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news.Sangamo BioSciences has submitted an investigational new drug application to the FDA for a novel therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetic neuropathy.
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SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene. VEGF A has been demonstrated to have direct neuroproliferative, neuroregenerative and neuroprotective properties.
In pre-clinical animal efficacy studies, SB-509 has proven effective in protecting motor and sensory nerve function in a diabetic model and in stimulating nerve regeneration.
“Our first IND filing is a major milestone for Sangamo and brings us closer to addressing a serious unmet medical need for the diabetic population,” said Edward Lanphier, Sangamo’s president and CEO.
“Currently, the only approved drugs being used treat the symptoms of diabetic neuropathy, there is nothing approved for therapy of peripheral nerve function. We believe that our ZPF Therapeutic, SB-509, may provide a new approach to treating this debilitating condition.”
Pending FDA review of the an investigational new drug application (IND), a multicenter phase I/II human clinical trial is scheduled to begin in the first half of 2005. The single-blind, dose-escalation study is designed to evaluate clinical safety of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs.