Literature DB >> 18190459

Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412.

C M Dayan1, D C Wraith.   

Abstract

Current immunology research is generating many new approaches to immunotherapy. However, the recent disaster surrounding the testing of TGN1412, has unsettled regulators and the pharmaceutical industry regarding new immunotherapies and highlighted the complexities of conducting clinical trials with agents that target the immune system. Here we discuss the critical role for immunologists in ensuring that the development of new immunotherapies continues.

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Year:  2008        PMID： 18190459      PMCID： PMC2276942          DOI： 10.1111/j.1365-2249.2007.03559.x

Source DB:  PubMed          Journal:  Clin Exp Immunol        ISSN： 0009-9104            Impact factor:   4.330


  9 in total

1.  Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412.

Authors:  Ganesh Suntharalingam; Meghan R Perry; Stephen Ward; Stephen J Brett; Andrew Castello-Cortes; Michael D Brunner; Nicki Panoskaltsis
Journal:  N Engl J Med       Date:  2006-08-14       Impact factor: 91.245

Review 2.  Establishing risk of human experimentation with drugs: lessons from TGN1412.

Authors:  M J H Kenter; A F Cohen
Journal:  Lancet       Date:  2006-10-14       Impact factor: 79.321

3.  "We saw human guinea pigs explode".

Authors:  L Stobbart; M J Murtagh; T Rapley; G A Ford; S J Louw; H Rodgers
Journal:  BMJ       Date:  2007-03-17

4.  A personal perspective on the Royal Statistical Society report of the working party on statistical issues in first-in-man studies.

Authors:  Steven Julious
Journal:  Pharm Stat       Date:  2007 Apr-Jun       Impact factor: 1.894

5.  Critics pan timid European response to TeGenero disaster.

Authors:  Peter Mitchell
Journal:  Nat Biotechnol       Date:  2007-04-30       Impact factor: 54.908

6.  Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes.

Authors:  Bart Keymeulen; Evy Vandemeulebroucke; Anette G Ziegler; Chantal Mathieu; Leonard Kaufman; Geoff Hale; Frans Gorus; Michel Goldman; Markus Walter; Sophie Candon; Liliane Schandene; Laurent Crenier; Christophe De Block; Jean-Marie Seigneurin; Pieter De Pauw; Denis Pierard; Ilse Weets; Peppy Rebello; Pru Bird; Eleanor Berrie; Mark Frewin; Herman Waldmann; Jean-François Bach; Daniel Pipeleers; Lucienne Chatenoud
Journal:  N Engl J Med       Date:  2005-06-23       Impact factor: 91.245

7.  The Northwick Park tragedy--protecting healthy volunteers in future first-in-man trials.

Authors:  T Dowsing; M J Kendall
Journal:  J Clin Pharm Ther       Date:  2007-06       Impact factor: 2.512

8.  Some aspects of the recombinantly expressed humanised superagonist anti-CD28 mAb, TGN1412 trial catastrophe lessons to safeguard mAbs and vaccine trials.

Authors:  Jitendra N Mehrishi; Miklós Szabó; Tibor Bakács
Journal:  Vaccine       Date:  2007-03-15       Impact factor: 3.641

9.  Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy.

Authors:  Tarek A Yousry; Eugene O Major; Caroline Ryschkewitsch; Gary Fahle; Steven Fischer; Jean Hou; Blanche Curfman; Katherine Miszkiel; Nicole Mueller-Lenke; Esther Sanchez; Frederik Barkhof; Ernst-Wilhelm Radue; Hans R Jäger; David B Clifford
Journal:  N Engl J Med       Date:  2006-03-02       Impact factor: 91.245
  9 in total
  10 in total

Review 1.  The safety and side effects of monoclonal antibodies.

Authors:  Trevor T Hansel; Harald Kropshofer; Thomas Singer; Jane A Mitchell; Andrew J T George
Journal:  Nat Rev Drug Discov       Date:  2010-03-22       Impact factor: 84.694

2.  Development of Cancer Immunotherapies.

Authors:  Diana C DeLucia; John K Lee
Journal:  Cancer Treat Res       Date:  2022

Review 3.  Establishing humanized mice using stem cells: maximizing the potential.

Authors:  D Bernard; M Peakman; A C Hayday
Journal:  Clin Exp Immunol       Date:  2008-04-24       Impact factor: 4.330

4.  A FIM study to assess safety and exposure of inhaled single doses of AP301-A specific ENaC channel activator for the treatment of acute lung injury.

Authors:  Richard Schwameis; Sandra Eder; Helmut Pietschmann; Bernhard Fischer; Hermann Mascher; Susan Tzotzos; Hendrik Fischer; Rudolf Lucas; Markus Zeitlinger; Robert Hermann
Journal:  J Clin Pharmacol       Date:  2014-03       Impact factor: 3.126

Review 5.  Lessons learnt from many years of experience using anti-D in humans for prevention of RhD immunization and haemolytic disease of the fetus and newborn.

Authors:  B M Kumpel
Journal:  Clin Exp Immunol       Date:  2008-08-22       Impact factor: 4.330

6.  Participation of hypertension patients in early-phase clinical trials.

Authors:  Paul Borron; Oren Cohen; Theo J Hoofwijk; J Rick Turner
Journal:  J Clin Hypertens (Greenwich)       Date:  2014-04-22       Impact factor: 3.738

Review 7.  The Nuremberg Code subverts human health and safety by requiring animal modeling.

Authors:  Ray Greek; Annalea Pippus; Lawrence A Hansen
Journal:  BMC Med Ethics       Date:  2012-07-08       Impact factor: 2.652

8.  TGN1412: From Discovery to Disaster.

Authors:  H Attarwala
Journal:  J Young Pharm       Date:  2010-07

9.  The protein kinase C agonist PEP005 (ingenol 3-angelate) in the treatment of human cancer: a balance between efficacy and toxicity.

Authors:  Elisabeth Ersvaer; Astrid Olsnes Kittang; Peter Hampson; Kristoffer Sand; Bjørn Tore Gjertsen; Janet M Lord; Oystein Bruserud
Journal:  Toxins (Basel)       Date:  2010-01-22       Impact factor: 4.546

10.  The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries.

Authors:  Lydia Kapiriri; James V Lavery; Peter A Singer; Hassan Mshinda; Lorne Babiuk; Abdallah S Daar
Journal:  BMC Public Health       Date:  2011-10-18       Impact factor: 3.295
  10 in total

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