Sangamo BioSciences announced top-line results from a Phase 2 study of SB-509 for the treatment of diabetic neuropathy (DN). In this double-blind, repeat dosing, placebo-controlled clinical study, patients received treatment at 0, 60, and 120 days. The neuroregenerative effect of SB-509 was assessed by measuring intraepidermal nerve fiber density (IENFD), determined from 3mm skin punch biopsies taken from the thigh at baseline (Day 0) and 30 days after the final treatment (Day 150). Patients treated with SB-509 demonstrated a statistically significant (p=0.02) increase in small unmyelinated nerve fibers in the skin, or IENFD, from baseline.

SB-509 is an injectable plasmid encoding a DNA-binding Zinc Finger DNA-binding Protein (ZFP) transcription factor (ZFP TF) designed to upregulate endogenous expression of the gene encoding vascular endothelial growth factor (VEGF-A). VEGF-A has been demonstrated to have direct angiogenic, neurotrophic and neuroprotective properties. SB-509 has shown efficacy in protecting motor and sensory nerve function from disease-induced nerve damage in preclinical animal efficacy studies.

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