Winrevair (sotatercept-csrk) / BMS, Merck (MSD) 
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 16 Diseases   13 Trials   13 Trials   579 News 


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  • ||||||||||  Reblozyl (luspatercept-aamt) / Acceleron, BMS
    Review, Journal:  Myelo-deception: Luspatercept & TGF-Beta ligand traps in myeloid diseases & anemia. (Pubmed Central) -  Dec 16, 2020   
    Our review will discuss luspatercept, a transforming growth factor (TGF)-Beta ligand trap, the first new Food & Drug Administration (FDA)-approved treatment in MDS in over a decade. We will explore the different TGF-Beta ligand traps that have been developed for a number of diseases, with a focus on myeloid malignancies.
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS, Reblozyl (luspatercept-aamt) / Acceleron, BMS
    Review, Journal:  Activin Receptor-Ligand Trap for the Treatment of β-thalassemia: A Serendipitous Discovery. (Pubmed Central) -  Nov 18, 2020   
    In this review, we describe in extenso the TGF-β pathway, as well as the molecular and biological basis of activin receptors ligand traps, focusing on their role in various β-thalassemia experimental models. The most recent results from clinical trials on sotatercept and luspatercept will also be reviewed.
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS
    [VIRTUAL] Sotatercept (ACE-011) for Anemia of Myelofibrosis: A Phase 2 Study (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_2623;    
    P2
    Current therapies for anemia of MF (erythropoietin and analogs, danazol, IMiDs®) are unsatisfactory...Conclusions Sotatercept is safe and effective against anemia of MPN-associated MF, both in non-TD and TD pts, with a response rate of 29% both when used alone and in conjunction with a stable dose of rux. A total of 60 pts are planned to be treated on this trial (NCT01712308).
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS
    [VIRTUAL] Sotatercept Analog RAP-011 Inhibits Right Ventricular Remodeling and Restores Function in a Mouse Model of Pressure Overload (OnDemand) -  Sep 17, 2020 - Abstract #AHA2020AHA_3356;    
    The purpose of this article is to review the previous literature on DBA and weigh the role of newer therapeutic agents. Consistent with our previous findings in a rat model of severe angio-obliterative PAH, RAP-011 treatment reduces RV remodeling and improves function in a PAB model, thus implicating direct cardioprotective actions of RAP-011 as an important component of its therapeutic effects in severe experimental PAH.
  • ||||||||||  Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
    Trial completion date, Trial primary completion date:  Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia (clinicaltrials.gov) -  Aug 9, 2020   
    P2,  N=60, Recruiting, 
    Consistent with our previous findings in a rat model of severe angio-obliterative PAH, RAP-011 treatment reduces RV remodeling and improves function in a PAB model, thus implicating direct cardioprotective actions of RAP-011 as an important component of its therapeutic effects in severe experimental PAH. Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Feb 2020 --> Feb 2021
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS, Reblozyl (luspatercept-aamt) / Acceleron, BMS
    Review, Journal:  Activin Receptor II Ligand Traps: New Treatment Paradigm for Low-Risk MDS. (Pubmed Central) -  Jul 29, 2020   
    A phase III randomized clinical trial with luspatercept was recently conducted. Activin receptor II ligand traps may represent a new paradigm for anemia treatment in MDS.
  • ||||||||||  sotatercept (MK-7962) / BMS, Merck (MSD)
    Trial completion date:  PULSAR: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) -  Jul 14, 2020   
    P2,  N=100, Active, not recruiting, 
    Our results indicate that combination therapy with RAP-011 exerts effects superior to sildenafil alone and that benefits of RAP-011 persist 4 weeks after cessation of monotherapy. Trial completion date: Nov 2021 --> May 2022
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS
    [VIRTUAL] Sotatercept for the Treatment of Pulmonary Arterial Hypertension (ATS 2020 Virtual) -  Jul 6, 2020 - Abstract #ATSI2020ATS-I_2391;    
    This mechanism of action could potentially translate to clinical benefits beyond those of currently available therapies for PAH treatment. There is no abstract associated with this presentation.
  • ||||||||||  Review, Journal:  Chronic Myelomonocytic Leukemia: 2018 Update to Prognosis and Treatment. (Pubmed Central) -  Jul 4, 2020   
    Increased recognition and interest in CMML have led to the development of a number of new prognostic models and potential treatment options. Standard treatment options remain limited and clinical trials should be strongly considered whenever available.
  • ||||||||||  Jakafi oral (ruxolitinib) / Novartis, Incyte, azacitidine / Generic mfg.
    Clinical, Review, Journal:  New Concepts of Treatment for Patients with Myelofibrosis. (Pubmed Central) -  Mar 26, 2020   
    Pacritinib, a non-myelosuppressive JAK2-selective inhibitor, is currently in a dose-ranging study mandated by regulatory authorities...Emerging data supports the addition of azacitidine to ruxolitinib in some patients...This is important, because cytopenias are the commonest reason for ruxolitinib interruption and/or dose reduction, and dose optimization of ruxolitinib is tied to its survival benefit. The activin receptor ligand trap, sotatercept, and the anti-fibrotic agent, PRM-151, have shown promise in this regard.
  • ||||||||||  Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
    Trial completion date, Trial primary completion date:  SPECTRA: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Mar 18, 2020   
    P2a,  N=25, Recruiting, 
    The activin receptor ligand trap, sotatercept, and the anti-fibrotic agent, PRM-151, have shown promise in this regard. Trial completion date: Sep 2020 --> Dec 2022 | Trial primary completion date: May 2020 --> Dec 2021
  • ||||||||||  Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
    Trial completion date, Trial primary completion date:  Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia (clinicaltrials.gov) -  Feb 23, 2020   
    P1/2,  N=20, Recruiting, 
    This mechanism of action could potentially translate to clinical benefits beyond those of currently available therapies for PAH treatment. Trial completion date: May 2020 --> May 2021 | Trial primary completion date: Mar 2020 --> Mar 2021
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS
    Sotatercept for Treatment of PAH (PENNSYLVANIA CONVENTION CENTER, Terrace Ballroom I (Terrace Ballroom Level)) -  Jan 30, 2020 - Abstract #ATS2020ATS_71;    
    Trial completion date: May 2020 --> May 2021 | Trial primary completion date: Mar 2020 --> Mar 2021 There is no abstract associated with this presentation.
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS
    Clinical, Journal:  Sotatercept Safety and Effects on Hemoglobin, Bone, and Vascular Calcification. (Pubmed Central) -  Jan 1, 2020   
    In patients with ESKD, sotatercept exhibited a favorable safety profile and was associated with trends in dose-related slowing of vascular calcification. Less-consistent trends in improved hemoglobin concentration and BMD were observed.
  • ||||||||||  sotatercept (ACE-011) / Acceleron, BMS
    Journal:  Development of two complementary LC-HRMS methods for analyzing sotatercept in dried blood spots for doping controls. (Pubmed Central) -  Nov 23, 2019   
    Results &  For the multianalyte ITP, artificial samples fortified with sotatercept, luspatercept and bimagrumab, and authentic specimens containing bimagrumab were successfully analyzed as proof-of-concept. The validated detection methods for sotatercept are fit for purpose and the ITP was shown to be suitable for the detection of novel IgG-based pharmaceuticals in doping control DBS samples.
  • ||||||||||  luspatercept (ACE-536) / Celgene, Acceleron
    Journal:  Luspatercept for the treatment of anemia in myelodysplastic syndromes (MDS) and primary myelofibrosis (PMF). (Pubmed Central) -  Oct 25, 2019   
    The TGF-β superfamily, including activins and growth differentiation factors (GDF), is aberrantly expressed in lower risk MDS and PMF. Luspatercept (and Sotatercept), ligand traps that particularly inhibit GDF 11, lead to RBC transfusion independence in 10-50% of lower risk MDS resistant to available treatments, and have started to be used in PMF.
  • ||||||||||  galunisertib (LY2157299) / Eli Lilly, sotatercept (ACE-011) / Celgene, Acceleron, luspatercept (ACE-536) / Celgene, Acceleron
    Progress in Targeting the TGFβ Pathway () -  Sep 26, 2019 - Abstract #SOHO2019SOHO_269;    
    Moreover, biological activity of activin receptor ligand traps provides a basis for novel fusion proteins such as luspatercept. These erythroid maturation agents show promise in in alleviating anemia and related comorbidities in MDS and other conditions characterized by erythroid maturation defects.
  • ||||||||||  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.
  • ||||||||||  sotatercept (ACE-011) / Celgene, Acceleron
    Using SPECTrum of Innovative Endpoints to Examine Sotatercept (102AB) -  Aug 21, 2019 - Abstract #AHA2019AHA_164;    
    A related study (SPECTRA; NCT03738150) will evaluate the effects of sotatercept on cardiopulmonary hemodynamics and functional capacity in pts with PAH. There is no abstract associated with this presentation.
  • ||||||||||  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.
  • ||||||||||  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.
  • ||||||||||  Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
    Enrollment open:  SPECTRA: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (clinicaltrials.gov) -  Mar 21, 2019   
    P2a,  N=25, Recruiting, 
    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
  • ||||||||||  Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
    Enrollment closed, Trial completion date, Trial primary completion date:  Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia (clinicaltrials.gov) -  Mar 13, 2019   
    P1/2,  N=20, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Mar 2019 --> May 2020 | Trial primary completion date: Mar 2019 --> Mar 2020