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news.Gene technology company, Sangamo BioSciences has initiated a phase I clinical trial of SB-509, a novel therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy.
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The multi-center 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 trial, cleared by the FDA in February 2005, began with the screening and treatment of the first patient at the Diabetes and Glandular Disease Clinic in San Antonio, Texas. Other trial sites are expected to begin recruitment shortly and Sangamo expects to have up to a total of four sites participating in the study.
SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TFTM), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene, believed to have neurotrophic and neuroprotective properties.
“In previous studies, VEGF-A has been shown to be efficacious for maintenance of nerve function in this condition and we believe that our approach of activating the patient’s own VEGF-A gene directly may have important advantages over introducing a cloned gene or recombinant protein,” said Dale Ando, Sangamo’s vice-president of therapeutic development.
It is expected that approximately 12 patients will be treated in the trial. Subjects will receive injections in a distribution that targets the major peripheral nerves in the legs and feet. The trial is expected to take approximately 12 months to screen and enroll patients and six months for patient follow-up.