Tysabri: which tox species, and why?

“Two cross-reactive species, the cynomolgus monkey and guinea pigs were used to”

“The following species are reacting with the antibody: Rhesus and cynomolgus monkey, pig, ferret, guinea pig, and dog. Lymphocytes from rat, gerbil, hamster, rabbit, or marmoset monkey are not reactive.”

“Standard but pharmacologically irrelevant, rodent species were not evaluated.”

“Chronic toxicity studies of repeated doses of natalizumab over a 26-week period, followed by a 17 week dose-free period in cynomolgus monkeys”

“Studies addressing fertility and early embryonic development were performed in guinea pigs.”

“Two in vitro and three in vivo studies were performed to study the effects the natalizumab on human α 4 expressing tumour cell lines in vitro and in vivo (as transplants into SCID and nude mice).”

“Standard but pharmacologically irrelevant, rodent species were not evaluated.”