DOCSLIB.ORG

Clinical Trials: Biologics

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Clinical Trials: Biologics Clinical Trials: Biologics The 794 clinical trials listed here include 419 that have not yet started recruiting patients or are just now seeking volunteers to participate and another 375 that are active, but not recruiting new patients. This information is potentially valuable to patients still seeking effective treatments for hundreds of diseases, including autoimmune disorders, cancer, cardiovascular diseases, diabetes, infectious diseases, neurological disorders, and many more. It provides a new therapeutic option to discuss with physicians. Those interested in obtaining more information about certain clinical trials can use the URL code listed for each trial to log onto www.clinicaltrials.gov, the clinical tests database of the National Institutes of Health. Autoimmune Disorders 39 Blood Disorders 34 Cancer 384 Cardiovascular Disease 34 Diabetes 5 Digestive Disorders 18 Eye Disorders 14 Genetic Disorders 16 Infectious Diseases 122 Musculoskeletal Disorders 33 Neurological Disorders 18 Respiratory Diseases 8 Skin Diseases115 15 Transplantation 5 Others 49 Source: www.clinicaltrials.gov; Search criteria: Biological, Phase 0, 1, 2, 3; industry only, United States. Included are only active clinical trials – active, not recruiting; recruiting, not yet recruiting, and enrolling by invitation. Search performed 2/5/2013. Autoimmune disorders – 39 Active Clinical Trials — Psoriasis is listed under Skin Disorders — Study 1 – Recruiting Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis Multiple Sclerosis, Secondary Progressive http://ClinicalTrials.gov/show/NCT01684761 Study 2 – Active, not recruiting A Study of the Safety and Tolerability of MEDI-551 in Scleroderma Scleroderma http://ClinicalTrials.gov/show/NCT00946699 Study 3 – Recruiting A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01) Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01526057 Study 4 – Active, not recruiting A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting http://ClinicalTrials.gov/show/NCT00050778 Study 5 – Active, not recruiting An Efficacy and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis (RA) Despite Treatment With Methotrexate, Non Steroidal Pain Medications and/or Corticosteroids Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT00973479 Study 6 – Recruiting A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus http://ClinicalTrials.gov/show/NCT01484496 Study 7 – Active, not recruiting Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01559103 Study 8 – Active, not recruiting Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01373151 Study 9 – Recruiting Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus Systemic Lupus Erythematosus http://ClinicalTrials.gov/show/NCT01405196 Study 10 – Recruiting Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01359943 Study 11 – Active, not recruiting An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme- Sponsored Studies of Alemtuzumab Multiple Sclerosis, Relapsing-Remitting http://ClinicalTrials.gov/show/NCT00930553 Study 12 – Recruiting Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis Lupus Nephritis | Systemic Lupus Erythematosus http://ClinicalTrials.gov/show/NCT01639339 Study 13 – Recruiting A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) Juvenile Idiopathic Arthritis http://ClinicalTrials.gov/show/NCT01230827 Study 14 – Active, not recruiting A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States Systemic Lupus Erythematosus http://ClinicalTrials.gov/show/NCT00724867 Study 15 – Active, not recruiting A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01712178 Study 16 – Recruiting A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus Systemic Lupus Erythematosus http://ClinicalTrials.gov/show/NCT01438489 Study 17 – Recruiting Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drug (DMARD)-Naïve Adults With Early Active Rheumatoid Arthritis Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01519791 Study 18 – Active, not recruiting A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) Juvenile Idiopathic Arthritis http://ClinicalTrials.gov/show/NCT01777399 Study 19 – Recruiting A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01636817 Study 20 – Recruiting Study of Veltuzumab (hA20) at Different Doses in Patients With ITP Idiopathic Thrombocytopenic Purpura http://ClinicalTrials.gov/show/NCT00547066 Study 21 – Active, not recruiting An Immunogenicity and Pharmacokinetics (PK) Study of DAC HYP Prefilled Syringe in Relapsing Remitting Multiple Sclerosis (RRMS) Multiple Sclerosis, Relapsing Remitting http://ClinicalTrials.gov/show/NCT01462318 Study 22 – Recruiting Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing- Remitting Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting http://ClinicalTrials.gov/show/NCT01585766 Study 23 – Active, not recruiting Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFα Therapies Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT00468546 Study 24 – Active, not recruiting Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01261403 Study 25 – Active, not recruiting Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056 Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01296711 Study 26 – Recruiting IGIV Study for Chronic ITP Patients Ages 3-70 Idiopathic Thrombocytopenic Purpura http://ClinicalTrials.gov/show/NCT00511147 Study 27 – Recruiting A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura Idiopathic Thrombocytopenic Purpura http://ClinicalTrials.gov/show/NCT01071954 Study 28 – Recruiting Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01752855 Study 29 – Active, not recruiting A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02 Systemic Lupus Erythematosus http://ClinicalTrials.gov/show/NCT00583362 Study 30 – Active, not recruiting Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis Pulmonary Sarcoidosis http://ClinicalTrials.gov/show/NCT01440192 Study 31 – Not yet recruiting The Evaluation of Belimumab in Myasthenia Gravis (MG) Myasthenia Gravis http://ClinicalTrials.gov/show/NCT01480596 Study 32 – Active, not recruiting Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT00425932 Study 33 – Recruiting Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01333878 Study 34 – Recruiting Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01351480 Study 35 – Recruiting A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01636843 Study 36 – Recruiting Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim Idiopathic Thrombocytopenic Purpura http://ClinicalTrials.gov/show/NCT01143038 Study 37 – Recruiting Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents Rheumatoid Arthritis http://ClinicalTrials.gov/show/NCT01377012 Study 38 – Recruiting Balancing Lupus Experiences With Stress Strategies
Load more

Recommended publications
  • WHO Drug Information Vol. 12, No. 3, 1998
    WHO DRUG INFORMATION VOLUME 12 NUMBER 3 • 1998 RECOMMENDED INN LIST 40 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA Volume 12, Number 3, 1998 World Health Organization, Geneva WHO Drug Information Contents Seratrodast and hepatic dysfunction 146 Meloxicam safety similar to other NSAIDs 147 Proxibarbal withdrawn from the market 147 General Policy Issues Cholestin an unapproved drug 147 Vigabatrin and visual defects 147 Starting materials for pharmaceutical products: safety concerns 129 Glycerol contaminated with diethylene glycol 129 ATC/DDD Classification (final) 148 Pharmaceutical excipients: certificates of analysis and vendor qualification 130 ATC/DDD Classification Quality assurance and supply of starting (temporary) 150 materials 132 Implementation of vendor certification 134 Control and safe trade in starting materials Essential Drugs for pharmaceuticals: recommendations 134 WHO Model Formulary: Immunosuppressives, antineoplastics and drugs used in palliative care Reports on Individual Drugs Immunosuppresive drugs 153 Tamoxifen in the prevention and treatment Azathioprine 153 of breast cancer 136 Ciclosporin 154 Selective serotonin re-uptake inhibitors and Cytotoxic drugs 154 withdrawal reactions 136 Asparaginase 157 Triclabendazole and fascioliasis 138 Bleomycin 157 Calcium folinate 157 Chlormethine 158 Current Topics Cisplatin 158 Reverse transcriptase activity in vaccines 140 Cyclophosphamide 158 Consumer protection and herbal remedies 141 Cytarabine 159 Indiscriminate antibiotic
    [Show full text]
  • The Double Stranded RNA Analog Poly-IC Elicits Both Robust IFN-Λ Production and Oncolytic Activity in Human Gastrointestinal Cancer Cells
    www.oncotarget.com Oncotarget, 2018, Vol. 9, (No. 77), pp: 34471-34484 Research Paper The double stranded RNA analog poly-IC elicits both robust IFN-λ production and oncolytic activity in human gastrointestinal cancer cells Chantal Bou-Hanna1,*, Anne Jarry1,2,*, Jean-François Mosnier1,3, Céline Bossard1,2,3 and Christian L. Laboisse1,3 1University of Nantes, EA4273 Biometadys, Nantes, France 2Current address: CRCINA, INSERM, Université d’Angers, Université de Nantes, Nantes, France 3Pathology Department, Nantes University Hospital, Nantes, France *Equal co-authors Correspondence to: Christian L. Laboisse, email: [email protected]; [email protected] Keywords: dsRNA/poly-IC; IFN-λ; immunoadjuvant; oncolysis; human gastrointestinal cancer Received: February 09, 2018 Accepted: September 06, 2018 Published: October 02, 2018 Copyright: Bou-Hanna et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ABSTRACT Purpose: Type III IFN (IFN-λ) is the dominant frontline response over type I IFN in human normal intestinal epithelial cells upon viral infection, this response being mimicked by the dsRNA analog poly-IC. Poly-IC also induces cell death in murine intestinal crypts ex vivo. Here we examined whether these innate defense functions of normal intestinal epithelial cells are recapitulated in gastrointestinal carcinoma cells so that they could be harnessed to exert both immunoadjuvant and oncolytic functions, an unknown issue yet. Experimental design: Four human gastrointestinal carcinoma cell lines versus the Jurkat lymphoma cell line were used to assess the effects of intracellular poly-IC on i) IFN-λ secretion and cell proliferation and ii) role of NFκB signaling using the NFκB inhibitory peptide SN50 as a screening probe and a siRNA approach.
    [Show full text]
  • Patient Resource Free
    PATIENT RESOURCE FREE Third Edition CancerUnderstanding Immunotherapy Published in partnership with CONTENT REVIEWED BY A DISTINGUISHED PRP MEDICAL PATIENT ADVISORY RESOURCE BOARD PUBLISHING® Understanding TABLE OF CONTENTS Cancer Immunotherapy Third Edition IN THIS GUIDE 1 Immunotherapy Today 2 The Immune System 4 Immunotherapy Strategies 6 Melanoma Survivor Story: Jane McNee Chief Executive Officer Mark A. Uhlig I didn’t look sick, so I didn’t want to act sick. Publisher Linette Atwood Having and treating cancer is only one part of your life. Co-Editor-in-Chief Charles M. Balch, MD, FACS Jane McNee, melanoma survivor Co-Editor-in-Chief Howard L. Kaufman, MD, FACS Senior Vice President Debby Easum 7 The Road to Immunotherapy Vice President, Operations Leann Sandifar 8 Cancer Types Managing Editor Lori Alexander, MTPW, ELS, MWC™ 14 Side Effects Senior Editors Dana Campbell Colleen Scherer 15 Glossary Graphic Designer Michael St. George 16 About Clinical Trials Medical Illustrator Todd Smith 16 Cancer Immunotherapy Clinical Trials by Disease Production Manager Jennifer Hiltunen 35 Support & Financial Resources Vice Presidents, Amy Galey Business Development Kathy Hungerford 37 Notes Stephanie Myers Kenney Account Executive Melissa Amaya Office Address 8455 Lenexa Drive CO-EDITORS-IN-CHIEF Overland Park, KS 66214 For Additional Information [email protected] Charles M. Balch, MD, FACS Advisory Board Visit our website at Professor of Surgery, The University of Texas PatientResource.com to read bios of MD Anderson Cancer Center our Medical and Patient Advisory Board. Editor-in-Chief, Patient Resource LLC Editor-in-Chief, Annals of Surgical Oncology Past President, Society of Surgical Oncology For Additional Copies: To order additional copies of Patient Resource Cancer Guide: Understanding Cancer Immunotherapy, Howard L.
    [Show full text]
  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
    [Show full text]
  • And Poly-ICLC in Glioblastoma
    De Waele et al. Journal of Experimental & Clinical Cancer Research (2021) 40:213 https://doi.org/10.1186/s13046-021-02017-2 REVIEW Open Access A systematic review on poly(I:C) and poly- ICLC in glioblastoma: adjuvants coordinating the unlocking of immunotherapy Jorrit De Waele1* , Tias Verhezen1, Sanne van der Heijden1, Zwi N. Berneman2,3,4, Marc Peeters1,5, Filip Lardon1, An Wouters1† and Evelien L. J. M. Smits1,4† Abstract Immunotherapy is currently under intensive investigation as a potential breakthrough treatment option for glioblastoma. Given the anatomical and immunological complexities surrounding glioblastoma, lymphocytes that infiltrate the brain to develop durable immunity with memory will be key. Polyinosinic:polycytidylic acid, or poly(I:C), and its derivative poly-ICLC could serve as a priming or boosting therapy to unleash lymphocytes and other factors in the (immuno)therapeutic armory against glioblastoma. Here, we present a systematic review on the effects and efficacy of poly(I:C)/poly-ICLC for glioblastoma treatment, ranging from preclinical work on cellular and murine glioblastoma models to reported and ongoing clinical studies. MEDLINE was searched until 15 May 2021 to identify preclinical (glioblastoma cells, murine models) and clinical studies that investigated poly(I:C) or poly-ICLC in glioblastoma. A systematic review approach was conducted according to PRISMA guidelines. ClinicalTrials.gov was queried for ongoing clinical studies. Direct pro-tumorigenic effects of poly(I:C) on glioblastoma cells have not been described. On the contrary, poly(I:C) changes the immunological profile of glioblastoma cells and can also kill them directly. In murine glioblastoma models, poly(I:C) has shown therapeutic relevance as an adjuvant therapy to several treatment modalities, including vaccination and immune checkpoint blockade.
    [Show full text]
  • Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
    MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01
    [Show full text]
  • IFN-Γ- and IL-17-Producing CD8+ T (Tc17-1)
    Open access Short report J Immunother Cancer: first published as 10.1136/jitc-2021-002426 on 30 June 2021. Downloaded from IFN-γ- and IL-17- producing CD8+ T (Tc17-1) cells in combination with poly- ICLC and peptide vaccine exhibit antiglioma activity Takayuki Ohkuri,1,2 Akemi Kosaka,1,2 Maki Ikeura,2 Andres M Salazar,3 1,2,4,5 Hideho Okada To cite: Ohkuri T, Kosaka A, ABSTRACT led to Food and Drug Administration Ikeura M, et al. IFN-γ- and IL- Background While adoptive transfer of T- cells has been approvals for patients with B- cell malig- 17- producing CD8+ T (Tc17-1) a major medical breakthrough for patients with B cell nancies. However, the development of cells in combination with poly- malignancies, the development of safe and effective T- ICLC and peptide vaccine exhibit effective T- cell therapies for GBM remains cell- based immunotherapy for central nervous system antiglioma activity. Journal a challenge due to multiple barriers, (CNS) tumors, such as glioblastoma (GBM), still needs to for ImmunoTherapy of Cancer including restricted T- cell homing to GBM overcome multiple challenges, including effective homing 2021;9:e002426. doi:10.1136/ and the antigenic heterogeneity, as we jitc-2021-002426 and persistence of T- cells. Based on previous observations 2 that interleukin (IL)-17-producing T-cells can traffic to the reviewed recently. Especially, the central + nervous system (CNS) has anatomical ► Additional online CNS in autoimmune conditions, we evaluated CD8 T- cells supplemental material is that produce IL-17 and interferon-γ (IFN-γ) (Tc17-1) cells barriers (eg, blood–brain barrier) which 3 published online only.
    [Show full text]
  • BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available
    BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] BMJ Open Pediatric drug utilization in the Western Pacific region: Australia, Japan, South Korea, Hong Kong and Taiwan Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032426 review only Article Type: Research Date Submitted by the 27-Jun-2019 Author: Complete List of Authors: Brauer, Ruth; University College London, Research Department of Practice and Policy, School of Pharmacy Wong, Ian; University College London, Research Department of Practice and Policy, School of Pharmacy; University of Hong Kong, Centre for Safe Medication Practice and Research, Department
    [Show full text]
  • Delineating the Unique Functions of Ifnα and Ifnβ Context Is
    Washington University School of Medicine Digital Commons@Becker Open Access Publications 1-1-2020 Context Is key: Delineating the unique functions of IFNα and IFNβ in disease Lindsey E Fox Marissa C Locke Deborah J Lenschow Follow this and additional works at: https://digitalcommons.wustl.edu/open_access_pubs REVIEW published: 21 December 2020 doi: 10.3389/fimmu.2020.606874 Context Is Key: Delineating the Unique Functions of IFNa and IFNb in Disease Lindsey E. Fox 1†, Marissa C. Locke 1† and Deborah J. Lenschow 1,2* 1 Department of Pathology and Immunology, Washington University School of Medicine, Saint Louis, MO, United States, 2 Department of Medicine, Washington University School of Medicine, Saint Louis, MO, United States Type I interferons (IFNs) are critical effector cytokines of the immune system and were originally known for their important role in protecting against viral infections; however, they have more recently been shown to play protective or detrimental roles in many disease states. Type I IFNs consist of IFNa, IFNb, IFNϵ, IFNk, IFNw, and a few others, and they all signal through a shared receptor to exert a wide range of biological activities, including antiviral, antiproliferative, proapoptotic, and immunomodulatory effects. Though the Edited by: individual type I IFN subtypes possess overlapping functions, there is growing Mark R. Walter, University of Alabama at Birmingham, appreciation that they also have unique properties. In this review, we summarize some United States of the mechanisms underlying differential expression of and signaling by type I IFNs, and Reviewed by: we discuss examples of differential functions of IFNa and IFNb in models of infectious ´ Gilles Uze, disease, cancer, and autoimmunity.
    [Show full text]
  • Orphan Drug Designation List
    Orphan Drug Designations and Approvals List as of 09‐01‐2015 Governs October 1, 2015 ‐ December 31, 2015 Row Contact Generic Name Trade Name Designation Date Designation Num Company/Sponsor 1 (‐)‐(3aR,4S,7aR)‐4‐Hydroxy‐4‐ m‐tolylethynyl‐octahydro‐ Novartis indole‐1‐carboxylic acid Pharmaceuticals methyl ester n/a 10/12/2011 Treatment of Fragile X syndrome Corp. 2 (1‐methyl‐2‐nitro‐1H‐ imidazole‐5‐yl)methyl N,N'‐ bis(2‐broethyl) diamidophosphate n/a 6/5/2013 Treatment of pancreatic cancer EMD Serono 3 (1‐methyl‐2‐nitro‐1H‐ imidazole‐5‐yl)methyl N,N'‐ bis(2‐bromoethyl) Threshold diamidophosphate n/a 3/9/2012 Treatment of soft tissue sarcoma Pharmaceuticals, Inc. 4 (1OR)‐7‐amino‐12‐fluoro‐ 2,10,16‐trimethyl‐15 oxo‐ 10,15,16,17‐tetrahydro‐2H‐8,4‐ Treatment of anaplastic (metheno)pyrazolo[4,3‐ lymphoma kinase (ALK)‐positive h][2,5,11]benzoxadiazacyclote or ROS1‐positive non‐small cell tradecine‐3‐carbonitrile n/a 6/23/2015 lung cancer Pfizer, Inc. 5 (1R,3R,4R,5S)‐3‐O‐[2‐O‐ Treatment of vaso‐occlusive benzoyl‐3‐O‐(sodium(2S)‐3‐ crisis in patients with sickle cell cyclohexyl‐propanoate‐ n/a 2/17/2009 disease. Pfizer, Inc. 6 (1S)‐1‐(9‐deazahypoxanthin‐9‐ yl)‐1,4‐dideoxy‐1,4‐imino‐D‐ Treatment of acute Mundipharma ribitol‐hydrochloride n/a 8/13/2004 lymphoblastic leukemia Research Limited Page 1 of 359 Orphan Drug Designations and Approvals List as of 09‐01‐2015 Governs October 1, 2015 ‐ December 31, 2015 Row Contact Generic Name Trade Name Designation Date Designation Num Company/Sponsor 7 Treatment of chronic lymphocytic leukemia and related leukemias to include (1S)‐1‐(9‐deazahypoxanthin‐9‐ prolymphocytic leukemia, adult T‐ yl)‐1,4‐dideoxy‐1,4‐imino‐D‐ cell leukemia, and hairy cell Mundipharma ribitol‐hydrochloride n/a 8/10/2004 leukemia Research Ltd.
    [Show full text]
  • © Springer Nature Switzerland AG 2019 D. J. A. Crommelin Et Al. (Eds
    Index A Antibiotic agents, 75 Abatacept, 557, 586, 590 Antibody dependent cellular cytotoxicity (ADCC), 30, 160, 604 Absorption, 167–168 Antibody-dependent cellular phagocytosis (ADCP), 160 Absorption, distribution, metabolism, elimination (ADME), 361 Antibody-drug conjugates (ADCs), 166, 489, 501 Absorption rate-limited kinetics, 441 Antibody fragments, 151 Accelerated degradation, 86 Antibody-mediated cytotoxicity, 544 Acceptable Operating Ranges, 79 Antibody-mediated rejection (AMR), 537, 547, 548 Acellular pertussis vaccines, 293 Antibody pharmacodynamics, 151 Actimmune®, 633 Antibody pharmacokinetics, 166–180 Active pharmaceutical ingredient (API), 83 Antibody structure, 151, 158–162 Actual wholesale price (AWP), 550 Anti-CD19, 371 Acute rejection, 544, 550 Anti CD20 antibodies, 491–498 Adalimumab, 557, 585 Anti CTLA4 antibodies, 512 Adaptive immune response, 285 Anti-drug antibodies (ADAs), 139, 159 Adaptive immune system, 281, 370 Anti-EGFR, 502–507 Adeno associated virus (AAV), 370 Anti-EGFR-strategies, 502–507 Adenosine deaminase severe combined immunodeficiency Anti-fibrotic, 368 disease (ADA SCID), 370 Antigen-presenting cells (APCs), 286 Adenovirus (Ad), 292, 370 Antigen processing, 287 Adipocytes, 365 Anti growth factor receptor antibodies, 502–504 Adjuvants, 286 Anti growth factor receptor antibodies anti-EGFR2, 507–508 Ado-Trastuzumab-/Trastuzumab Emtanside, 507 Anti-hGH antibodies, 446 Adsorption, 87, 89, 90 Anti-idiotypic IgE, 544 Adsorption chromatography, 69 Anti-IL-1β, 588 Advanced therapies, 357 Anti-IL-5, 603 Advanced
    [Show full text]
  • The HER2 Peptide Nelipepimut-S (E75) Vaccine (Neuvax™) in Breast Cancer Patients at Risk for Recurrence: Correlation of Immunologic Data with Clinical Response
    Drug Evaluation For reprint orders, please contact: [email protected] HER2 peptide nelipepimut-S (E75) vaccine (NeuVax™) in breast cancer patients at risk for The HER2 peptide nelipepimut-S (E75) vaccine (NeuVax™) in breast cancer patients at risk for recurrence: correlation of immunologic data with clinical response Nelipepimut-S (formerly known as E75) is an immunogenic peptide from the HER2 Erika J Schneble1, John S protein that is highly expressed in breast cancer. The NeuVax™ (Galena, OR, USA) Berry1, Francois A Trappey1, vaccine, nelipepimut-S plus granulocyte–macrophage colony-stimulating factor, is Guy T Clifton1, Sathibalan 2 designed for the prevention of clinical recurrences in high risk, disease-free breast Ponniah , Elizabeth Mittendorf3 & George E cancer patients. Although cancer vaccines such as NeuVax represent promising Peoples*,1 approaches to cancer immunotherapy, much remains to be elucidated regarding their 13AN!NTONIO-ILITARY-EDICAL#ENTER mechanisms of action: particularly given that multiple cancer vaccine trials have failed $EPARTMENTOF'ENERAL3URGERY &ORT to demonstrate a correlation between immunologic data and clinical outcome. Here, 3AM(OUSTON 48 53! we briefly discuss our clinical trial experience with NeuVax focusing on immunologic #ANCER6ACCINE$EVELOPMENT response data and its implication on how the immune system may be affected by this ,ABORATORY 5NIFORMED3ERVICES 5NIVERSITYOFTHE(EALTH3CIENCES peptide vaccine. Most importantly, we demonstrate the potential capability of certain "ETHESDA -$ 53! immunologic assays to predict clinical benefit in our trials. 35NIVERSITYOF4EXAS-$!NDERSON #ANCER#ENTER (OUSTON 48 53! Keywords:BREASTCANCERs%s(%2PEPTIDEVACCINEsIMMUNOTHERAPYsNELIPEPIMUT 3 !UTHORFORCORRESPONDENCE 4EL &AX Background breast cancer patients decreasing recurrence GEORGEPEOPLES HOTMAILCOM The HER2/neu proto-oncogene, a member rates by approximately 50% [6–8].
    [Show full text]