Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

History of exercise-limiting intermittent claudication and peripheral arterial disease with symptoms in one or both legs, of at least 2 months duration with no change in symptom severity in the 2 months prior to screening.
A Doppler-measured ankle-brachial index (ABI) of ≤0.80 or toe-brachial index (TBI) of <0.70 in at least one leg after 10 minutes of rest.
Limitation in walking secondary to claudication with a mean peak walking time (PWT) of between 1 and 10 minutes on a standardized Gardner protocol for exercise treadmill test (ETT).
Angiographic or equivalent anatomic evidence (MRA) of arterial occlusive disease (>70%) in the distal common femoral artery or superficial femoral artery and its branches of at least one leg within 12 months prior to screening.
Postmenopausal (females),surgically sterile, or use adequate birth control.

Exclusion Criteria:

Presence of significant inflow disease [defined as >50% stenosis] in the distal aorta, common or external iliac as assessed by conventional angiogram, digital subtraction angiography (DSA), or magnetic resonance angiography (MRA) performed < 1 year prior to screening.
Critical limb ischemia, either chronic or acute ischemia manifested by rest pain, ulceration, or gangrene (Category 4 through 6 of Society for Vascular Surgery [SVS] classification [Rutherford]).
History of malignant neoplasm (except curable non-melanoma skin malignancies).
Renal failure (serum creatinine >2.0 mg/dL) or end-stage renal disease(requiring hemodialysis or renal replacement therapy).
Significant hepatic disease (>3-fold elevation in ALT/AST).
HBV or HCV carriers.
Severe pulmonary disease (e.g. severe chronic obstructive pulmonary disease).
Subjects with Acute Stroke within 6 months prior to screening.
Subjects with uncontrolled diabetes mellitus.
Specific ophthalmologic conditions that preclude retinal photography,vascular lesions of the anterior segment of the eye, proliferative retinopathy, age-related macular degeneration or intra-ocular surgery within 6 months prior to enrollment.
Gross obesity (BMI≥40).
Buerger's disease or other forms of inflammatory arteritis.
Class IV congestive heart failure, as defined by the New York Heart Association or a myocardial infarction within 6 months prior to screening.
Subject with deep vein thrombosis within 3 months prior to screening.
Inability to complete the standardized treadmill protocol for reasons other than claudication including symptoms such as angina, dyspnea, joint pains, or excessive fatigue.
Percutaneous intervention or surgical revascularization in the index lower limb within 6 months prior to enrollment.
Heart angioplasty with or without stent or coronary bypass surgery within the past 6 months.
Participation in a structured exercise treatment protocol within 30 days prior to screen testing.
Subject is planning to participate in a structured exercise treatment protocol during the 180 days following administration of the investigational product.
Participation in a previous gene transfer trial in which the subject received active investigational product (placebo subjects are eligible).
Concurrent or prior participation in another clinical trial within 30 days prior to screen testing.
Chronic use of Cox-2 inhibitors, defined as subjects needing daily use of the agent for more than 30 days prior to screening.
Subject is taking any of the following drugs for life-threatening conditions or as part of a life-sustaining treatment: Cyclosporine (Sandimmune®),Systemic androgens/anabolic steroids, systemic corticosteroids.
History of bleeding diathesis (e.g. hemophilia due to Factor VIII or IX deficiency).
Pregnancy or breast-feeding.
Uncontrolled hypertension or significant hypotension.
Immunodeficiency states (e.g, current HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medications.
Alcohol or other substance abuse.