Stable lipid/DNA complexes for intravenous delivery of genes

We have focused on the development of lipid based gene transfer vehicles for intravenous administration. This program was initiated two and half years ago. The projected pharmaceutical product at that time was a two vial system containing liposomes composed of cationic lipids in one vial and DNA in another vial. The contents were mixed together just prior to administration. This was viewed as a source of variability in comparing a single formulation in multiple experiments or comparing multiple formulations in a single experiment. This variable was eliminated by developing lipid/DNA complexes that could be stored as a suspension for a minimum of 4 months at 4°C.