Valentis Inc presented data from a Phase I clinical trial of the Company's Del-1 angiogenesis product for the treatment of peripheral arterial disease.
In the trial, there were no observed severe adverse events from the drug and Del-1 was well tolerated at all doses tested. Although the number of patients in each dose group was small, there appeared to be evidence of dose-related product activity.
"Based on our analysis of pre-clinical and clinical data, it has become very clear that Del-1 will be the primary driver of shareholder value for Valentis," stated Benjamin F. McGraw III, President and CEO of Valentis. The Del-1 product is comprised of a plasmid containing the Del-1 angiogenic gene and a proprietary polymer delivery system. Pre-clinical data have demonstrated that the product results in new capillary and arteriole formation and improved exercise tolerance with no associated drug related toxicity.
In the Phase I clinical trial, 20 patients with peripheral arterial disease were enrolled in an open-label, dose escalation study to determine product safety in humans. The patients, divided into 6 groups, received intra-muscular doses of product ranging from 3 to 84 mg administered to a diseased leg. The results of this trial allowed the Company to choose a dose and dosing pattern for the 100 patient randomized, placebo controlled, double-blinded Phase II safety and efficacy trial scheduled to begin mid 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 vascular diseases, including peripheral arterial disease (PAD) and ischemic heart disease (IHD).