Campath: how long were the pivotal tox studies?

“In a previous CHMP scientific advice, the 30-day toxicity testing was considered sufficient to cover the clinical schedule for alemtuzumab treatment, i.e. administration on 5 consecutive days followed by administration on 3 consecutive days after one year.”

“Two repeat dose studies were conducted in cynomolgus monkeys.”

“Alemtuzumab was investigated in 3 single dose toxicity studies in cynomolgus monkeys, using both i.v. and s.c. administrations of alemtuzumab at dose levels ranging from 0.1 to 30 mg/kg.”