Drugs / Motixafortide
Motixafortide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | APHEXDA | — | 2023-09-08 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT06442761 | Nov 2024 → Jan 2028 expected | sickle cell disease | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06547112 | Oct 2024 → Jul 2025 | plasma cell myeloma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT05618301 | Jul 2023 → Jun 2025 | sickle cell disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT05293171 | Jun 2021 → Jun 2022 | — | BioLineRx, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02073019 | Aug 2014 → Jul 2015 | hemopoietic proliferation | BioLineRx, Ltd. | Completed | Met primary |
| Phase 1/25 trials · 1 missed | ||||||
| Phase 1/2 | NCT03154827 | Jan 2018 → Apr 2020 | acute myeloid leukemia | BioLineRx, Ltd. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03281369 | Oct 2017 → Oct 2025 | digestive system carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03193190 | Jul 2017 → Feb 2025 | pancreatic adenocarcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT02115672 | Nov 2014 → Nov 2016 | chronic myeloid leukemia | Sheba Medical Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01010880 | Oct 2008 → Jul 2010 | plasma cell myeloma | Biokine Therapeutics Ltd | Completed | No outcome recorded |
| Phase 29 trials · 1 missed | ||||||
| Phase 2 | NCT07392970 | Jul 2026 → Aug 2028 expected | acute myeloid leukemia | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04543071 | Nov 2020 → Jun 2028 expected | pancreatic adenocarcinoma | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02763384 | Dec 2016 → Feb 2022 | T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02907099 | Dec 2016 → Oct 2023 | pancreatic adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02826486 | Sep 2016 → Sep 2022 | pancreatic adenocarcinoma | BioLineRx, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02639559 | Mar 2016 → Apr 2018 | Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia +2 | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT02462252 | Oct 2015 → Nov 2020 | aplastic anemia, myelodysplastic syndrome | BioLineRx, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02502968 | Sep 2015 → Jul 2018 | acute myeloid leukemia | Dr. Petra Tschanter | Unknown | Missed primary |
| Phase 2 | NCT01838395 | Apr 2013 → Mar 2016 | acute myeloid leukemia | BioLineRx, Ltd. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06514508 | Dec 2025 → Sep 2026 overdue | plasma cell myeloma | Guangzhou Gloria Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT03246529 | Mar 2018 → Dec 2020 overdue | plasma cell myeloma | BioLineRx, Ltd. | Active not recruiting | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07101445 | Sep 2025 → Dec 2026 expected | plasma cell myeloma | Emory University | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06506461 Background | Mar 2025 → Dec 2029 expected | sickle cell disease | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 75
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Gamida Cell ltd | Results Ayrmid Reports Additional New Real-World Data on Motixafortide for Stem Cell Mobilization in Sickle Cell Disease and Beta-Thalassemia gamida-cell.com ↗
73% (11 of 15) of patients were able to collect sufficient HSC to enable progress to gene therapy manufacturing with 5 patients receiving their gene therapy and appropriately engrafted |
| 2025-12-08 | Gamida Cell ltd | Results Ayrmid Presents New Data on Motixafortide for Stem Cell Mobilization in Sickle Cell Disease gamida-cell.com ↗
Motixafortide alone and in combination with natalizumab (VLA-4 inhibitor) led to robust hematopoietic stem cell (HSC) mobilization predicting 16.9 million and 19.6 million cells/kg collected in a single apheresis session. |
| 2025-12-06 | Gamida Cell ltd | Results Ayrmid Reports Promising New Real-World Data on Motixafortide for Stem Cell Mobilization in Sickle Cell Disease gamida-cell.com ↗
90% (9 of 10) of patients were able to collect sufficient HSC to enable progress to gene therapy manufacturing |
| 2025-11-24 | BioLineRx, Ltd. | Results BioLineRx Reports Third Quarter 2025 Financial Results and Provides Corporate Update biolinerx.com ↗
The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine, demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. |
| 2025-05-30 | BioLineRx, Ltd. | Results BioLineRx Announces New Pilot Phase Data from Phase 2 Combination Trial of Motixafortide in First-Line Pancreatic Cancer (PDAC) to be Presented at ASCO 2025 Annual Meeting biolinerx.com ↗
Updated results from the pilot phase indicate that four of eleven patients remained progression free after more than one year. |
| 2024-12-17 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物宣布莫替福肽（APHEXDA®，motixafortide）获中国澳门药物监督管理局批准上市 gloriabio.com ↗
2024年9月20日，广州誉衡生物科技有限公司（简称“誉衡生物”）宣布靶向趋化因子受体4（CXC chemo-kine receptor 4，CXCR4）的全球首个多肽类药物莫替福肽（APHEXDA®，motixafortide）近日获得中国澳门特别行政区药物监督管理局正式批准上市。 |
| 2024-12-17 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 全球首款靶向CXCR4多肽药物Motixafortide（莫替福肽，APHEXDA®）落地博鳌，加速惠及中国多发性骨髓瘤患者 gloriabio.com ↗
莫替福肽成功落地博鳌乐城 |
| 2024-12-17 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物创新多肽CXCR4拮抗剂莫替福肽Motixafortide注册性三期临床研究获CDE批准 gloriabio.com ↗
2024年5月29日，广州誉衡生物科技有限公司（简称“誉衡生物”）宣布其核心产品创新细胞驱动因子受体CXCR4拮抗剂莫替福肽Motixafortide（BL-8040）近日获得国家药品监督管理局药品审评中心批准，开展一项在多发性骨髓瘤患者中联合粒细胞集落刺激因子（G-CSF）动员造血干细胞用于自体移植的三期临床研究。 |
| 2024-11-25 | BioLineRx, Ltd. | Results BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to Drive Shareholder Value biolinerx.com ↗ |
| 2024-11-05 | BioLineRx, Ltd. | Results BioLineRx Announces Oral Presentation on Data from Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease at ASH 2024 biolinerx.com ↗
Findings suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle |
| 2024-05-24 | BioLineRx, Ltd. | Results BioLineRx Announces Abstract on Pilot Study Data from Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC) at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting biolinerx.com ↗
7 of 11 patients in the pilot phase experienced a partial response, with 6 confirmed; 10 of 11 patients experienced disease control |
| 2024-02-16 | BioLineRx, Ltd. | Results BioLineRx Announces Acceptance of Two Poster Presentations on APHEXDA® (motixafortide) for CD34+ Hematopoietic Stem Cell (HSC) Mobilization in Patients with Multiple Myeloma at the 2024 Tandem Meetings of ASTCT® and CIBMTR® biolinerx.com ↗
In the GENESIS trial, post-hoc subgroup analyses based on baseline characteristics and risk factors for impaired HSC mobilization demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients. |
| 2023-09-28 | BioLineRx, Ltd. | Results BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC) biolinerx.com ↗
As of May 2023, 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. |
| 2023-09-11 | BioLineRx, Ltd. | Regulatory BioLineRx Announces FDA Approval of APHEXDA™ (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma biolinerx.com ↗ |
| 2023-04-17 | BioLineRx, Ltd. | Results BioLineRx Announces Publication in Nature Medicine of its GENESIS Phase 3 Clinical Trial Data Evaluating Motixafortide and G-CSF in Stem Cell Mobilization for Autologous Transplantation in Multiple Myeloma biolinerx.com ↗
GENESIS trial achieved statistical significance (p<0.0001) across all primary and secondary endpoints |
| 2022-11-10 | BioLineRx, Ltd. | Regulatory BioLineRx Announces U.S. FDA Acceptance of New Drug Application for APHEXDA® (motixafortide) in Stem Cell Mobilization biolinerx.com ↗
The FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of September 9, 2023. |
| 2022-11-03 | BioLineRx, Ltd. | Results BioLineRx Announces Presentations on Cost-Effectiveness of Motixafortide in Multiple Myeloma and Program for Potential Motixafortide Indication Expansion in Gene Therapy at the 64th American Society of Hematology (ASH) Annual Meeting biolinerx.com ↗
The analysis demonstrated significant net cost savings with motixafortide plus G-CSF and a greater proportion of patients achieving successful mobilization of optimal amounts of stem cells in a single apheresis day. |
| 2022-09-12 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Submission of New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization biolinerx.com ↗
today announced that the Company has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Motixafortide in stem cell mobilization (SCM) for autologous bone marrow transplantation for multiple myeloma patients. |
| 2022-03-03 | BioLineRx, Ltd. | Results BioLineRx Announces Additional Positive Results from Pharmacoeconomic Study Comparing Motixafortide + G-CSF to Plerixafor + G-CSF in Stem Cell Mobilization biolinerx.com ↗
The additional study results show that Motixafortide in combination with G-CSF, versus plerixafor in combination with G-CSF, demonstrates a statistically significant decrease in health resource utilization (HRU) during the ASCT process. |
| 2021-12-17 | BioLineRx, Ltd. | Results BioLineRx Provides Highlights from Oral Presentation Delivered at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition biolinerx.com ↗
The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma. |
| 2021-11-04 | BioLineRx, Ltd. | Results BioLineRx Announces an Oral Presentation and Three Poster Presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition biolinerx.com ↗
The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma. |
| 2021-10-13 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization biolinerx.com ↗
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent on top of granulocyte colony stimulating factor (G-CSF), versus G-CSF alone, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). |
| 2021-05-04 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Top-Line Results from GENESIS Phase 3 Trial of Motixafortide in Stem-Cell Mobilization for Autologous Bone Marrow Transplantation in Multiple Myeloma Patients biolinerx.com ↗
Study met all primary and secondary endpoints with exceptionally high level of statistical significance (p<0.0001) |
| 2021-04-15 | BioLineRx, Ltd. | Results BioLineRx Announces Presentation at 2021 American Association for Cancer Research (AACR) Annual Meeting biolinerx.com ↗
Poster includes analysis of results by liver metastases, further strengthening results reported in December 2020 of the COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer |
| 2020-12-16 | BioLineRx, Ltd. | Results BioLineRx Announces Final Results from Phase 2a COMBAT/KEYNOTE-202 Triple Combination Study of Motixafortide in Second Line Metastatic Pancreatic Cancer (PDAC) biolinerx.com ↗
The results of the study showed substantial improvement as compared to historical results across all study endpoints. |
| 2020-10-30 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization biolinerx.com ↗
today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. |
| 2020-05-27 | BioLineRx, Ltd. | Results BioLineRx Announces Publication of Data from Ongoing COMBAT/KEYNOTE-202 Clinical Trial in Nature Medicine biolinerx.com ↗
The DCR was 34.5% in the evaluable population (N=29), including nine patients (31%) with stable disease and one patient (3.4%) with partial response. |
| 2020-01-14 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Orphan Drug Designation for Motixafortide (BL-8040) for the Treatment of Pancreatic Cancer in Europe biolinerx.com ↗
European Commission (EC) has granted Orphan Drug Designation to its lead oncology candidate, Motixafortide (BL-8040), for the treatment of pancreatic cancer, based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). |
| 2019-12-13 | BioLineRx, Ltd. | Results BioLineRx Announces Updated Phase 2a Data From Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Patients With Second-line Metastatic Pancreatic Cancer biolinerx.com ↗
Combination of BL-8040, KEYTRUDA® and chemotherapy demonstrates a 32% overall response rate and a 77% disease control rate out of 22 currently evaluable patients |
| 2019-12-05 | BioLineRx, Ltd. | Results BioLineRx Announces Preliminary Phase 2a Data from Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Second Line Patients With Metastatic Pancreatic Cancer biolinerx.com ↗
Combination of BL-8040, KEYTRUDA® and chemotherapy showed high level of disease control, including 4 partial responders and 8 patients with stable disease out of 15 evaluable patients |
| 2019-11-05 | BioLineRx, Ltd. | Results BioLineRx Presents Preclinical Data From Triple Combination of BL-8040, Anti PD-1 and Chemotherapy Demonstrating Significant Reduction in Pancreatic Tumor Growth and Favorable Changes in Tumor Microenvironment biolinerx.com ↗
Combination of BL-8040, anti PD-1 and chemotherapy significantly reduced pancreatic tumor growth and changed the balance between CD4+/FOXP3+ cells and CD8+ cells in the tumor |
| 2019-11-05 | BioLineRx, Ltd. | Results BioLineRx Announces BL-8040 in Combination With KEYTRUDA Shows Clinical Activity in Heavily Pretreated Metastatic Pancreatic Cancer Patients biolinerx.com ↗
The data demonstrated that the dual combination shows clinical activity in heavily pretreated patients. |
| 2019-03-27 | BioLineRx, Ltd. | Results BioLineRx Announces Successful Engraftment Data From Phase 3 GENESIS Trial for BL-8040 in Multiple Myeloma Patients biolinerx.com ↗
Furthermore, engraftment of the cells in all evaluable patients was successful. |
| 2019-02-04 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer biolinerx.com ↗
announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of pancreatic cancer. |
| 2018-10-20 | BioLineRx, Ltd. | Results BioLineRx Discloses Additional Data from Phase 2a COMBAT/KEYNOTE-202 Study in Pancreatic Cancer at ESMO 2018 Congress biolinerx.com ↗
The results presented today at a poster discussion session at the European Society for Medical Oncology 2018 Congress, in Munich, Germany, demonstrate that BL-8040 significantly improves T-cell infiltration into the tumor and reduces immunosuppression in the tumor microenvironment. |
| 2018-10-19 | BioLineRx, Ltd. | Results BioLineRx Presents Top-line Results from Phase 2a COMBAT/KEYNOTE-202 Study in Pancreatic Cancer at ESMO 2018 Congress biolinerx.com ↗
The results show encouraging disease control and extended overall survival, particularly in patients undergoing second-line treatment. |
| 2018-08-07 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Results of Lead-in Period for Phase 3 GENESIS Trial in Stem-Cell Mobilization biolinerx.com ↗
Results of the first 11 patients show that BL-8040 in combination with standard G-CSF treatment is safe and tolerable. |
| 2018-06-18 | BioLineRx, Ltd. | Results BioLineRx Presents New Overall Survival Data From Phase 2a Study for BL-8040 in r/r AML Patients biolinerx.com ↗
In addition, an important new finding shows a statistically significant correlation between patient response and the mobilization of AML blasts. |
| 2018-05-17 | BioLineRx, Ltd. | Results BioLineRx Reports Results of Phase 2 Study for BL-8040 Monotherapy in Stem Cell Mobilization for Allogeneic Bone Marrow Transplantation biolinerx.com ↗
Single-agent treatment with BL-8040, a novel, high-affinity CXCR4 antagonist with rapid HSPC mobilizing kinetics, showed similar efficacy in only one administration. |
| 2018-05-17 | BioLineRx, Ltd. | Results BioLineRx to Present Overall Survival Data at EHA from Phase 2a Study of BL-8040 in r/r AML Patients biolinerx.com ↗
The response rate for all dosing levels was 29% and median overall survival was 9.1 months, compared with historical data on overall survival of 6.1 months for HiDAC alone. |
| 2018-01-23 | BioLineRx, Ltd. | Results BioLineRx Presents Preclinical Data at ASCO-SITC Showing BL-8040 Prolongs Survival by Mediating Tumor Infiltration of Antigen-Specific T-cells biolinerx.com ↗
The results of the study show that combining BL-8040 with the cancer vaccine leads to a significantly enhanced anti-tumor immune response, which attenuates tumor growth and prolongs mouse survival better than either agent administered alone. |
| 2018-01-17 | BioLineRx, Ltd. | Results BioLineRx Announces Partial Monotherapy Results from Phase 2a COMBAT Study in Pancreatic Cancer biolinerx.com ↗
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today partial results from the monotherapy portion of BL-8040's Phase 2a COMBAT study showing that BL-8040 increases infiltration of T cells into the tumor in patients with metastatic pancreatic cancer. |
| 2017-12-04 | BioLineRx, Ltd. | Results BioLineRx Reports Overall Survival Results From Long-term Follow-up of Phase 2a Trial in r/r AML biolinerx.com ↗
The results demonstrate that the combination of BL-8040 with high-dose Ara-C (HiDAC) in this difficult-to-treat patient population significantly improved overall survival, compared with historical data of HiDAC monotherapy. |
| 2017-11-02 | BioLineRx, Ltd. | Results BioLineRx Announces Oral Presentation at ASH of Data Supporting BL-8040 as Robust Mobilizer of Hematopoietic Stem Cells (HSC) Associated with Long-Term Engraftment biolinerx.com ↗
The study further showed that BL-8040-mobilized HSCs can successfully engraft the bone marrow and spleen of immunodeficient mice. |
| 2017-08-21 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission of Phase 3 Registrational Study for BL-8040 in Stem Cell Mobilization biolinerx.com ↗
announced today the filing of regulatory submissions required to commence a randomized, controlled Phase 3 registrational trial of BL-8040 |
| 2017-06-01 | BioLineRx, Ltd. | Regulatory BioLineRx Reports Regulatory Submissions of Three Phase 1b Trials for BL-8040 in Combination With Atezolizumab for Solid Tumors biolinerx.com ↗ |
| 2017-05-22 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission for Phase 1b Trial of BL-8040 in Combination with Atezolizumab in AML biolinerx.com ↗ |
| 2017-03-20 | BioLineRx, Ltd. | Results BioLineRx Provides Update on Phase 2 Open-Label Study for BL-8040 as Novel Stem Cell Mobilization Treatment biolinerx.com ↗
Interim results show that a single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of G-CSF, the current standard of care. |
| 2016-12-05 | BioLineRx, Ltd. | Results BioLineRx Presents Positive Phase 2a AML Study and Mechanism-of-Action Data for BL-8040 Oncology Platform at ASH 2016 biolinerx.com ↗
BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, presents positive Phase 2a correlative data, as well as detailed mechanism-of-action data, for BL-8040, the Company's leading oncology platform at the ongoing 58th American Society of Hematology (ASH) Annual Meeting and Exhibition in San Diego, California. |
| 2016-11-03 | BioLineRx, Ltd. | Results BioLineRx Discloses Positive Correlative Data from Phase 2a AML Study and Mechanism-of-Action Data for BL-8040 Oncology Platform at ASH 2016 biolinerx.com ↗
BioLineRx reports the final correlative results from its Phase 2a trial in acute myeloid leukemia (AML). |
| 2016-09-08 | BioLineRx, Ltd. | Results BioLineRx Presents Final Results from Phase 2a Trial for Relapsed/Refractory AML at SOHO Conference biolinerx.com ↗
Results show that treatment with BL-8040 in combination with Ara-C was safe and well tolerated at all doses tested up to and including the highest dose level of 2.0 mg/kg. |
| 2016-06-28 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submissions for Phase 2a Trial of BL-8040 in Combination with KEYTRUDA® (pembrolizumab) for Treatment of Pancreatic Cancer biolinerx.com ↗
announced today the filing of regulatory submissions required to commence a Phase 2a trial for BL-8040 in combination with KEYTRUDA® (pembrolizumab) for the treatment of patients with pancreatic cancer. |
| 2016-04-19 | BioLineRx, Ltd. | Results BioLineRx Announces Presentation of Detailed Mechanism of Action Data for Lead Oncology Platform at AACR 2016 biolinerx.com ↗
The studies presented showed that BL-8040 increases the suppression of these three target proteins through miR-15a/16-1, thereby increasing tumor cell death. |
| 2016-03-29 | BioLineRx, Ltd. | Results BioLineRx Reports Successful Top-Line Results in Phase 2 Trial for AML biolinerx.com ↗
BioLineRx (NASDAQ/TASE: BLRX) announced today positive top-line results from BL-8040's Phase 2 clinical trial in relapsed or refractory acute myeloid leukemia (r/r AML). |
| 2015-12-14 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040 as Novel Stem Cell Mobilization Treatment biolinerx.com ↗
The study submission was made following a meeting with the FDA in October 2015 to discuss the BL-8040 stem cell mobilization development program. |
| 2015-11-05 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Clinical Results from First Part of Phase 2 Trial in r/r AML biolinerx.com ↗
Results showed that BL-8040, as a single agent and in combination with Cytarabine (Ara-C), was safe and well tolerated at all doses tested up to and including the highest dose level of 1.5 mg/kg, with no major adverse events. |
| 2015-09-10 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission for Phase 2 Trial of BL-8040 as Novel Treatment for Hypoplastic Myelodysplastic Syndrome and Aplastic Anemia biolinerx.com ↗ |
| 2015-06-15 | BioLineRx, Ltd. | Results BioLineRx Presents Positive Safety and Efficacy Results for Novel Stem-Cell Mobilization Treatment at European Hematology Association Conference biolinerx.com ↗
Treatment with BL-8040 as a single agent was found safe and well tolerated at all doses, and resulted in efficient stem-cell mobilization and collection in all study participants. |
| 2015-05-04 | BioLineRx, Ltd. | Results BioLineRx Initiates Expansion Stage of Phase 2 Clinical Trial for Novel Treatment for Acute Myeloid Leukemia biolinerx.com ↗
Results of the completed dose escalation stage, in which 22 patients participated, showed that all BL-8040 tested doses, up to 1.5 mg/kg, were found to be safe and well tolerated when administered in combination with Ara-C (Cytarabine). |
| 2015-03-25 | BioLineRx, Ltd. | Results BioLineRx Reports Successful Top-Line Safety and Efficacy Results for Novel Stem Cell Mobilization Treatment biolinerx.com ↗
All safety and efficacy endpoints were met, showing that treatment with BL-8040 as a single agent was safe and well tolerated at all doses and resulted in efficient stem cell mobilization and collection in all study participants. |
| 2015-03-02 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission for Phase 2b Trial for Novel AML Consolidation Treatment biolinerx.com ↗
Regulatory submissions with BfArM, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) and the relevant ethics committees have been made. |
| 2014-12-08 | BioLineRx, Ltd. | Results BioLineRx Reports Positive Data from Ongoing Phase 2a Study for AML Treatment at ASH Conference biolinerx.com ↗
Additional results show that after only two days of BL-8040 monotherapy, there was a median decrease of approximately 70% in the amount of AML cells in the bone marrow, while the levels of normal progenitor cells remained stable. |
| 2014-11-03 | BioLineRx, Ltd. | Regulatory BioLineRx Files Protocol Amendment to Phase 2 Study for AML Treatment based on Encouraging Efficacy and Strong Safety Profile biolinerx.com ↗
the Company has filed with the U.S. Food and Drug Administration (FDA) an amendment to the study protocol to test additional cohorts at higher doses in the current dose-escalation stage of the trial. |
| 2014-09-17 | BioLineRx, Ltd. | Results BioLineRx Presents Positive Preclinical Results in Treatment for AML Patients with FLT3 Mutations biolinerx.com ↗
The data presented during the conference show that BL-8040 rapidly and efficiently induces cell death of AML cells both in-vitro and in-vivo. |
| 2014-06-16 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Approval to Commence Phase 1 Trial for Novel Stem Cell Mobilization Treatment biolinerx.com ↗ |
| 2014-04-10 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Investigator-Initiated Study for Novel Chronic Myeloid Leukemia Treatment biolinerx.com ↗
BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, has received final regulatory approval to evaluate BioLineRx’s BL-8040 as a treatment for chronic myeloid leukemia (CML) in a Phase 1/2 clinical study. |
| 2014-02-12 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Preclinical Results for Novel Treatment for Chronic Myeloid Leukemia biolinerx.com ↗
BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today positive pre-clinical results for BL-8040 in a third indication - as a treatment for chronic myeloid leukemia. |
| 2014-01-23 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Orphan Drug Designation for Novel Stem Cell Mobilization Treatment biolinerx.com ↗
BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has received notice from the U.S. Food & Drug Administration (FDA) confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the Orphan Drug Designation previously granted to BL-8040 as a treatment for Acute Myeloid Leukemia (AML). |
| 2014-01-13 | BioLineRx, Ltd. | Regulatory BioLineRx Announces Regulatory Submission for Novel Stem Cell Mobilization Treatment biolinerx.com ↗
announced today that it has filed the necessary regulatory submissions to commence a Phase 1 trial for BL-8040, a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation. |
| 2013-12-16 | BioLineRx, Ltd. | Results BioLineRx Announces Promising Initial Phase 2 Results of Acute Myeloid Leukemia Treatment biolinerx.com ↗
In addition, signs of robust apoptosis (cell death) of cancer cells were observed following administration of the higher doses tested to date. |
| 2013-12-10 | BioLineRx, Ltd. | Results BioLineRx Presents Positive Preclinical Results of Acute Myeloid Leukemia Treatment at ASH Conference biolinerx.com ↗
The data presented in the conference show that BL-8040 directly inhibits AML cell growth and induces cell death, both in cell cultures and in mice engrafted with human AML cells. |
| 2013-11-19 | BioLineRx, Ltd. | Results BioLineRx Reports Publication in Peer Review Journal of Positive Phase 1/2 Results in Stem Cell Mobilization for Multiple Myeloma biolinerx.com ↗
Results published in Clinical Cancer Research |
| 2013-09-09 | BioLineRx, Ltd. | Regulatory BioLineRx's BL-8040 Receives Orphan Drug Designation for Treatment of AML biolinerx.com ↗
BioLineRx (NASDAQ: BLRX; TASE: BLRX), a biopharmaceutical development company, announced today that the U.S. Food & Drug Administration (FDA) has granted an Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of acute myeloid leukemia (AML). |
| 2013-08-05 | BioLineRx, Ltd. | Results BioLineRx Announces Publication of Positive Pre-Clinical Results for BL-8040 in Treatment of Thrombocytopenia biolinerx.com ↗
The results show that repeated administration of BL-8040 significantly increased the number of megakaryocytes (cells that produce platelets) within the bone marrow; this was associated with increased production and increased levels of platelets in the blood circulation, in both the healthy and chemotherapy induced-thrombocytopenic mice. |
| 2013-04-10 | BioLineRx, Ltd. | Regulatory BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatment of Leukemia biolinerx.com ↗
BioLineRx (NASDAQ:BLRX)(TASE:BLRX), a biopharmaceutical development company, announced today that it has received all necessary regulatory approvals in the US to commence a Phase IIa trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML). |
All press releases naming this drug 113 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 113 releases opens the full record — a long page | ||
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Motixafortide | “the CXCR4 antagonist BL-8040 (motixafortide) with pembrolizumab and chemotherapy in metastatic PDAC (NCT02826486).” PMID 32451495 ↗ May 20209“Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects” NCT05293171 ↗ |
| Known as | 4F-benzoyl-TN14003 | “BKT140 (4F-benzoyl-TN14003) is a highly selective and unique CXCR4 antagonist.” NCT01010880 ↗ |
| Known as | BKT-140 | “BKT-140 drug substance is a highly selective CXCR4 antagonist.” NCT01010880 ↗ |
| Known as | BL-8040 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01838395 ↗ |
| Known as | Motixafortida | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095030 ↗ |
| Known as | T140 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095030 ↗ |
| Known as | TF 14016 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095030 ↗ |
| Action | Inhibit | “BKT140 (4F-benzoyl-TN14003) is a highly selective and unique CXCR4 antagonist.” NCT01010880 ↗ |
| Modality | Peptide | “Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended in vivo activity.” PMID 37069359 ↗ Apr 2023 |
| Route | Subcutaneous | “BKT140 will be injected S.C once at dose of 0.03, 0.1, 0.3, 0.9 mg/kg” NCT01010880 ↗ |
| Target | CXCR4 | “BKT140 (4F-benzoyl-TN14003) is a highly selective and unique CXCR4 antagonist.” NCT01010880 ↗ |