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

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.