Simponi: which tox species, and why?

“An overview of the repeat-dose toxicity studies with golimumab in cynomolgus monkeys as well as the supportive study with the murine analogous molecule cV1q is given in Table 1.”

“The cynomolgus monkey was chosen as the most relevant non-clinical species, since golimumab showed little or no neutralization of dog, rabbit, mouse or rat TNFα.”

“Supportive toxicology studies were conducted in mice using the analogous anti-mouse TNFα monoclonal antibody, cV1q, to evaluate the effects of anti-TNFα treatment on reproductive development and chronic toxicity.”

“The cynomolgus monkey was chosen as the most relevant non-clinical species, since golimumab showed little or no neutralization of dog, rabbit, mouse or rat TNFα. For the studies in mice, an analogous anti-mouse TNFα monoclonal antibody designated cV1q, developed during the non-clinical testing of another TNFα inhibitor, infliximab (Remicade), was used.”

“Reproductive toxicity was evaluated both in cynomolgus monkeys and in CD-1 mice, using the analogous mouse anti-TNFα antibody cV1q.”

“No carcinogenicity study was performed with golimumab as standard rodent studies are not meaningful due to lack of pharmacologic activity in this species.”

“Supportive toxicology studies were conducted in mice using the analogous anti-mouse TNFα monoclonal antibody, cV1q, to evaluate the effects of anti￾TNFα treatment on reproductive development and chronic toxicity.”