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Biotech / Medical : Valentis (VLTS) -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (60)11/14/2001 1:27:58 PM
From: tuck  Read Replies (1) | Respond to of 81
 
>>BURLINGAME, Calif., Nov. 14 /PRNewswire/ -- Valentis, Inc. (Nasdaq: VLTS - news) today announced that the results of a 54 patient, randomized, double-blind, placebo-controlled Phase II clinical trial showed that the VEGF165 gene incorporated into one of Valentis' proprietary lipid delivery systems can induce angiogenesis (the formation of new blood vessels) in the legs of patients with peripheral arterial disease. The trial also demonstrated that the VEGF165 gene delivered with Valentis' lipid delivery system was as effective as the VEGF165 gene delivered by an adenoviral vector. Additionally, the safety issues associated with adenoviral vectors were not seen in patients receiving the gene delivered with Valentis' lipid delivery system. The results of this trial, conducted in Finland by Professor Seppo Yla-Herttuala and colleagues were presented this morning at the annual meeting of the American Heart Association.

All of the patients enrolled in this trial had peripheral arterial occlusive disease and were treated with percutaneous transluminal angioplasty. Following the angioplasty procedure, the patients were given a single administration of the VEGF165 gene delivered with either Valentis' lipid delivery system, an adenoviral vector, or a placebo.

Prof. Yla-Herttuala noted, ``The results of this study suggest that there is increased vascularity in the VEGF-treated limbs of the trial patients with both the lipid delivery system and with the adenovirus. Even though an adenovirus is usually the most efficient gene transfer vector, this trial showed that it was not superior to the lipid delivery system.''

``We believe that a major clinical milestone for the gene therapy field was achieved by Prof. Yla-Herttuala's study,'' commented Dr. Tyler Martin, Senior Vice President of Development at Valentis. ``In a controlled trial that compared in vivo delivery of a VEGF gene against a placebo, the gene therapy was shown to have a statistically significant effect in creating new blood vessels in humans. Prof. Yla-Herttuala's results also validate the utility of Valentis' proprietary lipid delivery systems to deliver therapeutic genes by showing efficacy comparable to viral vectors in creating proteins that have a therapeutic effect in patients. We expect additional data to confirm the results seen in this trial, and that the creation of new blood vessels will result in improved functional status for these patients.''<<

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Cheers, Tuck