Preclinical safety evaluation of monoclonal antibodies

Handbook of Experimental Pharmacology

Volumn 181, Issue , 2008, Pages 19-44

  Lynch, C M ^a   Grewal, I S ^a  

^a SEATTLE GENETICS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ANIMAL; DRUG SCREENING; HUMAN; IMMUNOTHERAPY; METHODOLOGY; PRACTICE GUIDELINE; PROGRAM DEVELOPMENT; REVIEW; TOXICITY TESTING;

ANIMALS; ANTIBODIES, MONOCLONAL; DRUG EVALUATION, PRECLINICAL; GUIDELINES AS TOPIC; HUMANS; IMMUNOTHERAPY; PROGRAM DEVELOPMENT; RECOMBINANT PROTEINS; TOXICITY TESTS;

EID: 38449088134     PISSN: 01712004     EISSN: 18650325     Source Type: Book Series    
DOI: 10.1007/978-3-540-73259-4_2     Document Type: Article

References (24)

1. Adams GP and Weiner LM (2005) Monoclonal antibody therapy of cancer. Nat Biotechnol 23:1147-1157
2. Berger J.R. (2006a) Natalizumab and progressive multifocal leucoencephalopathy. Ann Rheum Dis 65:iii48-iii53
3. Berger J.R. (2006b) Natalizumab. Drugs Today 42:639-655
4. Berger J.R. and Koralnik IJ (2005) Progressive multifocal leukoencephalopathy and natalizumab- unforeseen consequences. N Engl J Med 353:414-416
5. Berger J.R. Racher AJ (2006) Antibody production. Adv Drug Deliv Rev 58:671-85
6. Byrd JC et al. (1999) Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: association with increased infusion-related side effects and rapid blood tumor clearance. J Clin Oncol 17: 791-795
7. Carson KL (2005) Flexibility-the guiding principle for antibody manufacturing. Nat Biotechnol 23:1054-1058
8. Carter PJ (2006) Potent antibody therapeutics by design. Nat Rev Immunol 6:343-357
9. Chapman K et al. (2007) Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat Rev Drug Discov 6:120-6.
10. Herbst RS and Langer CJ (2002) Epidermal growth factor receptors as a target for cancer treatment: the emerging role of IMC-C225 in the treatment of lung and head and neck cancers. Semin Oncol 29:27-36
11. Hurwitz H et al. (2004) Bevacizumab plus irinotecan fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342
12. Hoogenboom HR (2005) Selecting and screening recombinant antibody libraries. Nat Biotechnol 23:1105-1116
13. Kim SJ et al. (2005) Antibody engineering for the development of therapeutic antibodies. Mol Cells 20:17-29
14. Kimby E (2005) Tolerability and safety of rituximab (MabThera). Cancer Treat Rev 31:456-73
15. Lonberg N (2005) Human antibodies from transgenic animals. Nat Biotechnol 23:1117-1125
16. Phan GQ et al. (2003) Cancer regression and autoimmunity induced by cytotoxic T lymphocyteassociated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci USA 100:8372-8377
17. Reichert JM et al. (2005) Monoclonal antibody successes in the clinic. Nat Biotechnol 23:1073-1078
18. Robert F et al. (2001) Phase I study of anti-epidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. J Clin Oncol 19(13):3234-3243
19. Roy D and Andrews PA (2004) Nonclinical testing from theory to practice. In: Teicher BA and Andrews PA (eds), Anticancer drug development guide, 2nd edn, Humana Press, Totowa, NJ, pp 287-311
20. Scott CT (2005) The problem with potency. Nat Biotechnol 23:1037-1039
21. Siegel EB (2004) The Pre-Pre-IND FDA consultation process for preclinical studies: opportunities for launching a rapid drug or biologic development program. Preclinica 2:171
22. Sidiropoulos PI and Boumpas DT (2004) Lessons learned from anti-CD40L treatment in systemic lupus erythematosus patients. Lupus 13:391-397
23. Slamon DJ et al. (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783-792
24. Suntharalingam G et al. (2006) Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 355:1018-1028