Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
The primary objective is to evaluate safety and tolerability of single and repeated
 administrations of escalating doses of NV1FGF administered intramuscularly in patients with
 severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or
 Grade III, category 5 and 6).

 Secondary objectives are:

 -  To determine the biological activity of NV1FGF on collateral artery development.

 -  To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.
Screening period of 30 days before dosing. Patients receive a single administration or
 repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed
 for a period of 6 months
Inclusion criteria:

 -  Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and
 6

 -  Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the
 previous 14 days with no signs of healing (no reduction in ulcer size or depth)

 -  Objective evidence of peripheral vascular disease (resting Ankle Brachial Index < 0.4
 and/or resting Toe Brachial Index < 0.3 and/or metatarsal Peripheral Vascular
 Resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations
 performed at least 2 weeks apart)

 -  Angiographic demonstration of total occlusion of the affected limb of one or more of
 the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries

 -  Poor candidate for surgical intervention or revascularization procedures (no tibial
 artery incontinuity as defined from mid-leg distance from the foot and no autologous
 tissue available)

 Exclusion criteria :

 -  Previous or current history of malignant disease. Patients who had successful tumor
 resection more than 10 years prior to inclusion into the study and had no recurrence
 and patients who had curatively resected basal/squamous cancer of the skin were
 allowed for inclusion

 -  Abnormal chest X-ray with suspected malignant tumor presence

 -  Positive stool hemoccult (expect if due to hemorrhoids)

 -  Positive Prostate Specific Antigen for men with suspected malignant tumor presence

 -  Abnormal mammography for women with suspected malignant tumor presence

 -  Papanicolaou smear (for women) of Class IV or Class V characterization

 -  Proliferative retinopathy

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