A novel therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy
Sangamo BioSciences Files New Drug Application for ZFP Therapeutic to Treat Diabetic Neuropathy. Sangamo announced that it has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for ZFP, a novel therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy.
"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," stated their CEO,
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 preclinical animal efficacy studies, SB-509 has proven effective in protecting motor and sensory nerve function in a diabetic model and in stimulating nerve regeneration.
Pending FDA review of the 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.
"The Phase I/II trial is powered primarily to assess the safety and maximum tolerated dose of SB-509. However, the subjects enrolled in the study will be diabetics suffering from diabetic neuropathy," said Dale Ando, M.D., Sangamo’s vice president, therapeutic development and chief medical officer. "In a single visit, SB-509 will be administered to subjects via injection into one leg and placebo administered into the contra-lateral limb. This will allow us to evaluate effects of SB-509 on neurologic symptoms and electrophysiologic nerve function in the treated versus the untreated limb compared to baseline. The study is a multi-center trial involving sites experienced in treating diabetic neuropathy and there is great interest by these centers in participating in the initial trial of this novel approach and compound."