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2 Diseases |  |
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40 Trials |  |
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- | Revlimid (lenalidomide) / Celgene, sotatercept (ACE-011) / Celgene, Acceleron, luspatercept (ACE-536) / Celgene, Acceleron
Review, Journal: Transforming growth factor (TGF)-β pathway as a therapeutic target in lower risk myelodysplastic syndromes. (Pubmed Central) - Sep 8, 2019
Additional potential targets within the TGF-β pathway have also been identified in preclinical experiments and may provide further therapeutic options. Finally, combining different TGF-β pathway inhibitors or using them in combination with ESAs or the immunomodulator lenalidomide might have synergistic effects as well.
- | luspatercept (ACE-536) / Celgene, Acceleron
Journal: Managing anaemia in bone marrow failure syndromes. (Pubmed Central) - Sep 6, 2019
Majority of these patients are not suitable for definite treatment options such as bone marrow transplantation. The aim of treatment remains improving the quality of life and newer therapeutic options may offer better and more sustained response.
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment open: LTFU: A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials (clinicaltrials.gov) - Aug 29, 2019
P3b, N=665, Recruiting, Sponsor: Celgene
The aim of treatment remains improving the quality of life and newer therapeutic options may offer better and more sustained response. Not yet recruiting --> Recruiting
- || luspatercept (ACE-536) / Celgene, Acceleron
Will Dr Maria Cappellini be talking about Luspatercept which hopefully will be approved late this year in US? (Twitter) - Aug 27, 2019
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
New P3 trial: LTFU: A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials (clinicaltrials.gov) - Aug 20, 2019
P3b, N=665, Not yet recruiting, Sponsor: Celgene
- ||| luspatercept (ACE-536) / Celgene, Acceleron
Clinical, FDA event: @DavidSteensma Any news on Luspatercept BLA FDA decision? Got a few pts waiting for approval.. (Twitter) - Jul 9, 2019
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion date, Trial primary completion date: BEYOND: A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (?)-Thalassemia (clinicaltrials.gov) - Jun 12, 2019
P2, N=150, Recruiting, Sponsor: Celgene
Not yet recruiting --> Recruiting Trial completion date: Mar 2020 --> Aug 2020 | Trial primary completion date: Oct 2019 --> Jun 2020
- || luspatercept (ACE-536) / Celgene, Acceleron
European regulatory: $CELG $XLRN Luspatercept EU Marketing Authorization Application also validated (Twitter) - Jun 4, 2019
- |||| imetelstat (JNJ-63935937) / Geron, luspatercept (ACE-536) / Celgene, Acceleron
Video: #Imetelstat $GERN: You can view the video of the presentation, along with the slides and transcript: Click on the "View Only, No Credit" button. Thanks to @MediComOncology. The Future of #MDS Treatment: #Imetelstat and #Luspatercept | @MikkaelSekeres @DavidSteensma | $GERN (Twitter) - May 29, 2019
- ||| imetelstat (JNJ-63935937) / Geron, luspatercept (ACE-536) / Celgene, Acceleron
From @MediComOncology: The Future of #MDS Treatment: #Imetelstat and #Luspatercept | @MikkaelSekeres @DavidSteensma | $GERN (Twitter) - May 29, 2019
- | Campath (alemtuzumab) / Sanofi, Soliris (eculizumab) / Alexion Pharma, Rituxan (rituximab) / Roche, Biogen
Journal: Current and emerging treatment options for autoimmune hemolytic anemia. (Pubmed Central) - May 22, 2019
The latter may give hints for targeted therapies (either B or T cell directed) and for new immunomodulatory drugs. Future studies on the genomic landscape in AIHA will further help in designing the best choice, sequence and/or combination of targeted therapies.
- | sotatercept (ACE-011) / Celgene, Acceleron, luspatercept (ACE-536) / Celgene, Acceleron
Journal: Combined immuno-purification and detection of recombinant EPOs and ActRII-Fc proteins by isoelectric focusing (IEF) for application in doping control. (Pubmed Central) - May 15, 2019
With these changes, distinctive profiles for all the ESAs were obtained by IEF. Therefore IEF could be used as a screening method to detect a wide spectrum of prohibited ESAs in blood samples prior to specific confirmation for the identified rEPO or ActRII-Fc.
- ||| luspatercept (ACE-536) / Celgene, Acceleron
While I'm an optimist by nature, the current status quo for #MDS is dire. No drug approvals since 2006 (luspatercept will help but is a single, not a homer), median survival <3 years. This talk was my idiosyncratic take on how we got to where we are and how we can move forward. (Twitter) - May 11, 2019
- || luspatercept (ACE-536) / Celgene, Acceleron
European Approval Sought for Luspatercept for Anemias https://t.co/X0Aj0W2NB8 (Twitter) - May 5, 2019
- || luspatercept (ACE-536) / Celgene, Acceleron
European Approval Sought for Luspatercept for Anemias https://t.co/X0Aj0W2NB8 (Twitter) - Apr 26, 2019
- | sotatercept (ACE-011) / Celgene, Acceleron, luspatercept (ACE-536) / Celgene, Acceleron
Journal: Activin receptor ligand traps in chronic kidney disease. (Pubmed Central) - Apr 19, 2019
Their long-term efficacy and safety still needs to be proven, particularly with respect to immunogenicity. Antifibrotic effects may be worthy to be investigated in humans.
- || luspatercept (ACE-536) / Celgene, Acceleron
.@Celgene files potential blockbuster #luspatercept as @bmsnews merger looms https://t.co/mYr0sWO3xy #pharmanews (Twitter) - Apr 8, 2019
- ||| imetelstat (JNJ-63935937) / Geron, luspatercept (ACE-536) / Celgene, Acceleron
I do think MDS - the marrow failure portion - has been neglected, and that’s where drugs like luspatercept, imetelstat may have a role. But once blasts start to accumulate, biology is more AML-like & it is arbitrary to exclude someone with 17% blasts from a trial but include 21%. (Twitter) - Apr 7, 2019
- ||| luspatercept (ACE-536) / Celgene, Acceleron
Have to disagree with @lane_andy on this. For too long MDS has been second thought to AML trials but many biological differences. I would suggest there is more need for MDS-specific large-scale trials & need to rationally target subsets (like recent luspatercept MEDALIST trial) (Twitter) - Apr 6, 2019
- || luspatercept (ACE-536) / Celgene, Acceleron
Luspatercept? No bueno? 🤔 (Twitter) - Apr 6, 2019
- ||| luspatercept (ACE-536) / Celgene, Acceleron
FDA event: FDA Approval Sought for Luspatercept for Anemias https://t.co/hCFDZvAJYH (Twitter) - Apr 5, 2019
- |||| luspatercept (ACE-536) / Celgene, Acceleron
BLA: Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA https://t.co/PeQjvhjBHc (Twitter) - Apr 5, 2019
- || luspatercept (ACE-536) / Celgene, Acceleron
$CELG & $XLRN Announce Submission of Luspatercept BLA. BLA submission includes both myelodysplastic syndromes and beta-thalassemia indications EMA MAA for both indications planned for Q2'19 (Twitter) - Apr 5, 2019
- | sotatercept (ACE-011) / Celgene, Acceleron, luspatercept (ACE-536) / Celgene, Acceleron
Clinical, Journal: Updated protocols for the detection of Sotatercept and Luspatercept in human serum. (Pubmed Central) - Apr 3, 2019
They also omit the secondary antibody incubation step by usage of biotinylated primary antibodies, which can be directly incubated with streptavidin-HRP. Thus, the new protocols are faster, simpler, and cheaper and offer comparable sensitivities.
- | sotatercept (ACE-011) / Celgene, Acceleron, luspatercept (ACE-536) / Celgene, Acceleron
Journal: Combined detection of the ActRII-Fc fusion proteins Sotatercept (ActRIIA-Fc) and Luspatercept (modified ActRIIB-Fc) in serum by means of immunoaffinity purification, tryptic digestion, and LC-MS/MS. (Pubmed Central) - Apr 3, 2019
The assay was optimized, comprehensively characterized, and found to be fit-for-purpose for an application to sports drug testing. It complements existing tests for ActRII-Fc fusion proteins and expands the range of available detection methods for novel protein therapeutics.
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
New P2 trial: An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion (clinicaltrials.gov) - Apr 3, 2019
P2, N=20, Not yet recruiting, Sponsor: Celgene
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment open: COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Na (clinicaltrials.gov) - Oct 31, 2018
P3, N=300, Recruiting, Sponsor: Celgene
It complements existing tests for ActRII-Fc fusion proteins and expands the range of available detection methods for novel protein therapeutics. Not yet recruiting --> Recruiting
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion, Trial completion date, Trial primary completion date: PACS-MDS: Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001) (clinicaltrials.gov) - Oct 19, 2018
P2, N=116, Completed, Sponsor: Acceleron Pharma, Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Jun 2019 --> Sep 2018 | Trial primary completion date: Dec 2018 --> Aug 2018
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment closed, Enrollment change: Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003) (clinicaltrials.gov) - Oct 19, 2018
P2, N=75, Active, not recruiting, Sponsor: Acceleron Pharma, Inc.
Recruiting --> Completed | Trial completion date: Jun 2019 --> Sep 2018 | Trial primary completion date: Dec 2018 --> Aug 2018 Recruiting --> Active, not recruiting | N=128 --> 75
- | Venclexta (venetoclax) / Roche, AbbVie, Reblozyl (luspatercept-aamt) / Acceleron, BMS
Journal, IO biomarker: Recent advances in the cellular and molecular understanding of myelodysplastic syndromes: implications for new therapeutic approaches. (Pubmed Central) - Sep 28, 2018
Agents in clinical trials for subsets of MDS include luspatercept, antibodies targeting CD33, isocitrate dehydrogenase inhibitors, deacetylase inhibitors, venetoclax, and immunotherapies designed to overcome immune checkpoint inhibition. These biologically based therapeutics, as well as the encouraging precedent of 7 new approvals by the US Food and Drug Administration in 2017 for the treatment of acute leukemia, offer the prospect that 10 more years will not elapse before another new therapy is approved for MDS.
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
New P3 trial: COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Na (clinicaltrials.gov) - Sep 24, 2018
P3, N=350, Not yet recruiting, Sponsor: Celgene
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion date, Trial primary completion date: AZA-MDS-006: Connect (clinicaltrials.gov) - Jun 6, 2018
P=N/A, N=1500, Recruiting, Sponsor: Celgene
These biologically based therapeutics, as well as the encouraging precedent of 7 new approvals by the US Food and Drug Administration in 2017 for the treatment of acute leukemia, offer the prospect that 10 more years will not elapse before another new therapy is approved for MDS. Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Dec 2018 --> Dec 2020
- | Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Phase classification: BEYOND: A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (?)-Thalassemia (clinicaltrials.gov) - Apr 26, 2018
P2, N=150, Recruiting, Sponsor: Celgene
Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Dec 2018 --> Dec 2020 Phase classification: P3 --> P2
- |||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment open, Phase classification, Trial primary completion date: BEYOND: A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (?)-Thalassemia (clinicaltrials.gov) - Mar 26, 2018
P3, N=150, Recruiting, Sponsor: Celgene
Phase classification: P3 --> P2 Not yet recruiting --> Recruiting | Phase classification: P2 --> P3 | Trial primary completion date: Feb 2020 --> Oct 2019
- |||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion date, Trial primary completion date: MEDALIST: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (clinicaltrials.gov) - Mar 5, 2018
P3, N=229, Active, not recruiting, Sponsor: Celgene
Not yet recruiting --> Recruiting | Phase classification: P2 --> P3 | Trial primary completion date: Feb 2020 --> Oct 2019 Trial completion date: Jun 2019 --> Nov 2020 | Trial primary completion date: Jun 2019 --> Jun 2018
- ||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
New P2 trial: BEYOND: A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (?)-Thalassemia (clinicaltrials.gov) - Nov 17, 2017
P2, N=150, Not yet recruiting, Sponsor: Celgene
- |||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: BELIEVE: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (?) Thalassemia (clinicaltrials.gov) - Nov 14, 2017
P3, N=335, Active, not recruiting, Sponsor: Celgene
Trial completion date: Jun 2019 --> Nov 2020 | Trial primary completion date: Jun 2019 --> Jun 2018 Trial primary completion date: Sep 2018 --> Nov 2017
- |||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment open: ACE-536-MF-001: A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence (clinicaltrials.gov) - Nov 6, 2017
P2, N=70, Recruiting, Sponsor: Celgene
Trial primary completion date: Sep 2018 --> Nov 2017 Not yet recruiting --> Recruiting
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: PACS-MDS: Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001) (clinicaltrials.gov) - Oct 17, 2017
P2, N=128, Recruiting, Sponsor: Acceleron Pharma, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Apr 2017 --> Dec 2018
- ||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment change: BELIEVE: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (?) Thalassemia (clinicaltrials.gov) - Jul 24, 2017
P3, N=335, Active, not recruiting, Sponsor: Celgene
Trial primary completion date: Apr 2017 --> Dec 2018 N=447 --> 335
- ||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment closed: MEDALIST: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (clinicaltrials.gov) - Jul 2, 2017
P3, N=210, Active, not recruiting, Sponsor: Celgene
N=447 --> 335 Recruiting --> Active, not recruiting
- ||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
New P2 trial: ACE-536-MF-001: A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence (clinicaltrials.gov) - Jun 20, 2017
P2, N=70, Not yet recruiting, Sponsor: Celgene
- ||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment closed, Enrollment change: BELIEVE: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (?) Thalassemia (clinicaltrials.gov) - May 31, 2017
P3, N=447, Active, not recruiting, Sponsor: Celgene
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=300 --> 447
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: Extension Study to Evaluate the Safety and Efficacy of Luspatercept in Participants With ?-Thalassemia Previously Enrolled in A536-04 (A536-06/MK-6143-004) (clinicaltrials.gov) - Dec 15, 2016
P2, N=64, Active, not recruiting, Sponsor: Acceleron Pharma, Inc.
Recruiting --> Active, not recruiting | N=300 --> 447 Trial primary completion date: Dec 2016 --> Feb 2021
- |||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion, Trial primary completion date: Study to Evaluate the Safety and Efficacy of Luspatercept (ACE-536) in Participants With Beta-thalassemia (A536-04/MK-6143-002) (clinicaltrials.gov) - Dec 13, 2016
P2, N=64, Completed, Sponsor: Acceleron Pharma, Inc.
Trial primary completion date: Dec 2016 --> Feb 2021 Active, not recruiting --> Completed | Trial primary completion date: Nov 2016 --> Nov 2015
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003) (clinicaltrials.gov) - Aug 29, 2016
P2, N=128, Recruiting, Sponsor: Acceleron Pharma, Inc.
Active, not recruiting --> Completed | Trial primary completion date: Nov 2016 --> Nov 2015 Trial primary completion date: Jul 2016 --> Apr 2022
- |||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: MEDALIST: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (clinicaltrials.gov) - Jun 2, 2016
P3, N=210, Recruiting, Sponsor: Celgene Corporation
Trial primary completion date: Jul 2016 --> Apr 2022 Trial primary completion date: Jan 2019 --> Jun 2019
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: AZA-MDS-006: Connect (clinicaltrials.gov) - Apr 19, 2016
P=N/A, N=1500, Recruiting, Sponsor: Celgene Corporation
Trial primary completion date: Jan 2019 --> Jun 2019 Trial primary completion date: Dec 2017 --> Dec 2018
- |||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Enrollment open: BELIEVE: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (?) Thalassemia (clinicaltrials.gov) - Apr 1, 2016
P3, N=300, Recruiting, Sponsor: Celgene Corporation
Trial primary completion date: Dec 2017 --> Dec 2018 Not yet recruiting --> Recruiting
- || Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date: Study to Evaluate the Safety and Efficacy of Luspatercept (ACE-536) in Participants With Beta-thalassemia (A536-04/MK-6143-002) (clinicaltrials.gov) - Jan 17, 2016
P2, N=64, Active, not recruiting, Sponsor: Acceleron Pharma, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Nov 2015 --> Nov 2016