Valentis Inc announced completion of the initial follow-up of the last patient in the final cohort of the Phase I clinical trial for its lead product, del-1. Twenty patients with peripheral arterial disease (PAD) have been enrolled and treated in this trial with no severe adverse events reported relating to the drug or method of administration. The results of this trial have allowed the Company to choose a dose and dosing pattern for the Phase II safety and efficacy trial scheduled to start in the second quarter of 2003.
Del-1 is a protein involved in the early growth and development of blood vessels. It is a unique angiogenic factor that promotes vascular growth and inhibits endothelial cell death. Del-1 has a distinct mechanism of action from other known angiogenic factors such as members of the VEGF and FGF families. By stimulating angiogenesis, del-1 has demonstrated the potential to be effective in the treatment of a variety of cardiovascular diseases, including peripheral arterial disease (PAD) and ischemic heart disease (IHD).
Valentis is converting biologic discoveries into innovative products. The Company's lead product is based on the del-1 angiogenesis gene, formulated with one of the Company's PINC proprietary polymer delivery systems. The Company is developing its other technologies, the GeneSwitch and DNA vaccine delivery technologies, through partnerships with pharmaceutical and biotechnology companies.