Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sangamo Biosciences; Sangamo Therapeutics
• Collaborator: Juvenile Diabetes Research Foundation

Criteria

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)