San Diego, California April 6, 2006 Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today positive results from the Phase 1 human clinical trial of SB-509, the Company's ZFP Therapeutic for the treatment of diabetic neuropathy. Safety data and preliminary findings regarding improvement of symptoms were presented at the 58th Annual Meeting of the American Academy of Neurology in San Diego by David Cornblath, M.D., Professor of Neurology at The Johns Hopkins University School of Medicine and a consultant to Sangamo. The results are the first publicly reported data from a human clinical trial of a ZFP Therapeutic.
SB-509 represents a new approach in treating diabetic neuropathy, designed to directly protect and restore nerve function by upregulating the expression of the gene encoding vascular endothelial growth factor (VEGF-A) in diabetics suffering from peripheral neuropathy. The study, designed primarily to test clinical and laboratory safety, was a single blind, single treatment, dose-escalation trial in patients with mild to moderate diabetic peripheral neuropathy. Twelve subjects were treated, with SB-509 administered by intramuscular injection in a distribution along the major peripheral nerves in the legs and feet. Monitored for safety throughout the study, the subjects were also evaluated for changes in symptoms and underwent neurological examination and quantitative sensory testing at one, two, three and six months.
All of the safety end-points of the study were met. Adverse events were limited to mild injection site reaction, there were no serious drug-related events (SAEs), and no dose-limiting toxicities were observed. In addition, improvements in pain, numbness and neurological symptoms were observed in approximately 50 percent of patients who received a single treatment of SB-509. Anecdotal improvements were also reported in neurologic exam scores and electrophysiologic testing.
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