Human leukocyte antigen (HLA)-B7/beta-2 microglobulin plasmid DNA/lipid complex, otherwise known as Allovectin-7 (Vical, Inc., San Diego, CA, USA), has been developed as a non-viral gene delivery product. After multiple laboratory and human trials, it appears that the concept of gene transfer has established itself as a clinical reality. While the manifestations of the gene transfer have not been as dramatic as one might have hoped, HLA-B7/beta-2 microglobulin plasmid DNA/lipid complex appears to be a promising agent with an extremely safe toxicity profile. Ongoing trials are further investigating potential clinical uses of Allovectin-7.