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VLTS-589 is an investigational nonviral gene therapy designed for the treatment of peripheral vascular disease, specifically targeting intermittent claudication in patients with peripheral arterial disease. The drug consists of a plasmid encoding the angiomatrix protein Del-1 (developmentally regulated endothelial locus 1), formulated with poloxamer 188 to enhance gene transfer and transfection efficiency. Delivered via multiple intramuscular injections to both lower extremities, VLTS-589 aims to induce angiogenesis and arteriogenesis by promoting new blood vessel growth in ischemic tissues. Clinical studies have evaluated its safety and efficacy in improving exercise capacity (peak walking time), claudication onset time, ankle brachial index, and quality of life measures compared to baseline[1][3][4][5][8]. Developed by Valentis, this approach represents one of the largest plasmid-based gene transfer trials for therapeutic angiogenesis in peripheral artery disease.
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