Bacterial infections in cynomolgus monkeys given small molecule immunomodulatory antagonists

Journal of Immunotoxicology
Karen D Price

Abstract

Opportunistic infections (OIs) during the course of non-clinical toxicity studies can serve as a clinical indicator of immunosuppression. In monkeys, severity may be magnified since the possibility for fecal-oral and cage-to-cage transmission of bacteria exists, reserve capacity is low, and clinical signs of infection are not easily detected until the infectious process is well underway. This review summarizes a case study presented at the HESI-ILSI ITC-Sponsored workshop on Naturally Occurring Infections in Non-human Primates and Immunotoxicity Implications. It gives an overview on the impact of bacterial infections in monkeys on the development and regulatory assessment of three closely-related representative small molecule immunomodulatory (anti-inflammatory) drug candidates all inhibiting the same drug target. The infections, which sometimes progressed to bacteremia and death, originally manifested in the skin, upper respiratory tract, gastrointestinal tract, and less frequently as soft tissue abscesses. Infections were sporadic and not observed in all studies despite coverage of equivalent or higher systemic exposures or longer durations of treatment. To address concerns regarding inconsistency in the presentation and type...Continue Reading

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Citations

Oct 28, 2010·Molecular Microbiology·Anna Staroń, Thorsten Mascher
Nov 2, 2014·Veterinary Clinical Pathology·M C M Parrula, D Pandya
Jul 30, 2015·Regulatory Toxicology and Pharmacology : RTP·Frank R BrennanLucinda Weir
Sep 3, 2020·Toxicologic Pathology·Thierry D FlandreMaurice G Cary

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