Drugs / APTO-253
APTO-253
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | inherited hematologic cancer-predisposing syndrome | 2015-11-20 | “In June, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on APTO-253 following the company’s actions” aptose.com ↗ “placed the Phase Ib clinical trial of APTO-253 in patients with hematologic cancers on clinical hold.” aptose.com ↗ “APTO-253, including a clinical hold placed by the U.S. Food & Drug Administration.” aptose.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02267863 | Oct 2014 → Sep 2021 | acute myeloid leukemia, myelodysplastic syndrome | Aptose Biosciences Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01281592 | Jan 2011 → Jul 2013 | — | Aptose Biosciences Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2021-06-11 | Aptose Biosciences Inc. | Results Aptose Presents Highlights from EHA During Corporate Update Event aptose.com ↗ |
| 2019-12-07 | Aptose Biosciences Inc. | Results Aptose Presents Highlights From Corporate Event At ASH aptose.com ↗
Aptose Management and KOL’s Discuss Early Clinical Observations with CG-806 and APTO-253 |
| 2019-08-06 | Aptose Biosciences Inc. | Results Aptose Reports Results for the Second Quarter Ended June 30, 2019 aptose.com ↗
APTO-253 Inhibits MYC in AML and MDS Patients in Phase 1 Clinical Trial |
| 2019-07-16 | Aptose Biosciences Inc. | Results Aptose Doses First CLL Patient in Phase 1 Study of CG-806 and Doses Third Cohort in Phase 1 Study of APTO-253 aptose.com ↗
Initial data from the first two cohorts demonstrate MYC inhibition in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). |
| 2019-04-01 | Aptose Biosciences Inc. | Results Aptose Presents New Preclinical Data on CG-806 and APTO-253 at the 2019 AACR Annual Meeting aptose.com ↗
MYC Inhibitor APTO-253 Potently Kills Hematologic Cell Lines; Mechanism of Action Further Defined |
| 2018-06-29 | Aptose Biosciences Inc. | Regulatory FDA Lifts Clinical Hold so MYC Inhibitor APTO-253 Can Return to Phase 1b Trial In Patients With Hematologic Cancers aptose.com ↗ |
| 2018-06-04 | Aptose Biosciences Inc. | Results Aptose Announces Two Publications of Preclinical Data Elucidating the Anticancer Mechanism of Action of APTO-253 aptose.com ↗ |
| 2018-04-17 | Aptose Biosciences Inc. | Results Aptose Presents Preclinical Data on APTO-253 at 2018 AACR Annual Meeting aptose.com ↗
The data, demonstrating heightened sensitivity of BRCA1 or BRCA2 mutated cancer cells to APTO-253, were presented in a poster Tuesday, April 17 at the 2018 American Association for Cancer Research (AACR) Annual Meeting being held April 14-18, in Chicago, IL. |
| 2016-10-13 | Aptose Biosciences Inc. | Regulatory Aptose Provides Update on FDA Clinical Hold of APTO-253 aptose.com ↗
The FDA response to Aptose focused exclusively on the request to provide the FDA with complete Chemistry, Manufacturing and Control (CMC) information on the final GMP drug substance and drug product intended for the clinic. |
| 2016-09-12 | Aptose Biosciences Inc. | Regulatory Aptose Submits Formal Response to Clinical Hold for APTO-253 aptose.com ↗ |
| 2015-11-20 | Aptose Biosciences Inc. | Regulatory Aptose Voluntarily Suspends Clinical Dosing of APTO-253 to Review Drug Manufacturing Processes and Procedures aptose.com ↗
This hold is intended to ensure patient safety on the trial and to ensure manufacturing and dosing procedures are consistent with the appropriate documented quality standards. |
| 2015-11-05 | Aptose Biosciences Inc. | Results Beat AML & Aptose Biosciences Present Data for APTO-253 at the 57th American Society of Hematology (ASH) Annual Meeting aptose.com ↗
Moreover, APTO-253 demonstrated enhanced killing ability of AML cells in patient samples when combined with either the BET inhibitor JQ1 or with the FLT3 inhibitor quizartinib. |
| 2015-06-02 | Aptose Biosciences Inc. | Regulatory Aptose Biosciences Granted Orphan Drug Designation by the U.S. FDA for APTO-253 in Acute Myeloid Leukemia aptose.com ↗ |
| 2014-12-09 | Aptose Biosciences Inc. | Results Aptose Biosciences Presents APTO-253 Preclinical Data at 56th American Society of Hematology Annual Meeting aptose.com ↗
In the poster, Aptose researchers reported the first set of in vivo murine xenograft study data for APTO-253 in hematologic malignancies, demonstrating antitumor activity as a single agent, and in combination with the hypomethylating agent, azacitadine. |
All press releases naming this drug 23 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APTO-253 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02267863 ↗ |
| Known as | LOR-253 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01281592 ↗ |
| Known as | LOR-253(FORMER CODE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297261 ↗ |
| Known as | Lt-253 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297261 ↗ |
| Known as | LT-253(FORMER CODE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297261 ↗ |
| Modality | Small molecule | — CHEMBL4297261 ↗ |