Drugs / Proxinium
Proxinium
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | urinary bladder anterior wall cancer | — | “并于2019年底向FDA递交新药注册申请（NDA）” qilu-pharma.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00272181 | Jan 2006 → Oct 2007 | head and neck squamous cell carcinoma, oral cavity neoplasm | Sesen Bio, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00412776 | Dec 2005 → Apr 2008 | head and neck squamous cell carcinoma, oral cavity neoplasm | Sesen Bio, Inc. | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04859751 | Mar 2021 → Jun 2022 | urinary bladder cancer | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02449239 | Aug 2015 → May 2020 | urinary bladder cancer | Sesen Bio, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00462488 Comparator | Mar 2007 → Oct 2009 | urinary bladder cancer | Sesen Bio, Inc. | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Proxinium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00272181 ↗ |
| Known as | oportuzumab monatox | “A phase II study of oportuzumab monatox: an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with bacillus Calmette-Guérin.” PMID 22998907 ↗ Sep 2012 |
| Known as | VB4-845 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04859751 ↗ |
| Known as | Vicinium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02449239 ↗ |
| Action | Deplete | “Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death...” NCT02449239 ↗ |
| Modality | Protein / enzyme biologic | “Proxinium is a recombinant fusion protein” NCT00412776 ↗ |
| Route | Other | “Intratumoral administration of Proxinium directly to target tumors.” NCT00272181 ↗ |