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Deltavasc, VLTS 934 Demonstrate Statistically Significant Improvements in Exercise Tolerance and Ankle Brachial Index

NEW ORLEANS, Nov. 8 /PRNewswire-FirstCall/ -- Valentis, Inc. (Nasdaq: VLTS) announced that further results of its Phase II clinical trial of Deltavasc(TM) (Del-1 angiogenesis gene plus VLTS 934) versus VLTS 934 alone in patients with the intermittent claudication form of peripheral arterial disease were presented at the American Heart Association Scientific Sessions 2004 in New Orleans, LA today. Initial results had been announced September 29, 2004.

Findings from the trial indicate that both the Deltavasc(TM) and VLTS 934 groups demonstrated statistically significant improvements in both exercise tolerance and ankle brachial index over baseline and no statistically significant difference between treatment groups.

At the 90-day assessment, the VLTS 934 group of 51 patients had a significant increase in exercise tolerance from baseline of 34% (p Patient demographics and results of secondary endpoints were virtually identical. The only subgroup analysis that was predictive of patient outcomes was age. Patients over 80 years of age in the trial responded more poorly than younger patients.

"The improvement in exercise tolerance in both groups was virtually identical and well above the approximate 18% placebo effect observed in previous trials of similar design," said Stuart Young, M.D., Medical Director at Valentis. We are encouraged by these results which may ultimately provide a novel means to treat peripheral arterial disease with greater safety and efficacy."

Phase II Trial
This was a randomized, double-blind, placebo-controlled trial of 100 patients at 17 centers in the US. Patients eligible for entry into the trial had evidence of active intermittent claudication at baseline. Patients were randomized equally to receive either 84 mg of Deltavasc(TM), which is a formulation of a 5% solution of VLTS 934 mixed with the Del-1 gene, or a 5% solution of VLTS 934 alone. VLTS 934 was formulated with the Del-1 gene because it more broadly distributes the gene to cells resulting in increased cellular uptake of the gene and increased production of the angiogenic protein from the cells. VLTS 934 is a non-ionic polyoxyethylene-polyoxypropylene block copolymer known as a poloxamer. At the cellular level, the mechanism of action for VLTS 934 is an increase in micro vascular blood flow. Additional preclinical studies are being conducted to better understand the sub cellular pharmacologic basis of this activity. It is believed that VLTS 934 is having its effect at the arteriolar and capillary level following its administration into muscle and subsequently exerting its pharmacologic effect over a prolonged period. This is consistent with the improvements in ankle brachial index seen in this Phase II trial.

About Peripheral Arterial Disease
Lower extremity peripheral arterial disease (PAD) is a common disorder that occurs when the arteries that carry oxygen rich blood from the heart to the legs become severely narrowed and sometimes blocked through the accumulation of plaque (atherosclerosis). The number of patients with PAD is large and growing. PAD is estimated to affect about 63 million people in the U.S., Europe and Japan. PAD becomes more common as one gets older. It is estimated that five percent of adults over the age of 55 have PAD and that nearly 20 percent of Americans over the age of 70 have PAD. Diagnosis is critical, as people with PAD face a six to seven times higher risk of heart attack or stroke. The risk factors for PAD are similar to those of other cardiovascular and cerebrovascular diseases such as smoking, obesity, genetic predisposition, lack of regular exercise and a high-fat diet.

Source: Valentis

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