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  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    Optimizing Conditioning for Children and Adolescents with ALL (Room B (2F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_197;    
    These can be manifold and very severe (secondary malignancies, growth retardation, cognitive impairment, infertility, etc.) A further improvement in transplant outcomes by reducing transplant-related morbidity and mortality should be the aim of the next prospective international FORUM 2 study, which is designed as a platform study and aims to answer the several questions. The most important one is to investigate whether a 33% reduction in TBI dose (12Gy vs. 8Gy) in patients aged 2 to 25 years transplanted with an MSD or MD will have the same survival probabilities but a lower rate of short and long-term complications.
  • ||||||||||  Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
    Retrospective data, Journal:  Trabecular bone score and bone frailty: an Italian observational retrospective study. (Pubmed Central) -  Sep 20, 2024   
    Our results seem to suggest that low level of TBS may detect patients that could be more prone to bone frailty consistently with age and BMD at both vertebral and cortical level. However, its role in clinical practice should be refined.
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    Journal:  Allogeneic stem cell transplantation for inherited metabolic disorders: 35 (Pubmed Central) -  Aug 31, 2024   
    We confirm the favorable extramedullary toxicity profile, allowing for potential dose intensification to enhance antileukemic activity. From 2007 onward, intravenous busulfan-based regimens or 4
  • ||||||||||  Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
    Journal:  A UTP3-dependent nucleolar translocation pathway facilitates pre-rRNA 5'ETS processing. (Pubmed Central) -  Jul 22, 2024   
    For the remaining 25 proteins we found that UTP3/SAS10 assists the nucleolar localization of five proteins (MPP10, UTP25, EMG1 and the two UTP-B components UTP12 and UTP13), likely through its interaction with nuclear importin ?...Mechanistically, we found that UTP3 facilitates the degradation of processed 5'ETS by recruiting the RNA exosome component EXOSC10 to the nucleolus. These findings lay the groundwork for studying the mechanism of cytoplasm-to-nucleolus trafficking of SSU processome components.
  • ||||||||||  Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
    Journal:  Multi-scale modelling of location- and frequency-dependent synaptic plasticity induced by transcranial magnetic stimulation in the dendrites of pyramidal neurons. (Pubmed Central) -  Jul 15, 2024   
    The plasticity modelling framework enables precise simulations of LTP-like cellular effects with high spatio-temporal resolution, enhancing the efficiency of parameter screening and the development of plasticity-inducing rTMS protocols. First rigorously validated model of TMS-induced long-term synaptic plasticity in ex- tended neuronal dendrites that goes beyond point-neuron and mean-field modellingRobust simulations of experimental data on LTP-like plasticity in the proximal dendrites of CA1 hippocampal pyramidal cells evoked by 10 Hz repetitive magnetic stimulation (rMS)Replication of distal synaptic plasticity for a local electrical theta burst stimulation (TBS) protocolPrediction of distal and proximal LTP-like plasticity for rMS TBS1 Hz rMS does not induce long-term depression.
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    Retrospective data, Journal:  Treosulfan- versus busulfan-based conditioning in allogeneic hematopoietic cell transplantation for myelodysplastic syndrome: a single-center retrospective propensity score-matched cohort study. (Pubmed Central) -  Jul 4, 2024   
    Using propensity score matching, we compared transplant outcomes between 2 well-matched cohorts who received conditioning with either fludarabine-treosulfan (FT) (n = 46) or fludarabine-busulfan with total body irradiation (FBT200) (n = 92)...Of all participants, 116 (84.0%) received graft-versus-host disease (GVHD) prophylaxis with post-transplant cyclophosphamide (PTCY) and antithymocyte globulin (ATG)...Our study utilized propensity score matching to demonstrate superiority of treosulfan- over busulfan-based conditioning in stem cell transplantation of patients with MDS and is the first to evaluate the performance of treosulfan-based conditioning in combination with ATG and PTCY. As such, it contributes to the increasing body of evidence supporting the safety of treosulfan, even at the dose of 42 g/m2.
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    Journal, CAR T-Cell Therapy, Tumor cell:  Impact of fludarabine and treosulfan on ovarian tumor cells and mesothelin chimeric antigen receptor T cells. (Pubmed Central) -  Jul 2, 2024   
    Combination of treosulfan and fludarabine decreased MSLN-CAR T cells anti-tumor killing in normoxia but not hypoxia. In conclusion, treosulfan and fludarabine killed MSLN?+?ovarian cancer cells without altering MSLN-CAR T cells functions (at low cytostatics concentration) even in hypoxic conditions, and our data support the use of treosulfan and fludarabine as conditioning drugs prior to MSLN-CAR T cell therapy.
  • ||||||||||  Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
    Journal:  Acetylation of transcription factor BpTCP20 by acetyltransferase BpPDCE23 modulates salt tolerance in birch. (Pubmed Central) -  Jun 28, 2024   
    Chromatin immunoprecipitation sequencing showed that BpTCP20 binds to NeuroD1, T-box, and two unknown elements (termed TBS1 and TBS2) to regulate target genes...In addition, we identified dihydrolipoyllysine-residue acetyltransferase component of pyruvate dehydrogenase complex (BpPDCE23), an acetyltransferase that interacts with and acetylates BpTCP20 to enhance its binding to DNA motifs. Together, these results suggest that BpTCP20 is a transcriptional regulator of salt tolerance, whose activity is modulated by BpPDCE23-mediated acetylation.
  • ||||||||||  oNKord (inaleucel) / Glycostem, Medac, Korea Kolmar
    Trial completion date, Trial primary completion date, Combination therapy:  NK4AML: Natural Killer-cell Therapy for Acute Myeloid Leukemia (clinicaltrials.gov) -  Apr 22, 2024   
    P1/2,  N=23, Recruiting, 
    Treatment with melphalan/HDS shows clinically meaningful efficacy and demonstrates a favorable benefit-risk profile in patients with unresectable mUM as compared to best alternative care. Trial completion date: Sep 2023 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2025
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    Biomarker, Enrollment open, Trial primary completion date:  Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant (clinicaltrials.gov) -  Apr 11, 2024   
    P=N/A,  N=144, Recruiting, 
    This study provides evidence that the use of Treosulfan is correlated with a reduced incidence of gonadal toxicity in children undergoing HSCT for hematological malignancies. Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2026 --> Dec 2025
  • ||||||||||  oNKord (inaleucel) / Glycostem, Medac, Korea Kolmar
    Journal, IO biomarker:  Engineering of CD34+ progenitor-derived natural killer cells with higher-affinity CD16a for enhanced antibody-dependent cellular cytotoxicity. (Pubmed Central) -  Feb 26, 2024   
    These findings provide a platform for prospective study and use of vedolizumab for GVHD prophylaxis in pediatric patients with known intestinal inflammation as comorbidity pre-transplant. Together, these data demonstrate that the applicability of adoptive NK cell immunotherapy may be broadened to less NK-sensitive malignancies by upregulation of CD16a expression in combination with the use of tumor-targeting monoclonal antibodies.
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    VISCERAL TOXOCARIAS IN THE EARLY POST-TRANSPLANT COURSE (CLYDE) -  Feb 14, 2024 - Abstract #EBMT2024EBMT_2844;    
    Improving diagnostic and knowing the serological Toxocara status of HSCT recipients may be useful to detect a neglected infection.(1) Haque E, et al. Parasitic infections in hematopoietic stem cell transplant recipients.
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    VISCERAL TOXOCARIAS IN THE EARLY POST-TRANSPLANT COURSE (ePoster area) -  Feb 14, 2024 - Abstract #EBMT2024EBMT_2843;    
    Improving diagnostic and knowing the serological Toxocara status of HSCT recipients may be useful to detect a neglected infection.(1) Haque E, et al. Parasitic infections in hematopoietic stem cell transplant recipients.
  • ||||||||||  Ovastat (treosulfan) / Medac, Medexus
    TREOSULFAN-FLUDARABINE CONDITIONING REGIMEN WITH POST-TRANSPLANT HIGH-DOSE CYCLOPHOSPHAMIDE: A RETROSPECTIVE ANALYSIS (CLYDE) -  Feb 14, 2024 - Abstract #EBMT2024EBMT_2778;    
    In combination with PTCy, short courses of tacrolimus or everolimus and mycophenolate mofetil (MMF) were used as GVHD prophylaxis. Treosulfan-fludarabine conditioning regimen combined with PTCy had low transplantation-related mortality and acceptable relapse rate, especially taking into account the relatively high age of the patients, high or very high DRI in more than half of the patients, and the high proportion of patients with active disease and/or positive MRD at transplant.