Abstract
Reovirus (Reolysin®) is a viral entity that replicates only in cells expressing an activated Ras pathway, and as such, this virus represents a novel therapy for cancer. In anticipation of systemic application of Reolysin® to humans, this study evaluated the safety of Reolysin® administration (via 15-minute intravenous infusion) to cynomolgus monkeys at daily dose levels of 0, 5.0 × 107, 5.0 × 108, and 5.0 × 109 TCID50 for 28 consecutive days. In-life, monkeys were evaluated for clinical signs of effect, and changes in food consumption, body weight, electrocardiographic and ophthalmic measurements, and serum chemistry, hematology, and coagulation parameters. A subset of monkeys underwent scheduled euthanasia on Day 29, and the remaining monkeys were maintained for an additional treatment-free 28-day period to evaluate reversibility of Reolysin®-related changes. At euthanasia, a full necropsy was conducted on all monkeys, urine samples were obtained via bladder puncture and analyzed, selected organ weights were recorded, and tissues were collected, preserved, processed and examined using light microscopy.
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