Campath: which tox species, and why?

“Single and repeated dose toxicity studies were investigated in cynomolgus monkeys.”

“With respect to cynomolgus monkeys, the CHMP considered that although alemtuzumab was pharmacologically active in the species, the relevance of this species was limited due to species differences in the amino acid sequence for the CD52 antigen.”

“Reproductive and developmental toxicity studies were conducted in the huCD52 transgenic mouse model. This model was characterised in a series of pharmacodynamic studies.”

“Single and repeated dose toxicity studies were investigated in cynomolgus monkeys.”

“Reproductive and developmental toxicity studies were conducted in the huCD52 transgenic mouse model. This model was characterised in a series of pharmacodynamic studies.”

“The CHMP also considered acceptable that no carcinogenicity testing was performed, taking into account the lack of an appropriate animal model, the well-established risk of indirect tumorigenicity caused by prolonged immunosuppression and the previous scientific advice provided by the CHMP.”

“Reproductive and developmental toxicity studies were conducted in the huCD52 transgenic mouse model. This model was characterised in a series of pharmacodynamic studies.”