Drugs / NIBROZETONE
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04525014 | Jan 2023 → Jul 2024 | brain cancer, childhood malignant neoplasm | EpicentRx, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02871843 | Feb 2017 → Oct 2019 | anaplastic oligodendroglioma, glioblastoma, oligodendroglioma | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02801097 | Aug 2016 → Nov 2018 | metastatic malignant neoplasm | EpicentRx, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02518958 | Jul 2015 → May 2016 | cancer, lymphoma | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02215512 | Feb 2015 → Nov 2016 | metastatic malignant neoplasm in the brain | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02096341 | Apr 2014 → Jan 2016 | cancer, lymphoma | EpicentRx, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01359982 | Sep 2011 → Feb 2015 | cancer, lymphoma | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT05966194 | Apr 2024 → Jul 2027 expected | mucositis | EpicentRx, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03515538 | Jul 2018 → Oct 2019 | chemotherapy-induced oral mucositis | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02452970 | Jul 2015 → May 2016 | cholangiocarcinoma | EpicentRx, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02489903 | Jun 2015 → Dec 2021 | malignant epithelial tumor of ovary, non-small cell lung carcinoma, small cell carcinoma | EpicentRx, Inc. | Completed | Met primary |
| Phase 2 | NCT02096354 | May 2014 → Apr 2018 | colorectal cancer | EpicentRx, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05566041 | Aug 2022 → Dec 2025 overdue | small cell lung carcinoma | EpicentRx, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03699956 | Dec 2018 → Aug 2022 | small cell lung carcinoma | EpicentRx, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-06-16 | SciClone Pharmaceuticals | Results 赛生药业 RRx-001 III期临床研究研究者协调会成功召开 sciclone.com ↗
截至目前RRx-001在中国小细胞肺癌患者中表现出良好的耐受性和初步的疗效获益，患者最长用药时间已超过7个月。 |
| 2023-03-29 | EpicentRx, Inc. | Regulatory EpicentRx Receives Fast Track Designation from the U.S. FDA for Lead Asset, RRx-001, to Prevent/Attenuate Chemotherapy and Radiation Treatment Induced Severe Oral Mucositis epicentrx.com ↗ |
| 2023-03-28 | EpicentRx, Inc. | Results EpicentRx To Present at International Symposium on the Neuroprotective Effects of RRx-001 in Alzheimer’s and Parkinson’s diseases in Multiple Disease Models epicentrx.com ↗
RRx-001, A DIRECT NLRP3 INHIBITOR AND PHASE 3 SMALL MOLECULE IMPROVES ALZHEIMER’S AND PARKINSON’S PATHOLOGY IN MULTIPLE DISEASE MODELS |
| 2023-03-15 | EpicentRx, Inc. | Results Promising Safety and Efficacy Signals from a Small Phase 1 Pilot Study (PRIMETIME) with RRx-001 + Opdivo® [nivolumab] in Traditionally Checkpoint Inhibitor Non-Responsive Tumors epicentrx.com ↗
The combination treatment was well tolerated with no dose limiting toxicities and demonstrated an unconfirmed response rate of 25% and a disease control rate of 67% across four different dose levels in 12 heavily pre-treated patients with non-immunogenic tumor types. |
| 2023-02-15 | EpicentRx, Inc. | Results EpicentRx Presents Poster on the Nephroprotective Effects of RRx-001 in Patients with Solid Tumors that Receive Cisplatin/Etoposide at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium epicentrx.com ↗ |
| 2023-01-20 | EpicentRx, Inc. | Results EpicentRx Announces Presentation for Phase 2 Randomized, Active-controlled, Multicenter Trial to Assess the Safety and Efficacy of RRx-001 vs. regorafenib in Third/Fourth Line Colorectal Cancer at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium epicentrx.com ↗
Positive results from the completed Phase 2 study demonstrate improved overall survival and significantly improved progression free survival of RRx-001 plus irinotecan compared with regorafenib in 3 rd /4 th line colorectal cancer. |
| 2023-01-19 | EpicentRx, Inc. | Results EpicentRx Publishes Phase 2 Results for RRx-001 as an Anti-Mucositis Agent in Patients Receiving Radiation for Head and Neck Cancers epicentrx.com ↗
Results from PREVLAR trial Demonstrate RRx-001 protects against severe oral mucositis or blistering from radiation in first line head and neck cancer |
| 2022-12-14 | EpicentRx, Inc. | Results RRx-001 + Irinotecan Significantly Improved Progression Free Survival (PFS) Versus Regorafenib in the Randomized Phase 2 ROCKET Trial in Advanced Colorectal Cancer epicentrx.com ↗
The median overall survival was 8.6 months for RRx-001 plus irinotecan and 4.7 months for regorafenib. |
| 2022-05-27 | EpicentRx, Inc. | Results EpicentRx Announces Poster Presentation for Phase 2 Randomized Clinical Trial with RRx-001 as an Anti-Mucositis Agent in Locally Advanced Head and Neck Cancer at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting epicentrx.com ↗
Positive results from the completed Phase 2 study called PREVLAR |
| 2021-10-28 | EpicentRx, Inc. | Results EpicentRx Announces Publication of Phase 1 Trial Results for the Anti-Cancer Agent, RRx-001, in Lancet Oncology epicentrx.com ↗
EpicentRx, Inc., a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of potent, novel anti-cancer agents, announced today the publication of positive results from its Phase 1 clinical trial of RRx-001. |
| 2019-11-25 | EpicentRx, Inc. | Results EpicentRx Announces Positive Results From Phase 1 Trial of RRx-001 as First-line Treatment in Newly Diagnosed Glioblastoma epicentrx.com ↗
RRx-001 combination therapy led to an overall survival (OS) of 21.9 months, compared with historical OS data of 15-20 months. |
| 2019-06-25 | EpicentRx, Inc. | Results EpicentRx Announces Publication of Its Positive Phase 2 3rd Line SCLC Results With RRx-001 Plus a Platinum Doublet in the British Journal of Cancer (BJC) epicentrx.com ↗
EpicentRx Inc. , a clinical-stage immuno-oncology company with two platforms developed to prime and activate both innate and adaptive anticancer responses, today announced the publication of positive results from its Phase 2 clinical trial of RRx-001, a tumor associated macrophage (TAM) repolarizing agent, in small cell lung cancer (SCLC). |
All press releases naming this drug 27 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NIBROZETONE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3526802 ↗ |
| Known as | Abdnaz | ChEMBL registry synonym — accepted as the source's own label CHEMBL3526802 ↗ |
| Known as | Bromonitrozidine | “Bromonitrozidine (RRx-001) is a minimally toxic, NLRP3 inhibitor” PMID 36960054 ↗ Mar 2023 |
| Known as | Nibrozetona | ChEMBL registry synonym — accepted as the source's own label CHEMBL3526802 ↗ |
| Known as | Radiosensitizer rrx-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3526802 ↗ |
| Known as | RRx-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03699956 ↗ |
| Action | Activate | “turns on a number of beneficial genes” NCT02452970 ↗ |
| Modality | Other / unclassified | “INTRODUCTION: RRx-001 is a novel cysteine-targeted alkylating agent that releases nitric oxide (NO).” PMID 36529613 ↗ Dec 2022 |
| Route | Intravenous | “Patients were assigned to receive intravenous infusions of RRx-001 at increasing doses” PMID 26296952 ↗ Aug 2015 |
| Target | CD47 | “RRx-001 is a small molecule Myc inhibitor and down-regulates CD47 expression on tumor cells.” PMID 33569311 ↗ Jan 2021 |
| Target | MYC | “RRx-001 is a small molecule Myc inhibitor and down-regulates CD47 expression on tumor cells.” PMID 33569311 ↗ Jan 2021 |