Drugs / Combretastatin A1 Diphosphate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | acute myeloid leukemia, myelodysplastic syndromes | 2018-08-16 | “Food and Drug Administration (FDA) placed a partial clinical hold on Study OX1222 during a telephone conversation held with the Company on August 16, 2018.” oncotelic.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00960557 | Jul 2009 → Oct 2010 | metastatic neoplasm | Mateon Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2020-09-16 | Mateon Therapeutics | Regulatory FDA Granted Pediatric Disease Designation for OXi-4503 oncotelic.com ↗ |
| 2019-12-27 | Mateon Therapeutics | Results Mateon Therapeutics Team Publishes a New Peer-Reviewed Oncology Article on the Positive Clinical Study Results for Its Lead Anti-Leukemia Drug Combretastatin A1 Plus Cytarabine in Adult Patients With Relapsed Acute Myeloid Leukemia oncotelic.com ↗
The study showed that adding OXi4503 to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. |
| 2019-12-23 | Mateon Therapeutics | Results Mateon Therapeutics Announces Positive Clinical Study Results for Its Lead Anti-Leukemia Drug Combretastatin A1 Plus Cytarabine in Adult Patients with Relapsed Acute Myeloid Leukemia oncotelic.com ↗
In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). |
| 2018-08-17 | Mateon Therapeutics | Regulatory Mateon Therapeutics Receives Notice of Partial Clinical Hold for OX1222 Study oncotelic.com ↗
The partial clinical hold applies to the 12.2 mg/m 2 dose of OXi4503. |
| 2017-07-31 | Mateon Therapeutics | Results Mateon Therapeutics Announces Positive Initial Data from Fifth Cohort of Phase 1b Study of OXi4503 in Relapsed/Refractory AML oncotelic.com ↗
Two of four patients had morphological complete remissions after one cycle of treatment with 9.76 mg/m 2 of OXi4503. |
| 2017-06-07 | Mateon Therapeutics | Regulatory Mateon Therapeutics Receives FDA Fast Track Designation for OXi4503 in Patients with Acute Myeloid Leukemia oncotelic.com ↗ |
| 2017-03-15 | Mateon Therapeutics | Results Mateon Therapeutics Announces Initial Data from Third Cohort of Phase 1b Study of OXi4503 in Relapsed/Refractory AML oncotelic.com ↗
One patient (25%) in the third dose cohort - who has a high risk TP53 gene mutation - had a complete remission. |
| 2016-12-06 | Mateon Therapeutics | Results Mateon Announces Presentation of OXi4503 AML Study Data at 58th Annual Meeting of American Society of Hematology oncotelic.com ↗
In total 2 of 10 (20%) patients achieved a complete remission (CR) on treatment and currently remain in CR without further treatment - one at 6 months and the other at 3 months. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Combretastatin A1 Diphosphate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00960557 ↗ |
| Known as | OXi4503 | “Combretastatin A1 Diphosphate (OXi4503)” NCT00960557 ↗ |
| Route | Intravenous | “OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.” NCT00960557 ↗ |