Phase II clinical trial for new gene transfer drug study

As many as 8-10 million Americans have Peripheral Artery Disease (PAD), by age 70, roughly 20 percent of the population has it, and people with PAD face a six-to-seven times higher risk of heart attack or stroke.

PAD, commonly seen in patients with a history of smoking, diabetes, and/or coronary artery disease, is the build up of fatty deposits in the inner linings of the artery walls of the heart and brain. These blockages restrict blood circulation, mainly in arteries leading to the kidneys, stomach, arms, legs and feet. In its early stages a common symptom is uncomfortable cramping or fatigue in the legs brought on by walking and relieved with rest--a condition called intermittent claudication.

The WALK study, led by the Mount Sinai School of Medicine and sponsored by Genzyme Corporation, will determine if a new gene transfer treatment, Ad2/HIF-1a/VP16, helps ease the pain caused by intermittent claudication.

"The leg pain experienced by people with PAD is very different than leg pain caused by joint problems or arthritis," said Dr. Jeffrey W. Olin, the Principal Investigator for the WALK study and Professor of Medicine at the Mount Sinai School of Medicine and Director of Vascular Medicine and the Vascular Diagnostic Laboratory in the Zena and Michael A. Wiener Cardiovascular Institute of The Mount Sinai Medical Center. "This gene transfer treatment could offer new hope for the millions of people that suffer from the leg pain associated with peripheral arterial disease."

HIF-1a (Hypoxia-inducible factor-one alpha gene) is produced naturally in the body when there is not enough oxygen reaching the leg tissue. The study drug, Ad2/HIF-1a/VP16, is very similar to the HIF-1a the body naturally produces but has been genetically changed to include important biological characteristics that may grow new blood vessels and improve blood flow in legs.

Mount Sinai and 40 other sites involved in the trial are seeking to enroll approximately 300 men and women in the United States and Europe. The study is open to male or female patients between the ages of 40-80 who suffer from PAD that has progressed to activity-limiting discomfort in at least one leg. The study will assess the safety and effectiveness of three different doses of Ad2/HIF-1a/VP16 compared to placebo in treatment of intermittent claudication.

A Phase I study was conducted using Ad2/HIF-1a/VP16 in patients with Critical Limb Ischemia and preliminary safety and potential bioactivity were demonstrated. Regulatory authorities in both the United States and Europe have reviewed this protocol and authorized Genzyme to proceed with enrollment.

If you are interested in participating, please call (212) 241-8902 or visit www.walkstudy.com.

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