Phase II gene transfer therapy study using an investigational drug to stimulate blood vessel growth in the legs of patients with intermittent claudication

The purpose of this study is to evaluate the safety and potential effect of an investigational drug compared to placebo for patients with leg pain due to intermittent claudication. Patients who have narrowing of the vessels that supply their legs with oxygen-rich blood will be treated to potentially promote the growth of new blood vessels in their legs. The study will evaluate whether the potential growth of new blood vessels and increased blood flow will allow patients to walk further distances without pain.

To participate in this study you must:

• Be between 40 and 80 years of age
• Have a clinical diagnosis of peripheral artery disease (PAD), secondary to atherosclerosis in both limbs
• Have an ankle-brachial index (ABI) of 0.9 or less at rest in at least one leg or a toe-brachial index (TBI) of 0.7 or less

This is a partial list of eligibility criteria. To inquire about your specific eligibility, please call the number provided. If you wish to inquire via e-mail, please refer to the study title in your correspondence.