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A Single-Dose Toxicology Study of NP2 Administered Subcutaneously in BALB/c Mice with 90 Day Follow-up

Study Summary

Overall Study Design 
The objective of this study was to evaluate the toxicity of recombinant viral test article NP2 following subcutaneous injection 
of BALBcAnN Sim fBR mice Justification for use Mice are an accepted species frequently used in pre-clinical evaluation of 
drugs and biologicals intended for human use The test article was NP2 a replication-defective herpes simplex virus-based 
viral vector engineered to express the human preproenkephalin produced by the Human Gene Therapy Applications 
Laboratory HGTAL of the University of Pittsburgh A single lot number 20050805 was used for the study The study 
consisted of 4 groups of 80 mice 40 male 40 female each all dosed subcutaneously SC on Study Day 0 
Group 1 received a single dose of PBS SC Groups 2-4 were injected SC with NP2 see table above Animals 10 
micesexgrouptimepoint were sacrificed on Days 1 7 28 and 91 ie one day one week four weeks and three months 
post-dosing In practice the study was divided into 4 cohorts each corresponding to one of the sacrifice periods Thus 
there was a 1-day cohort a 7-day cohort a 28-day cohort and a 91-day cohort 
Throughout the in-life phase animals were checked once daily for mortality and morbidity Body weights were measured 
prior to dosing and weekly thereafter and food consumption was measured weekly Blood was collected from each animal 
at the time of sacrifice for hematology and clinical chemistry Complete necropsies were performed on each animal at 
sacrifice including selected organ weights as specified in the protocol A full list of tissues were fixed and processed for 
histopathological analysis 
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