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  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    [VIRTUAL] Current Ultimate Choice for Conditioning Regimens (CHANNEL B) -  Jul 31, 2021 - Abstract #ICBMT2021ICBMT_38;    
    The primary study aim was to show that a non-TBI containing regimen (fludarabine (flu)/thiotepa (thio)/i.v...After random assignment of 417 pediatric patients with high-risk ALL, a futility stopping rule was applied because patients receiving chemocon- ditioning with fludarabine, thiotepa, and either busulfan or treosulfan had inferior overall survival (OS) to those receiving TBI plus etoposide...In the next years, clinical trials have to define the appropriate role of allogeneic HSCT in the context of new and hopefully less toxic treatment options. However, it is still the most powerful tool for leukemia control through the graft versus leukemia effect.
  • ||||||||||  Natesto (testosterone) / Acerus, Medac, Aytu BioPharma, Nebido (testosterone undecanoate depot injection) / Bayer
    Journal:  Jatenzo - an oral testosterone for hypogonadism. (Pubmed Central) -  Jul 14, 2021   
    Treatment with SYD985 significantly improved PFS in comparison with standard PC and may provide a new treatment option for patients with pre-treated locally advanced or metastatic HER2-positive MBC. No abstract available
  • ||||||||||  dexamethasone / Generic mfg.
    Journal:  Biomodulatory Treatment Regimen, MEPED, Rescues Relapsed and Refractory Classic Hodgkin's Disease. (Pubmed Central) -  Jul 6, 2021   
    MEPED is well tolerated with low toxicity and highly efficacious in relapsed/refractory cHL, including severely comorbid patients. Due to its immunomodulatory components, MEPED might also have a synergistic potential when combined with ICPi but requires further evaluation within a clinical trial.
  • ||||||||||  Orencia (abatacept) / BMS, Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Actemra IV (tocilizumab) / Roche, JW Pharma
    Retrospective data, Journal:  Serotherapy-Free Regimen Improves Non-Relapse Mortality and Immune Recovery Among the Recipients of αβ TCell-Depleted Haploidentical Grafts: Retrospective Study in Childhood Leukemia. (Pubmed Central) -  Jul 4, 2021   
    Thiotepa, fludarabine, bortezomib, and rituximab were used as additional agents...Recovery of both αβ- and γδ- T cells was significantly improved at days +30 and +60 after HSCT in recipients of ATG-free preparative regimens, as well as recovery of naïve T cells. Among the recipients of αβ T-cell-depleted grafts, replacement of ATG with nonlymphodepleting abatacept and tocilizumab immunomodulation did not compromise engraftment and GVHD control and was associated with significantly lower NRM and better immune recovery early after HSCT.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Trial primary completion date:  AALL1331: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) -  Jul 2, 2021   
    P3,  N=670, Active, not recruiting, 
    Among the recipients of αβ T-cell-depleted grafts, replacement of ATG with nonlymphodepleting abatacept and tocilizumab immunomodulation did not compromise engraftment and GVHD control and was associated with significantly lower NRM and better immune recovery early after HSCT. Trial primary completion date: Dec 2022 --> Jun 2021
  • ||||||||||  Natesto (testosterone) / Acerus, Medac, Aytu Biosci
    Clinical, Journal:  Use of trabecular bone score for risk stratification of patients with monoclonal gammopathy of undetermined significance. (Pubmed Central) -  Jun 22, 2021   
    Although fractures occurred more commonly in those control subjects with significantly lower TBS values, this was not the case in subjects with MGUS (TBS 1.299 vs. 1.313 in cases with vs. without fractures p = 0.313)...Despite patients with MGUS having a significantly increased fracture risk compared to age-, sex- and BMI-matched control subjects, neither assessment of BMD nor TBS, obtained within two years of MGUS diagnosis, were able to accurately risk stratify MGUS patients. Unlike control subjects, patients with MGUS tend to fracture despite normal BMD and intermediate or normal TBS values, suggesting that deterioration of cortical rather than trabecular skeletal components may be more important for the increased fracture risk seen in MGUS.
  • ||||||||||  Ovastat (treosulfan) / Medac
    Review, Journal, IO biomarker:  Treosulfan-based conditioning for inborn errors of immunity. (Pubmed Central) -  Jun 8, 2021   
    Such conditioning regimens can be used as the basis to study the need for additional agents in certain disorders which are difficult to engraft or require high levels of donor chimerism, the dosing of individual cellular components within grafts, and effects of adjuvant cellular or immunotherapy post-transplant. This review documents the establishment of treosulfan worldwide, as a safe and effective agent for conditioning children with IEI prior to HSCT.
  • ||||||||||  oNKord (GCT NK cells) / Glycostem, Radboud University
    [VIRTUAL] Human glioblastoma cells are sensitive to NK-cell mediated killing in vitro. () -  May 30, 2021 - Abstract #EACR2021EACR_2167;    
    We believe that this correlation will help to identify the killings mechanisms of GTA002 as an allogeneic cellular therapy. Conclusion Our experimental data provide preclinical in vitro evidence for further investigation of the potential of adoptive NK cell therapy against glioblastoma.
  • ||||||||||  oNKord (GCT NK cells) / Glycostem, Radboud University
    [VIRTUAL] Human glioblastoma cells are sensitive to NK-cell mediated killing in vitro. () -  May 30, 2021 - Abstract #EACR2021EACR_2166;    
    We believe that this correlation will help to identify the killings mechanisms of GTA002 as an allogeneic cellular therapy. Conclusion Our experimental data provide preclinical in vitro evidence for further investigation of the potential of adoptive NK cell therapy against glioblastoma.
  • ||||||||||  oNKord (GCT NK cells) / Glycostem, Radboud University
    [VIRTUAL] Human glioblastoma cells are sensitive to NK-cell mediated killing in vitro. () -  May 30, 2021 - Abstract #EACR2021EACR_2165;    
    We believe that this correlation will help to identify the killings mechanisms of GTA002 as an allogeneic cellular therapy. Conclusion Our experimental data provide preclinical in vitro evidence for further investigation of the potential of adoptive NK cell therapy against glioblastoma.
  • ||||||||||  oNKord (GCT NK cells) / Glycostem, Radboud University
    [VIRTUAL] Human glioblastoma cells are sensitive to NK-cell mediated killing in vitro. () -  May 30, 2021 - Abstract #EACR2021EACR_2164;    
    We believe that this correlation will help to identify the killings mechanisms of GTA002 as an allogeneic cellular therapy. Conclusion Our experimental data provide preclinical in vitro evidence for further investigation of the potential of adoptive NK cell therapy against glioblastoma.
  • ||||||||||  Revlimid (lenalidomide) / BMS, Darzalex IV (daratumumab) / J&J
    [VIRTUAL] Ex vivo expanded NK cells exhibit potent cytotoxicity against multiple myeloma. () -  May 30, 2021 - Abstract #EACR2021EACR_2163;    
    We aimed to investigate whether our GTA002 NK cell product, expanded and differentiated ex vivo from cord-blood derived CD34+ hematopoietic stem cells, will in vitro effectively kill target various MM cell lines...Representative model MM cell lines were chosen based on their sensitivity/resistance to lenalidomide, bortezomib (BTZ) and CD38 surface expression, latter associated with responsiveness to daratumumab treatment: MM.1S, LP1, NCI-H292, OPM2, RPMI-8226, U266B1, KMS11 and KMS11/BTZ...Receptor and ligand expression of effector and target cells, respectively, will be determined by flow cytometry Results and Discussions We observed cytotoxicity of GT002 at E:T ratio 10:1 in all model MM cell lines irrespective of their chemoresistance status or CD38 surface antigen density...More importantly, we observed high killing efficiency also in U266B1 cells with low CD38 expression, which is indicative of the refractoriness to daratumumab therapy. Conclusion Our experimental data show proof of efficient cytotoxic capacity of ex vivo expanded NK cells against MM in vitro, and a strong indication that they can provide a novel source of cellular immunotherapy used to treat MM patient target groups with unmet medical needs, including those with relapsed refractory disease.
  • ||||||||||  Revlimid (lenalidomide) / BMS, Darzalex IV (daratumumab) / J&J
    [VIRTUAL] Ex vivo expanded NK cells exhibit potent cytotoxicity against multiple myeloma. () -  May 30, 2021 - Abstract #EACR2021EACR_2162;    
    We aimed to investigate whether our GTA002 NK cell product, expanded and differentiated ex vivo from cord-blood derived CD34+ hematopoietic stem cells, will in vitro effectively kill target various MM cell lines...Representative model MM cell lines were chosen based on their sensitivity/resistance to lenalidomide, bortezomib (BTZ) and CD38 surface expression, latter associated with responsiveness to daratumumab treatment: MM.1S, LP1, NCI-H292, OPM2, RPMI-8226, U266B1, KMS11 and KMS11/BTZ...Receptor and ligand expression of effector and target cells, respectively, will be determined by flow cytometry Results and Discussions We observed cytotoxicity of GT002 at E:T ratio 10:1 in all model MM cell lines irrespective of their chemoresistance status or CD38 surface antigen density...More importantly, we observed high killing efficiency also in U266B1 cells with low CD38 expression, which is indicative of the refractoriness to daratumumab therapy. Conclusion Our experimental data show proof of efficient cytotoxic capacity of ex vivo expanded NK cells against MM in vitro, and a strong indication that they can provide a novel source of cellular immunotherapy used to treat MM patient target groups with unmet medical needs, including those with relapsed refractory disease.
  • ||||||||||  Revlimid (lenalidomide) / BMS, Darzalex IV (daratumumab) / J&J
    [VIRTUAL] Ex vivo expanded NK cells exhibit potent cytotoxicity against multiple myeloma. () -  May 30, 2021 - Abstract #EACR2021EACR_2161;    
    We aimed to investigate whether our GTA002 NK cell product, expanded and differentiated ex vivo from cord-blood derived CD34+ hematopoietic stem cells, will in vitro effectively kill target various MM cell lines...Representative model MM cell lines were chosen based on their sensitivity/resistance to lenalidomide, bortezomib (BTZ) and CD38 surface expression, latter associated with responsiveness to daratumumab treatment: MM.1S, LP1, NCI-H292, OPM2, RPMI-8226, U266B1, KMS11 and KMS11/BTZ...Receptor and ligand expression of effector and target cells, respectively, will be determined by flow cytometry Results and Discussions We observed cytotoxicity of GT002 at E:T ratio 10:1 in all model MM cell lines irrespective of their chemoresistance status or CD38 surface antigen density...More importantly, we observed high killing efficiency also in U266B1 cells with low CD38 expression, which is indicative of the refractoriness to daratumumab therapy. Conclusion Our experimental data show proof of efficient cytotoxic capacity of ex vivo expanded NK cells against MM in vitro, and a strong indication that they can provide a novel source of cellular immunotherapy used to treat MM patient target groups with unmet medical needs, including those with relapsed refractory disease.
  • ||||||||||  Revlimid (lenalidomide) / BMS, Darzalex IV (daratumumab) / J&J
    [VIRTUAL] Ex vivo expanded NK cells exhibit potent cytotoxicity against multiple myeloma. () -  May 30, 2021 - Abstract #EACR2021EACR_2160;    
    We aimed to investigate whether our GTA002 NK cell product, expanded and differentiated ex vivo from cord-blood derived CD34+ hematopoietic stem cells, will in vitro effectively kill target various MM cell lines...Representative model MM cell lines were chosen based on their sensitivity/resistance to lenalidomide, bortezomib (BTZ) and CD38 surface expression, latter associated with responsiveness to daratumumab treatment: MM.1S, LP1, NCI-H292, OPM2, RPMI-8226, U266B1, KMS11 and KMS11/BTZ...Receptor and ligand expression of effector and target cells, respectively, will be determined by flow cytometry Results and Discussions We observed cytotoxicity of GT002 at E:T ratio 10:1 in all model MM cell lines irrespective of their chemoresistance status or CD38 surface antigen density...More importantly, we observed high killing efficiency also in U266B1 cells with low CD38 expression, which is indicative of the refractoriness to daratumumab therapy. Conclusion Our experimental data show proof of efficient cytotoxic capacity of ex vivo expanded NK cells against MM in vitro, and a strong indication that they can provide a novel source of cellular immunotherapy used to treat MM patient target groups with unmet medical needs, including those with relapsed refractory disease.
  • ||||||||||  Ovastat (treosulfan) / Medac
    Clinical, Journal:  Allogeneic hematopoietic stem cell transplantation in leukocyte adhesion deficiency type I and III. (Pubmed Central) -  May 15, 2021   
    The choice of busulfan- or treosulfan-based conditioning, type of GVHD prophylaxis, and serotherapy did not impact overall survival, EFS, or aGVHD. An intrinsic inflammatory component of LAD may contribute to inflammatory complications during allo-HSCT, thus providing the rationale for considering anti-inflammatory therapy pretreatment.
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] SECOND ALLOGENEIC STEM CELL TRANSPLANTATION FOR SECONDARY AML RELAPSING AFTER FIRST TRANSPLANTATION-A COMPARISON BETWEEN MYELOABLATIVE AND REDUCED INTENSITY CONDITIONING: FROM THE ALWP OF THE EBMT () -  May 13, 2021 - Abstract #EHA2021EHA_953;    
    The most frequent RIC was Fludarabine/ Busulfan (Flu/Bu)-13.2%, Flu/TBI-10.1%, and Flu/Melphalan (Mel)-9.3%, while the most frequent MAC was Flu/Bu-9%, Flu/Thiotepa (Thio)/Treosulfan (Treo)-9%, and Flu/TBI-6.4%...Graft-versus-host disease (GVHD) prophylaxis was cyclosporine A (CSA)/mycophenolate mofetil + ATG in 31.9 % and 34.7%, and CSA/methotrexate + ATG in 15.9% and 19.4% of the pts...Disease status, time from HSCT1 to relapse, and KPS are additional prognostic factors for transplantation outcome. These results are consistent with our previously reported findings in pts with sAML undergoing HSCT1 (Blood Advances 2:2127-2135, 2018), in favor of MAC for pts with sAML who received an HSCT2 after relapse.
  • ||||||||||  GTA102 / Glycostem, oNKord (GCT NK cells) / Glycostem, Radboud University
    [VIRTUAL] Enhancing functionality of NK cells towards colorectal cancer cell lines (eTalks Room) -  May 11, 2021 - Abstract #CIMT2021CIMT_141;    
    It is essential to evaluate the potency of cell-based immunotherapy products in both 2D and 3D settings to target solid tumors efficiently. Most importantly, our results demonstrate that introduction of CAR to NK cells significantly improves targeting of UCB-NK cell resistant antigen+ CRC cells and stands out as a potential cell therapy product for the treatment of colorectal cancer patients.
  • ||||||||||  oNKord (GCT NK cells) / Glycostem, Radboud University
    [VIRTUAL] Ex vivo expanded NK cells show potent anti-tumour activity against melanoma (eTalks Room) -  May 11, 2021 - Abstract #CIMT2021CIMT_112;    
    Our data show that GTA002 NK cells exert efficient anti-tumour activity against melanoma cell lines in vitro. In order to better understand the differences in susceptibility to NK cell mediated killing between the different melanoma cell lines, we will further investigate the involvement of different killing mechanisms taking into account the contribution of the individual ligand expression profile of melanomas to NK cell activation.