Report Summary

Single Dose Subcutaneous Biodistribution Study of Recombinant Adenovirus Expressing PDGF-B in C57B1/6 Mice

Study Summary

Overall Study Design 
The purpose of this study was to assess biologic distribution of an E1E3 deleted replication-incompetent human type 5 
adenovirus expressing the human platelet-derived growth factor beta PDGF-B gene following subcutaneous administration 
in C57B16 mice The data is in support of a therapeutic application of the PDGF-B vector The proposed use of the vector 
is to facilitate cutaneous wound healing in poorly perfused tissue resulting from advanced stage diabetes and is expected to 
be injected subcutaneously at the wound site 
The non-replicative adenoviral vector H5020CMVPDGF-B was injected subcutaneously in 10 male and 10 female C57BL6 
mice at 1010 viral particlesdose Tissue samples were taken on Day 4 and Day 60 and were analysed for vector DNA 
AdPDGF copy number Tissue samples taken and analyzed included skin at the injection site dorsal thorax abdominal 
skin negative control brain right kidney intestine liver right testis ovaries spleen lung heart right axillary lymph node 
bone marrow and blood On Day 4 substantial distribution of vector DNA was detected in the right axillary lymph node of 
610 mice distribution ranged from 0-7 of total vector DNA detected In 910 treated mice on Day 4 the vector was 
localized primarily to the injection site The one Day 4 mouse that did not have most of the detected vector DNA localized to 
the injection site had detectable vector DNA in all tissues tested including blood These observations indicated that 
AdPDGF DNA entered the blood stream from the injection site This animal was also the only treated animal to lose weight 
by Day 4 and was observed to have a hunched posture after treatment The etiology of these symptoms is unknown but 
may be associated with the systemic distribution of the adenoviral vector in this animal In the other Day 4 mice some 
limited distribution of the adenoviral vector was seen in selected organs liver spleen lung but none was detected in the 
blood By Day 60 the average level of AdPDGF DNA localized to the injection site had decreased by 79-85 in males and 
females In 110 treated mice 2M220 substantial levels of AdPDGF DNA were found in the kidney liver and intestine This 
was considered evidence of previous systemic distribution probably through the introduction of vector into the blood stream 
after dosing No clinical findings or significant body weight losses were associated with this animal during the course of the 

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