Valerio Therapeutics | Results Onxeo announces final positive data from DRIIV-1 Phase 1 Study of AsiDNA™ in Advanced Solid Tumors valeriotx.com ↗
Importantly, the optimal active dose of AsiDNA ™ has been determined and is being utilized in our ongoing DRIIV-1b study combining AsiDNA™ with chemotherapy. |
| 2019-02-13 | Valerio Therapeutics | Results Onxeo to Present Five Preclinical Studies Highlighting AsiDNA™ Unique Profile and its clinical potential in Oncology at 2019 American Association for Cancer Research Annual Meeting valeriotx.com ↗
New data also provide valuable insights into the underlying mechanisms supporting these unique outcomes and their potential benefits in oncology. |
| 2019-01-03 | Valerio Therapeutics | Results Onxeo Announces Identification of Predictive Biomarkers for AsiDNA™, its First-in-Class DNA Damage Response Inhibitor valeriotx.com ↗ |
All press releases naming this drug 17 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AsiDNA | “Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously” NCT04826198 ↗4“All patients will receive a loading dose of AsiDNA intravenously” NCT05700669 ↗ |
| Known as | AsiDNATM | “Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously” NCT04826198 ↗ |
| Known as | etidaligide | “Patients will receive the IMP which is the AsiDNA (etidaligide).” NCT05394558 ↗ |
| Action | Inhibit | “AsiDNATM, a DNA Repair Inhibitor” NCT04826198 ↗ |
| Modality | Oligonucleotide (other) | “AsiDNA, a first-in-class oligonucleotide-mimicking double-stranded DNA breaks” PMID 32839491 ↗ Aug 2020 |
| Route | Intravenous | “administered intravenously” NCT03579628 ↗ |