Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication

Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.

Inclusion criteria

• Age>40 years
• History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
• Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
• Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography

Exclusion criteria

• Evidence of other causes for leg pain other than intermittent claudication.
• Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)
• Pain at rest
• Buerger's disease
• Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
• Subjects with serum creatinine > 2 mg/dl (176 µmol/l) and subjects on dialysis.
• Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
• Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
• Previous treatment with any angiogenic growth factor
• Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
• Serious concomitant medical conditions not adequately controlled.
• Current alcohol or drug abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.