Report Summary

Evaluation of Potential Toxicity of Electroporation Mediated Delivery of a Plasmid Encoding for IL-12 in a Mouse Melanoma Model

Study Summary

Overall Study Design 
Previous reports from our laboratory have shown that intra-tumor injection of a plasmid encoding IL-12 pIL-12 followed by 
electroporation results in an 80 cure rate of established B16F10 tumors in mice Twelve of twelve cured mice were 
resistant to subsequent challenge with B16F10 cells In addition intra-muscular injection of plasmid encoding IL-12 
followed by electroporation significantly reduced the formation of lung colonies following intravenous injection of B16F10 
cells These pre-clinical studies demonstrated the therapeutic potential of this approach To translate this to the clinic the 
following study was conducted to evaluate the potential toxicity of plasmid delivery with electroporation Mice were divided 
into 5 groups intratumor injection of saline Group 1 or injections of plasmid at 01 mgml Groups 2 3 or 1mgml Groups 
4 5 with or without electroporation The plasmid 50 l was injected directly into the tumor and immediately followed by 
electroporation Treatments were administered on days 1 5 and 8 Each mouse was monitored for body weight and 
general condition on a daily basis beginning the day prior to the first treatment On days 9 11 16 23 and 30 after 
treatment 10 mice from each group 5 male and 5 female were euthanized Blood was collected from each animal and 
used to perform serum chemistries and CBCs In addition liver lung lymph node tumor skin heart kidney spleen and 
brain samples were collected and histologically analyzed in mice from Groups 1 4 and 5 
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