Report Summary

60-Day Subcutaneous Toxicity Study of Recombinant Adenovirus Expressing PDGF-B in C57B1/6 Mice

Study Summary

Overall Study Design 
The purpose of this study was to assess potential toxicity of an E1E3-deleted replication incompetent human type 5 
adenovirus expressing the human platelet-derived growth factory beta abbreviated PDGF-B gene following subcutaneous 
administration in C57B16 mice 
Single subcutaneous doses of the nonreplicative adenoviral vector H5020CMVPDGF-B were injected on Day 1 into 
groups of C57B16 mice 18 micesexgroup Mice were assigned to one of three treatment groups 108 109 1010 
viral particlesdose or to one vehicle saline control group Cinical pathology and histopathology data were collected from 6 
micesexgroup at each necropsy Days 4 11 and 60 Mortality clinical observations weekly body weights and terminal 
organ weights were also recorded 
indicate any sign of test article related toxicity through Day 60 

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