Arzerra: how long were the pivotal tox studies?

“populations of NK cells, which are central to immune surveillance, did not change during pivotal repeat dose studies of up to 7 months duration.”

“some safety pharmacology end points, such as cardiovascular and renal parameters and body temperature, were evaluated as part of the pivotal 4 week and 7 month repeat dose toxicity studies in cynomolgus monkeys.”

“The majority of studies were performed by the IV route (infusion over 30 minutes) as this is the clinical route of administration; however, the SC route of administration was also examined in a single study.”