Drugs / PREXIGEBERSEN
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01159028 | Jun 2010 → Mar 2017 | Philadelphia-positive myelogenous leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome | Bio-Path Holdings, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02923986 | Sep 2017 → May 2020 | Philadelphia-positive myelogenous leukemia, acute myeloid leukemia, myelodysplastic syndrome | Bio-Path Holdings, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 21 trial | ||||||
| Phase 2 | NCT02781883 | May 2016 → Dec 2027 expected | acute myeloid leukemia | Bio-Path Holdings, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2025-02-13 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Provides Key Clinical Updates biopathholdings.com ↗
We are pleased to report that each of these patients remain in complete remission after two years of treatment. |
| 2024-08-21 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Reports Solid Tumor Patient Response Supporting BP1001-A’s Compelling Potential as Treatment for Advanced Solid Tumors biopathholdings.com ↗ |
| 2024-06-14 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Data from Ongoing Phase 2 Combination Study of Prexigebersen for Treatment of Acute Myeloid Leukemia at European Hematology Association Congress biopathholdings.com ↗
Encore Presentation Highlights Positive Results from Interim Analysis Demonstrating Significant Clinical Improvement and Tolerable Safety Profile for Prexigebersen Combination in High-Risk Patients |
| 2024-06-03 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Data from Ongoing Phase 2 Combination Study of Prexigebersen for Treatment of Acute Myeloid Leukemia at American Society of Clinical Oncology (ASCO) Annual Meeting biopathholdings.com ↗
Positive Results from Interim Analysis Demonstrate Significant Clinical Improvement and Tolerable Safety Profile for Prexigebersen Combination in High-Risk Patients |
| 2024-05-24 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings to Present Data at 2024 European Hematology Association Congress biopathholdings.com ↗ |
| 2024-05-23 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings to Present Data at American Society of Clinical Oncology (ASCO) Annual Meeting biopathholdings.com ↗
The data show prexigebersen continues to be well -tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy. |
| 2023-08-01 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia biopathholdings.com ↗
Prexigebersen continues to be well-tolerated and has now shown compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, which exceed outcomes with frontline therapy. |
| 2023-03-16 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Provides Clinical and Operational Update biopathholdings.com ↗ |
| 2021-12-13 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Data from Ongoing Phase 2 Study of Prexigebersen at 2021 American Society of Hematology Annual Meeting biopathholdings.com ↗
Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announces a poster highlighting the safety and preliminary efficacy data of its Phase 2 study of prexigebersen (BP1001) was presented at the 2021 American Society of Hematology (ASH) Annual Meeting, taking place from December 11-14, 2021. |
| 2021-04-05 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Successful Completion of Safety Cohort of Triple Combination of Prexigebersen, Decitabine and Venetoclax in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leukemia biopathholdings.com ↗
We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. |
| 2019-03-06 | Bio-Path Holdings, Inc. | Results Bio-Path Announces Clinical Update to Interim Analysis of Phase 2 Prexigebersen Trial in Acute Myeloid Leukemia biopathholdings.com ↗
Interim Data Update from Phase 2 Study Demonstrates Meaningful Clinical Improvement with Excellent Patient Safety Profile |
| 2018-12-03 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Interim Data from Phase 2 Study Evaluating Prexigebersen as a Treatment for Acute Myeloid Leukemia at the 60th Annual American Society of Hematology Annual Meeting biopathholdings.com ↗
Prexigebersen was safely administered to patients with untreated AML, who were considered unsuitable for standard chemotherapy. |
| 2018-04-18 | Bio-Path Holdings, Inc. | Results Pre-Clinical Data Demonstrating Promising Potential of Prexigebersen as Treatment for Solid Tumors in Gynecologic Malignancies Presented at American Association for Cancer Research Annual Meeting biopathholdings.com ↗
The data showed there was an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen/paclitaxel group compared to control. |
| 2018-04-03 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Interim Data from Phase 2 Clinical Trial of Prexigebersen in Combination with Low Dose Cytarabine (LDAC) for the Treatment of Acute Myeloid Leukemia (AML) biopathholdings.com ↗
Prexigebersen plus LDAC was well-tolerated and showed early anti-leukemic activity in nearly 50% of evaluable AML patients treated to date |
| 2018-03-29 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Publication in The Lancet Haematology biopathholdings.com ↗
Prexigebersen was well tolerated and showed early anti-leukemic activity in combination with cytarabine in relapsed or refractory hematologic malignancies |
| 2016-12-06 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Clinical Data Evaluating BP1001 as a Treatment for Chronic Myelogenous Leukemia at the 58th Annual American Society of Hematology Annual Meeting biopathholdings.com ↗
Two CML patients, who had T315I mutation, showed significant reductions in circulating blasts during treatment. |
| 2016-11-03 | Bio-Path Holdings, Inc. | Regulatory Bio-Path Announces Orphan Drug Designation in the European Union for BP1001 for the Treatment of Acute Myeloid Leukemia biopathholdings.com ↗
Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that the European Medicines Agency (EMA) granted orphan drug designation to BP1001 for the treatment of acute myeloid leukemia (AML). |
| 2016-06-06 | Bio-Path Holdings, Inc. | Results Bio -Path Holdings Reports Promising Data from Phase I and Phase II Clinical Trials of BP1001 in Blood Cancers Presented at ASCO 2016 biopathholdings.com ↗
While a small dataset, we are still very excited by these robust data showing that five of six evaluable patients demonstrated activity, especially for these refractory and resistant patients. |
| 2016-05-19 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings to Present Data at 2016 American Society of Clinical Oncology Annual Meeting biopathholdings.com ↗
Notably, there were no dose-limiting toxicities observed in the safety segment and three of the six evaluable acute myeloid leukemia (AML) patients achieved complete remission, suggesting possible AML disease inhibition. |
| 2016-05-05 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings to Present at 18th Annual TIDES: Oligonucleotide and Peptides Therapeutic Conference biopathholdings.com ↗
Clinical studies of BP1001, the lead DNAbilize™ drug candidate that targets Grb2 protein, demonstrated anti-leukemic activity and blast reduction. |
| 2016-03-03 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Completion of the Safety Segment of the Phase II Clinical Trial of BP1001 in Acute Myeloid Leukemia biopathholdings.com ↗
Results were consistent with those seen in previous cohorts, demonstrating BP1001 to be safe and well tolerated, with signs of anti-leukemia activity. |
| 2015-12-08 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings’ Data from Phase I and Safety Segment of Phase II Clinical Trials in Blood Cancers Presented at 57th American Society of Hematology (ASH) Annual Meeting biopathholdings.com ↗
Two of the three evaluable patients achieved complete remission in safety segment of the Phase II combination therapy trial of BP1001 (Liposomal Grb2 antisense) |
All press releases naming this drug 35 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PREXIGEBERSEN | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989978 ↗ |
| Known as | BP-100-1.01/L-Grb2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989978 ↗ |
| Known as | BP1001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02923986 ↗ |
| Known as | L-grb-2 antisense | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989978 ↗ |
| Known as | L-Grb2 AS | “The first goal of this clinical research study is to find the highest safe dose of BP1001, a liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide...” NCT01159028 ↗ |
| Action | Inhibit | “inhibit the cells from making Grb-2” NCT01159028 ↗ |
| Modality | Antisense oligonucleotide | “antisense oligodeoxynucleotide” NCT01159028 ↗ |
| Route | Intravenous | “administered by IV on twice weekly for 28 days” NCT01159028 ↗ |
| Target | GRB2 | “inhibit the cells from making Grb-2” NCT01159028 ↗ |