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  • ||||||||||  recombinant human erythropoietin / Max Planck Institute, Pfizer
    Review, Journal:  Neuroprotective Effects of Moderate Hypoxia: A Systematic Review. (Pubmed Central) -  Dec 23, 2023   
    We identified 58 eligible studies (k = 8 human studies with N = 274 individuals; k = 48 animal studies) reporting the effects of hypoxia on cognition, motor function, neuroimaging, neuronal/synaptic morphology, inflammation, oxidative stress, erythropoietin, neurotrophins, and Alzheimer's disease markers...Low-dose intermittent or continuous hypoxia repeated for 30-240 min sessions, preferably in combination with motor-cognitive training, produced beneficial effects, and high-dose hypoxia with longer (?6 h) durations and chronic exposure produced more adverse effects. Larger and methodologically stronger translational studies are warranted.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Trial completion, Trial completion date:  SAKK 06/14: VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Apr 13, 2023   
    P1/2,  N=39, Completed, 
    NCT04630730. Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Mar 2023
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Enrollment closed, Trial completion date, Trial primary completion date:  Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence (clinicaltrials.gov) -  Apr 12, 2023   
    P2/3,  N=2000, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Mar 2023 Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Feb 2024 | Trial primary completion date: Feb 2022 --> Feb 2024
  • ||||||||||  recombinant human erythropoietin / Max Planck Institute, Pfizer
    Pro-cognitive effects of intravenous erythropoietin in patientswith schizophrenia () -  Mar 10, 2023 - Abstract #SIRS2023SIR_260;    
    Nonetheless, EPO constitutes a promisingapproach to mitigate cognitive deficits in several patient groups allowing to improve functionaloutcome. Hence, further efforts to establish optimal administration protocols and to promote awidespread use should be supported.KeywordKeywordsCognitive Decline in SchizophreniaPharmacological Treatmentneurodevelopmental disorderspsychosis, cognition, negative symptoms, neurobiologyPoster Award YesPoster Award Eligibility - Young Investigator YesPoster Award Eligibility - SIRS Membership NoPlease list all co-authors for this poster submission.* Presenting AuthorFirst Name Last Name AffiliationMishal * Qubad * Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe University2Karlotta Jacobs Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityCatherine Barnes-Scheufler Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityMareike Aichholzer Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityHannah Wendy Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityHannelore Ehrenreich Clinical Neuroscience, Max PlanckInstitute of Experimental Medicine,G
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Trial completion date, Trial initiation date:  Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa (clinicaltrials.gov) -  Mar 9, 2023   
    P1/2,  N=480, Not yet recruiting, 
    Hence, further efforts to establish optimal administration protocols and to promote awidespread use should be supported.KeywordKeywordsCognitive Decline in SchizophreniaPharmacological Treatmentneurodevelopmental disorderspsychosis, cognition, negative symptoms, neurobiologyPoster Award YesPoster Award Eligibility - Young Investigator YesPoster Award Eligibility - SIRS Membership NoPlease list all co-authors for this poster submission.* Presenting AuthorFirst Name Last Name AffiliationMishal * Qubad * Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe University2Karlotta Jacobs Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityCatherine Barnes-Scheufler Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityMareike Aichholzer Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityHannah Wendy Department of Psychiatry,Psychosomatic Medicine andPsychotherapy, University HospitalFrankfurt, Goethe UniversityHannelore Ehrenreich Clinical Neuroscience, Max PlanckInstitute of Experimental Medicine,G Trial completion date: Sep 2025 --> Mar 2026 | Initiation date: Mar 2023 --> Sep 2023
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Trial completion date:  SAKK 06/14: VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) -  Jan 10, 2023   
    P1/2,  N=39, Active, not recruiting, 
    Further safety trials are needed for the remaining vaccine candidates to confirm safety in vulnerable populations. Trial completion date: Dec 2022 --> Jun 2023
  • ||||||||||  recombinant human erythropoietin / Max Planck Institute, Pfizer
    Review, Journal:  Introducing the brain erythropoietin circle to explain adaptive brain hardware upgrade and improved performance. (Pubmed Central) -  May 31, 2022   
    Here we delineate the brain EPO circle as working model explaining adaptive 'brain hardware upgrade' and improved performance. In this fundamental regulatory circle, neuronal networks, challenged by motor-cognitive tasks, drift into transient 'functional hypoxia', thereby triggering neuronal EPO/EPOR expression.
  • ||||||||||  recombinant human erythropoietin / Max Planck Institute, Pfizer
    Clinical, Journal:  Brain erythropoietin fine-tunes a counterbalance between neurodifferentiation and microglia in the adult hippocampus. (Pubmed Central) -  Feb 12, 2022   
    Surprisingly, EPO affects microglia in phases, initially by inducing apoptosis, later by reducing proliferation, and overall dampens microglia activity and metabolism, as verified by selective genetic targeting of either the microglial or pyramidal neuronal EPO receptor. We suggest that during accelerating neuronal differentiation, EPO acts as regulator of the CSF1R-dependent microglia.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Journal:  An Update on Tuberculosis Vaccines. (Pubmed Central) -  Jan 27, 2022   
    Each vaccine's immunogenicity, safety, and efficacy are tested in preclinical animal models and further validated through various phases of clinical trials. This chapter summarizes the various TB vaccine candidates under different clinical trial stages and promises better protection against TB.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Review, Journal:  Vaccine Development Against Tuberculosis Over the Last 140 Years: Failure as Part of Success. (Pubmed Central) -  Oct 27, 2021   
    It is hoped that highly efficacious vaccines against TB will become available even though it remains unclear whether and when this ambition can be accomplished. None the less it is clear that the goal of reducing TB morbidity and mortality by 90% or 95%, respectively, by 2030 as proposed by the World Health Organization depends significantly on better vaccines.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Journal:  Vaccination Strategies Against Mycobacterium tuberculosis: BCG and Beyond. (Pubmed Central) -  Oct 22, 2021   
    Promising candidates include new generation of live recombinant BCG (rBCG) vaccines, VPM1002, which are deleted in one or two virulence genes...The former vaccine has passed phase IIb in clinical trials involving South African infants and adults. Thus, with an aim of elimination of TB by 2050, all these cumulative efforts to develop a better TB vaccine possibly is new hope for positive outcomes.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Trial completion date, Trial primary completion date:  Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants (clinicaltrials.gov) -  Sep 29, 2021   
    P3,  N=6940, Recruiting, 
    A double-blind, placebo-controlled, randomized clinical trial for proof-of-concept is warranted. Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jul 2023 --> Nov 2022
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Trial completion date, Trial initiation date, Trial primary completion date:  SAKK 06/19: Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC (clinicaltrials.gov) -  Sep 26, 2021   
    P2,  N=46, Not yet recruiting, 
    Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jul 2023 --> Nov 2022 Trial completion date: Sep 2029 --> Jun 2030 | Initiation date: Jul 2021 --> Dec 2021 | Trial primary completion date: Sep 2025 --> Jun 2026
  • ||||||||||  recombinant human erythropoietin / Trillium Therap, Max Planck Institute
    Journal:  CaMKIIα Expressing Neurons to Report Activity-Related Endogenous Hypoxia upon Motor-Cognitive Challenge. (Pubmed Central) -  May 13, 2021   
    We previously introduced the brain erythropoietin (EPO) circle as a model to explain the adaptive 'brain hardware upgrade' and enhanced performance...To conclude, task-associated activity triggers neuronal functional hypoxia as a local and brain-wide reaction mediating adaptive neuroplasticity. Hypoxia-induced genes such as EPO drive neuronal differentiation, brain maturation, and improved performance.
  • ||||||||||  VPM1002 / Max Planck Institute, SAKK, Serum Institute of India
    Review, Journal:  Towards new TB vaccines. (Pubmed Central) -  Apr 28, 2021   
    This encompasses the innate, adaptive, mucosal and humoral immune systems. Though MVA85A did not improve protection compared with BCG alone in a large-scale clinical trial, the correlates of protection this has revealed, in addition to promising results from candidate such as VPM1002, M72/ASO1E and H56:IC31 point to a brighter future in the field of TB vaccine development.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Trial initiation date, Trial primary completion date:  SAKK 06/19: Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC (clinicaltrials.gov) -  Apr 22, 2021   
    P2,  N=62, Not yet recruiting, 
    Though MVA85A did not improve protection compared with BCG alone in a large-scale clinical trial, the correlates of protection this has revealed, in addition to promising results from candidate such as VPM1002, M72/ASO1E and H56:IC31 point to a brighter future in the field of TB vaccine development. Initiation date: Feb 2021 --> Jul 2021 | Trial primary completion date: Feb 2025 --> Sep 2025
  • ||||||||||  VPM1002 / Max Planck Institute, SAKK, Serum Institute of India
    Review, Journal:  Vaccination Against Tuberculosis: Revamping BCG by Molecular Genetics Guided by Immunology. (Pubmed Central) -  Mar 26, 2021   
    A central part of this treatise is the description of the viable BCG-based vaccine, VPM1002, currently undergoing phase III clinical trial assessment. Finally, new approaches which could facilitate design of refined next generation TB vaccines will be discussed.
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  COBRA: Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity (clinicaltrials.gov) -  Mar 21, 2021   
    P3,  N=122, Active, not recruiting, 
    Finally, new approaches which could facilitate design of refined next generation TB vaccines will be discussed. Recruiting --> Active, not recruiting | N=3626 --> 122 | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Apr 2021 --> Sep 2021
  • ||||||||||  VPM1002 / SAKK, Serum Institute of India
    Enrollment open, Trial initiation date:  Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants (clinicaltrials.gov) -  Feb 8, 2021   
    P3,  N=6940, Recruiting, 
    Recruiting --> Active, not recruiting | N=3626 --> 122 | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Apr 2021 --> Sep 2021 Not yet recruiting --> Recruiting | Initiation date: Jun 2020 --> Nov 2020
  • ||||||||||  TMV-018 / Merck (MSD), Max Planck Institute
    Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, IO biomarker:  A Safety Study of TMV-018 in Patients With Tumors of the Gastrointestinal Tract (clinicaltrials.gov) -  Nov 25, 2020   
    P1,  N=0, Withdrawn, 
    Recruiting --> Active, not recruiting N=15 --> 0 | Trial completion date: Dec 2023 --> Nov 2020 | Initiation date: Jun 2020 --> Nov 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2021 --> Nov 2020