Ziihera: how long were the pivotal tox studies?

“A comprehensive series of non-GLP and GLP studies have been conducted. The program included tissue cross-reactivity studies in panels of human tissues and IV toxicology studies of up to 13 treatment cycles (13 weeks duration) performed in cynomolgus monkeys.”

“Doses of 0 (vehicle control), 5, 50, and 150 mg/kg QW Route of administration: 1 hour IV infusion Formulation/Vehicle: sucrose, pH Species/Strain: Cynomolgus monkey”

“Intravenous dosing was utilized in all pivotal toxicology studies since it is the intended route of administration in the clinic.”