Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Key Inclusion Criteria:

• Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months
• Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
• Measurable sural and peroneal response bilaterally
• HgbA1C level ≤ 10%
• LDL cholesterol ≤ 160 mg/dL
• Blood pressure ≤ 140/90 mm Hg
• Body mass index (BMI) ≤ 38

Key Exclusion Criteria:

• Moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
• Evidence of cardiac enlargement and/or congestive heart failure
• Current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
• History of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
• Immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
• History of or current proliferative retinopathy, macular edema or retinal neovascularization
• Pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to VEGF stimulation
• Family history of inherited neuropathy (e.g. Charcot Marie Tooth, Hereditary Predisposition to Pressure Palsy)