Simulect: which tox species, and why?

“Apart from the studies performed in primates, no toxicity studies in rodents or non-rodent animals except primates could have been carried out because of the species specificity of the antibody.”

“Simulect bound specifically to the α-chain of the primate IL-2-receptor, but not to the dog IL-2 receptor.”

“Apart from the studies performed in primates, no toxicity studies in rodents or non-rodent animals except primates could have been carried out because of the species specificity of the antibody.”

“Repeated dose toxicity study has been performed in monkeys (4 weeks intravenous in the rhesus monkey with an 8 week treatment, doses at 0.5 to 4.5 mg/kg every 4th day).”

“No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgus monkeys 100 days post coitum following dosing with basiliximab during the organogenesis period; blood levels in pregnant monkeys were 13-fold higher than those seen in human patients.”

“No long-term or fertility studies in laboratory animals have been performed to evaluate the potential of Simulect to produce carcinogenicity or fertility impairment, respectively.”

“Apart from the studies performed in primates, no toxicity studies in rodents or non-rodent animals except primates could have been carried out because of the species specificity of the antibody.”