Valentis' Del-1: PI results in peripheral arterial disease
BURLINGAME, Calif., June 9 /PRNewswire-FirstCall/ -- Valentis, Inc. (Nasdaq: VLTS - News) announced today that it presented data from a Phase I clinical trial of the Company's Del-1 angiogenesis product for the treatment of peripheral arterial disease. The presentation was made at the 6th Annual Meeting of the American Society of Gene Therapy in Washington, D.C.
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).
About Valentis
Valentis is converting biologic discoveries into innovative products. The Company's lead product in human testing is the Del-1 angiogenesis gene formulated with one of the Company's 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. Additional information is available at valentis.com . |
