Report Summary

Toxicology and Biodistribution Study of Adenylyl Cyclase VI Gene Transfer for Congestive Heart Failure Summary of Findings

Study Summary

Overall Study Design 
The objective of this study was to determine the potential toxicity of single doses of human adenovirus-5 encoding human 
adenylyl cyclase Type VI hAd5hACVI in pigs following intracoronary administration The overall study was divided into two 
separate parts the primary toxicology study and the biodistribution study The study consisted of 5 experimental arms The 
subjects underwent intracoronary injection of PBS alone Group 1 nitroprusside alone Group 2 or hAd5hACVI with 
nitroprusside 50 gmin 3 min for each of the three coronary arteries at one of the following doses 32 x 10e10 vp Group 
3 32 x 10e11 vp Group 4 32 x 10e12 vp Group 5 The vector was delivered by intracoronary injection with a 
simultaneous infusion of nitroprusside to increase the extent of gene transfer 
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