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Developmental Toxicity Assessment of Tanezumab, an Anti-Nerve Growth Factor Monoclonal Antibody, in Cynomolgus Monkeys (Macaca fascicularis).
MedLine Citation:
PMID:  25461901     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Two intravenous studies with tanezumab, an anti- nerve growth factor monoclonal antibody, were conducted in pregnant cynomolgus monkeys to assess potential effects on pregnancy and pre- and postnatal development. Study 1 evaluated infants up to 12 months of age following weekly maternal dosing (0, 0.5, 4 or 30mg/kg; 18 per group) from gestation day (GD) 20 through parturition. Study 2 evaluated infants 2 months postnatally following weekly maternal dosing (0, 0.5 or 30mg/kg; 20-21 per group) from GD 20 through 48. In the absence of maternal toxicity, tanezumab increased stillbirth and post-birth infant mortality/morbidity, decreased infant growth and resulted in microscopic changes in the peripheral sympathetic and sensory nervous system of the infants at all doses. Decreased primary antibody responses and increased incidences in skin changes in infants were also observed. The no-observed-adverse-effect-level for maternal toxicity was 30mg/kg and <0.5mg/kg for developmental toxicity.
Authors:
Christopher J Bowman; Mark Evans; Thomas Cummings; Satoru Oneda; Mark Butt; Susan Hurst; Jessica-Lyn Gremminger; David Shelton; Cris Kamperschroer; Mark Zorbas
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-10-14
Journal Detail:
Title:  Reproductive toxicology (Elmsford, N.Y.)     Volume:  -     ISSN:  1873-1708     ISO Abbreviation:  Reprod. Toxicol.     Publication Date:  2014 Oct 
Date Detail:
Created Date:  2014-12-2     Completed Date:  -     Revised Date:  2014-12-3    
Medline Journal Info:
Nlm Unique ID:  8803591     Medline TA:  Reprod Toxicol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014. Published by Elsevier Inc.
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