Xolair: which tox species, and why?

“Two pivotal repeated-dose toxicity studies were performed in Cynomolgus monkeys”

“The Cynomolgus monkey was chosen as model to predict human pharmacology and toxicology since omalizumab binds Cynomolgus and human IgE with similar affinity but does not bind non-primate IgE.”

“Rodent asthma models were not considered because of the species specificity of omalizumab and because there were no appropriate non-anaphylactogenic surrogate antibodies available for evaluation in rodent models.”