Mylotarg: how long were the pivotal tox studies?

“A GLP-compliant general toxicity study in monkeys was also completed in which 12 doses of gemtuzumab ozogamicin were given once weekly by intravenous bolus injection to groups of 3 male and 3 female cynomolgus monkeys at doses of 0 (sterile water), 2.2, 6.6, or 11 mg/m2 /week.”

“Rats were administered 6 weekly doses at 0 (PBS control), 7.2 (hP67.6 antibody control), or CL 555,201 (GO) at doses of 0.6, 2.4, or 7.2 mg/m2 /week and observed for an additional 4 weeks.”

“Monkeys were administered 6 weekly IV doses at 0 (PBS control), 22 (hP67.6 antibody control), or CL 555,201 at doses of 2.4, 7.2, or 22 mg/m2 /week (5, 15 or 45 mcg/kg/week calicheamicin equivalents) and observed for an additional 4 weeks.”