Drugs / BI-505
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | plasma cell myeloma | 2016-11-08 | “a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505” bioinvent.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01025206 | Dec 2009 → Feb 2013 | plasma cell myeloma | BioInvent International AB | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02756728 | May → Dec 2016 | plasma cell myeloma | BioInvent International AB | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01838369 | Mar 2013 → Dec 2014 | smoldering plasma cell myeloma | BioInvent International AB | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2016-12-09 | BioInvent International AB | Regulatory BioInvent terminates current BI-505 Phase II study bioinvent.com ↗ |
| 2016-11-08 | BioInvent International AB | Regulatory BioInvent reports clinical hold on BI-505 phase II study bioinvent.com ↗
BioInvent International (OMXS: BINV) has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma. |
| 2014-06-24 | BioInvent International AB | Regulatory BioInvent granted US patent for BI-505 and apoptosis-inducing ICAM-1 antibodies bioinvent.com ↗
BioInvent International (OMXS: BINV) today announced that the company has been granted a US patent covering the antibody drug candidate BI-505, initially in phase II development for the treatment of multiple myeloma. |
| 2013-04-25 | BioInvent International AB | Results BioInvent Interim Report 1 January - 31 March 2013 bioinvent.com ↗
Positive results were reported in the phase I study of BI-505 in patients with multiple myeloma. |
| 2013-04-16 | BioInvent International AB | Results Preclinical data published in Cancer Cell highlight novel antibody BI-505 and potent anti-myeloma activity bioinvent.com ↗ |
| 2013-04-04 | BioInvent International AB | Results BioInvent Presents Positive Data for BI-505 at International Myeloma Congress bioinvent.com ↗
The preliminary analysis shows that BI-505 has an advantageous safety profile. |
| 2013-01-24 | BioInvent International AB | Results Positive results from the BI-505 phase I study in multiple myeloma bioinvent.com ↗
The study has reached a final stage and the preliminary analysis shows that BI-505 has an advantageous safety profile. |
| 2011-12-12 | BioInvent International AB | Results Anti-cancer activity of BI-505 demonstrated in animal model bioinvent.com ↗
Compared to untreated controls, BI-505 treated animals showed a significant reduction (p-value < 0.01) of tumour burden induced by primary human multiple myeloma cells as measured by human IgG levels. |
| 2009-08-11 | BioInvent International AB | Regulatory BioInvent Announces Approval to start Phase I Trial for BI-505 in Multiple Myeloma bioinvent.com ↗ |
| 2009-02-27 | BioInvent International AB | Results BioInvent Presents Positive Preclinical Data for BI-505 in Myeloma bioinvent.com ↗
BioInvent International AB (OMXS:BINV) today present preclinical data demonstrating anti-tumour activity of its therapeutic cancer antibody BI-505 targeting ICAM-1. |
All press releases naming this drug 18 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI-505 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01025206 ↗ |
| Action | Deplete | “potential to eliminate tumor cells” PMID 28158311 ↗ Feb 2017 |
| Modality | Monoclonal antibody | “BI-505, a human anti-ICAM-1 monoclonal antibody” PMID 25712687 ↗ Feb 2015 |
| Route | Intravenous | “BI-505 was given intravenously, every 2 weeks, at escalating doses from 0.0004 to 20 mg/kg” PMID 25712687 ↗ Feb 2015 |
| Target | ICAM1 | “BI-505, a human anti-ICAM-1 monoclonal antibody” PMID 25712687 ↗ Feb 2015 |