Sangamo BioSciences has completed subject enrollment and treatment in its Phase I study of SB-509 in subjects with mild-to-moderate diabetic neuropathy. SB-509 is a novel ZFP therapeutic designed to upregulate the expression of the patient's own vascular endothelial growth factor gene to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy.
This single-blind, placebo-controlled, single-treatment, dose-escalation trial is designed to evaluate clinical safety of SB-509 in diabetics with mild-to-moderate diabetic peripheral sensory motor neuropathy in both legs. Twelve subjects have been treated in the trial all of whom received treatment in one leg and placebo in the other. Either SB-509 or the placebo was administered by injection in a distribution that targets the major peripheral nerves in the legs and feet. Four dose-levels of drug were tested. Safety will be monitored throughout the study, and visits at one, two, three and six months include neurological examination and electrophysiological testing.