Faculty Opinions recommendation of Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725618825.793517604 ◽

2016 ◽

Author(s):

Keith Davis

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Phase I ◽

Transgenic Tobacco ◽

Regulatory Approval ◽

Phase I Clinical Trial ◽

Transgenic Tobacco Plants ◽

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Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants

Plant Biotechnology Journal ◽

10.1111/pbi.12416 ◽

2015 ◽

Vol 13 (8) ◽

pp. 1106-1120 ◽

Author(s):

Julian K-C. Ma ◽

Jürgen Drossard ◽

David Lewis ◽

Friedrich Altmann ◽

Julia Boyle ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Phase I ◽

Transgenic Tobacco ◽

Regulatory Approval ◽

Phase I Clinical Trial ◽

Transgenic Tobacco Plants ◽

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A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults

Expert Opinion on Investigational Drugs ◽

10.1080/13543784.2020.1770226 ◽

2020 ◽

Vol 29 (7) ◽

pp. 755-762

Author(s):

Jiaxue Wang ◽

Suping Niu ◽

Wenliang Dong ◽

Li Wei ◽

Lun Ou ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Phase I ◽

Phase I Clinical Trial ◽

Chinese Adults ◽

Healthy Chinese

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Correction for Scott et al., A phase I clinical trial with monoclonal antibody ch806 targeting transitional state and mutant epidermal growth factor receptors

Proceedings of the National Academy of Sciences ◽

10.1073/pnas.0708144104 ◽

2007 ◽

Vol 104 (40) ◽

pp. 15965-15965 ◽

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Growth Factor ◽

Epidermal Growth Factor ◽

Phase I ◽

Growth Factor Receptors ◽

Phase I Clinical Trial ◽

Epidermal Growth Factor Receptors ◽

Transitional State ◽

Epidermal Growth

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From gene to harvest: insights into upstream process development for the GMP production of a monoclonal antibody in transgenic tobacco plants

Plant Biotechnology Journal ◽

10.1111/pbi.12438 ◽

2015 ◽

Vol 13 (8) ◽

pp. 1094-1105 ◽

Author(s):

Markus Sack ◽

Thomas Rademacher ◽

Holger Spiegel ◽

Alexander Boes ◽

Stephan Hellwig ◽

...

Keyword(s):

Monoclonal Antibody ◽

Transgenic Tobacco ◽

Process Development ◽

Transgenic Tobacco Plants ◽

Tobacco Plants ◽

Upstream Process ◽

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A phase I clinical trial with monoclonal antibody ch806 targeting transitional state and mutant epidermal growth factor receptors

Proceedings of the National Academy of Sciences ◽

10.1073/pnas.0611693104 ◽

2007 ◽

Vol 104 (10) ◽

pp. 4071-4076 ◽

Author(s):

A. M. Scott ◽

F.-T. Lee ◽

N. Tebbutt ◽

R. Herbertson ◽

S. S. Gill ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Growth Factor ◽

Epidermal Growth Factor ◽

Phase I ◽

Growth Factor Receptors ◽

Phase I Clinical Trial ◽

Epidermal Growth Factor Receptors ◽

Transitional State ◽

Epidermal Growth

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Recovery and isolation of recombinant human monoclonal antibody from transgenic tobacco plants

Biochemical Engineering Journal ◽

10.1016/j.bej.2011.02.004 ◽

2011 ◽

Vol 54 (2) ◽

pp. 103-108 ◽

Author(s):

Mukesh Mayani ◽

Michael D. McLean ◽

J. Christopher Hall ◽

Carlos D.M. Filipe ◽

Raja Ghosh

Keyword(s):

Monoclonal Antibody ◽

Transgenic Tobacco ◽

Human Monoclonal Antibody ◽

Transgenic Tobacco Plants ◽

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PHASE-I CLINICAL TRIAL OF MONOCLONAL ANTIBODY IN TREATMENT OF GASTROINTESTINAL TUMOURS

10.1016/s0140-6736(82)91811-6 ◽

1982 ◽

Vol 319 (8275) ◽

pp. 762-765 ◽

Author(s):

HenryF. Sears ◽

Jeffrey Mattis ◽

Dorothee Herlyn ◽

Pekka Häyry ◽

Barbara Atkinson ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Phase I ◽

Phase I Clinical Trial ◽

Gastrointestinal Tumours

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Preclinical and phase I clinical trial of blockade of IL-15 using Mik 1 monoclonal antibody in T cell large granular lymphocyte leukemia

Proceedings of the National Academy of Sciences ◽

10.1073/pnas.0509575103 ◽

2005 ◽

Vol 103 (2) ◽

pp. 401-406 ◽

Author(s):

J. C. Morris ◽

J. E. Janik ◽

J. D. White ◽

T. A. Fleisher ◽

M. Brown ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

T Cell ◽

Phase I ◽

Phase I Clinical Trial ◽

Large Granular Lymphocyte ◽

Large Granular Lymphocyte Leukemia

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Evidence of immunogenicity with the anti-idiotypic monoclonal antibody vaccine 1E10. Results from a phase I clinical trial in breast cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2005.23.16_suppl.2561 ◽

2005 ◽

Vol 23 (16_suppl) ◽

pp. 2561-2561

Author(s):

M. A. Castro ◽

M. Guthmann ◽

G. Cinat ◽

C. Venier ◽

R. Bitton ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Monoclonal Antibody ◽

Phase I ◽

Cancer Patients ◽

Phase I Clinical Trial ◽

Breast Cancer Patients

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30 A phase I clinical trial of HGS-ETR1, an agonist monoclonal antibody to TRAIL-R1, in patients with advanced solid tumors

European Journal of Cancer Supplements ◽

10.1016/s1359-6349(04)80038-7 ◽

2004 ◽

Vol 2 (8) ◽

pp. 13 ◽

Author(s):

R.B. Cohen ◽

N.J. Meropol ◽

K.M. Padavic ◽

N.L. Fox ◽

A. Corey ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Phase I ◽

Solid Tumors ◽

Phase I Clinical Trial ◽

Advanced Solid Tumors

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