Leuvectin is a plasmid
DNA/
lipid complex comprised of a plasmid
DNA expression vector (VCL-1102, 30) encoding human
interleukin (IL)-2 complexed in a 5:1 mass ratio with
DMRIE/DOPE
lipid that has been developed for the treatment of
cancer.
DMRIE/DOPE is a cationic
lipid, which facilitates in vitro and in vivo transfection of plasmid
DNA. In vitro transfection with the
IL-2 plasmid
DNA/
DMRIE/DOPE complex results in the expression of sustained levels of biologically active
IL-2. Human tumor cell lines and primary human
tumor cells established from biopsies were readily transfected in vitro resulting in the expression of
IL-2. Following in vitro transfection,
IL-2 expression continued up to several weeks post-transfection in primary
tumor cells. In preclinical efficacy studies in a murine model of
renal cell carcinoma (RCC), the direct intratumoral administration of an
IL-2 plasmid
DNA/
DMRIE/DOPE complex resulted in the generation of
tumor specific lymphocytes and complete
tumor regression in the majority of the mice. In preclinical animal safety studies, repeated administration of
Leuvectin was safe and well-tolerated. Following these promising preclinical results,
Leuvectin has entered clinical trials and two pilot phase I/II trials are described.