Target Animal Safety Study of Cisplatin Beads in Horses (INADA 10-829)

Royer Biomedical, Inc., Frederick MD

Investigators

Abstract

Project Summary ? Target Animal Safety Study for Cisplatin Implantable Beads The objective of this study is to determine the safety and toxicity of treatment with cisplatin impregnated, slow release implantable beads in horses. The beads are being developed as a treatment for sarcoids in equidae. Twelve horses of non-specific gender, age and breed will be utilized in the study. The study horses will be examined prior to bead implantation to ensure that they are systemically healthy. This will be determined by physical examination, serum chemistry analysis, complete blood cell count, and urinalysis with GGT/creatinine ratio. On Day 0, horses will be implanted with 15 cisplatin-impregnated beads, under the skin on the lateral side of the neck. Horses will subsequently be monitored by blood chemistry analysis, urinalysis, intermittent physical examination, and daily observation of health status over 35 days. Blood samples will be collected on Day 0, 7 14, 21, 28 and 35 for clinical chemistry and complete blood cell count. Horses will be evaluated clinically for their reaction to the dose and delivery form through daily clinical observation and physical exam at 0, 7, 14, 21, 28 and 35 days following dosing on Day 0. Urine will be collected on study Days 0, 7, 14, 21, 28, and 35 for routine urinalysis and determination of urine GGT/creatinine ratio.