Cimzia: genotox, carcinogenicity and repro: done or skipped?

“Certolizumab pegol was not genotoxic in the Ames test, the human peripheral blood lymphocytes chromosomal aberration assay, or the mouse bone marrow micronucleus assay.”

“No conventional carcinogenicity testing was performed with certolizumab pegol, which was acceptable considering the nature of the compound and the lack of pharmacological activity and immunogenicity of certolizumab pegol in species normally used for such testing.”

“In female rat studies covering dosing throughout the complete reproductive cycle, there were no effects on fertility, reproductive function or developmental effects on offspring.”

“No in vivo safety pharmacology studies have been conducted with certolizumab pegol, however monitoring of potential undesirable pharmacological activity was incorporated in both the repeat dose toxicity studies and single dose Phase 1 clinical studies.”