Rytelo: how long were the pivotal tox studies?

“Dose and frequency of dosing: 0, 5, 10 or 15 mg/kg for 9 months + 14 weeks recovery; once a week dosing.”

“Additional imetelstat toxicities observed in the chronic pivotal toxicity studies, ie, the 6-month study in mice (003-TOX-2008) and the 9-month study in monkeys, included microscopic findings in the liver and kidney”

“The drug was dosed for 6 months in rats and 9 months in monkeys via IV administration, which is consistent with the intended clinical route of administration.”