Sangamo phase 1 trial of SB-509 for diabetic neuropathy meets safety endpoints

By Lisa Kerner

Erie, Pa., April 6 - Sangamo BioSciences, Inc. said all of the safety endpoints were met in its phase 1 clinical trial of SB-509, a ZFP Therapeutic for the treatment of diabetic neuropathy.

The company presented the safety data and preliminary findings at the Annual Meeting of the American Academy of Neurology in San Diego.

SB-509 is designed to protect and restore nerve function by up-regulating the expression of the gene encoding vascular endothelial growth factor (VEGF-A) in diabetics suffering from peripheral neuropathy, according to a company news release.

The study was a single-blind, single-treatment, dose-escalation trial in 12 patients with mild to moderate diabetic peripheral neuropathy. SB-509 was administered by intramuscular injection.

Subjects underwent neurological examination and sensory testing at one, two, three and six months. Pain was assessed using the Visual Analog Scale.

Adverse events were limited to mild injection site reaction, Sangamo said. Improvements in pain, numbness and neurological symptoms were observed in roughly 50% of subjects who received a single treatment of SB-509.

The company said it plans to conduct a placebo-controlled phase 2 clinical trial of SB-509 in the second half of this year.

Diabetic peripheral neuropathy results in numbness, tingling sensations and pain, particularly in the toes or feet. The American Diabetes Association estimated that up to 70% of the roughly 18.3 million people with diabetes in the United States have mild to severe forms of neuropathy.

San Diego-based Sangamo researches and develops novel zinc finger DNA-binding protein transcription factors for therapeutic gene regulation and modification.

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