Drugs / OXi4503
OXi4503
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01085656 | Feb 2011 → Jan 2016 | acute myeloid leukemia, myelodysplastic syndrome | University of Florida | Terminated | No outcome recorded |
| Phase 1 | NCT00977210 | Jul 2005 → Sep 2010 | cancer | Mateon Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02576301 | Oct 2015 → Oct 2019 | acute myeloid leukemia, myelodysplastic syndrome | Mateon Therapeutics | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-09-16 | Mateon Therapeutics | Regulatory FDA Granted Pediatric Disease Designation for OXi-4503 oncotelic.com ↗
We are excited about this Rare Pediatric Disease designation for AML. |
| 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 ↗
Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, today announced that the U.S. 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. |
| 2017-10-30 | Mateon Therapeutics | Results Mateon Therapeutics Announces Updated Data from Fifth Cohort of Phase 1b Study of OXi4503 in Acute Myeloid Leukemia oncotelic.com ↗
The other patient continued to receive treatment with an additional two cycles of OXi4503 and remains in complete remission with a cytogenetic complete response. |
| 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. |
| 2017-06-12 | Mateon Therapeutics | Results Mateon Therapeutics Provides Update on its Clinical Trial Programs and Milestones oncotelic.com ↗
Three complete remissions were observed in the first three cohorts (19% overall in the clinical trial to date), each of which occurred after two cycles of treatment, and two complete remissions remain on-going at 12+ and 3+ months. |
| 2017-06-07 | Mateon Therapeutics | Regulatory Mateon Therapeutics Receives FDA Fast Track Designation for OXi4503 in Patients with Acute Myeloid Leukemia oncotelic.com ↗
Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's product candidate OXi4503 for the treatment of acute myeloid leukemia (AML). |
| 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 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OXi4503 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02576301 ↗ |
| Known as | CA1P | “Preclinical studies show that OXi4503 (combretastatin A1 diphosphate, CA1P) is more potent than other clinically evaluated vascular-disrupting agents.” PMID 22235096 ↗ Jan 2012 |
| Known as | combretastatin A1 diphosphate | “Preclinical studies show that OXi4503 (combretastatin A1 diphosphate, CA1P) is more potent than other clinically evaluated vascular-disrupting agents.” PMID 22235096 ↗ Jan 2012 |
| Modality | Other / unclassified | “OXi4503 is a novel microtubule targeting agent” NCT01085656 ↗ |
| Route | Intravenous | “given as an intravenous infusion” NCT00977210 ↗ |