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About SB-509
SB-509 is an injectable formulation of a plasmid encoding a zinc finger DNA-binding protein transcription factor (ZFP TF(TM)) designed to upregulate the expression of the gene encoding vascular endothelial growth factor (VEGF- A). VEGF-A has been demonstrated to have direct neurotrophic and neuroprotective properties. In preclinical animal efficacy studies in a diabetic rat model (Diabetes, June 1, 2006; 55(6): 1847-1854), SB-509 has proven effective in protecting motor and sensory nerve function from disease- induced nerve damage.
Phase 2 Study of SB-509 for Mild to Moderate DN (SB-509-601)
The study is a double-blind, placebo-controlled, repeat-dosing multi- center study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs.
110 subjects were enrolled into the trial. Subjects were randomized to one of two groups. The larger group was treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every two months. The remaining group received an equal volume of placebo on the same schedule. Each subject received a total of three treatments (Day 0, 60 and 120). Subjects received injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.
The symptoms of diabetic peripheral neuropathy and any changes that
occur during the trial were evaluated based on neurological ex
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| SOURCE Sangamo BioSciences, Inc. Copyright©2008 PR Newswire. All rights reserved |