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Sangamo BioSciences Announces Completion of Enrollment of Phase 2 Clinical Trial of ZFP Therapeutic for Diabetic Neuropathy
Date:12/4/2007

pletion of enrollment of the trial triggers a milestone payment from JDRF under this agreement.

About SB-509

SB-509 is a formulation of a zinc finger DNA-binding protein transcription factor (ZFP TF) designed to upregulate the expression of the gene encoding vascular endothelial growth factor (VEGF-A). Sangamo is currently evaluating this ZFP Therapeutic in a second ongoing Phase 2 clinical trial for the treatment of moderate to severe DN; plans to initiate a third Phase 2 trial to evaluate the effect of SB-509 on the mobilization of stem cells in subjects with DN; and has a preclinical program targeting spinal cord injury. Sangamo has also announced a new clinical program, the initiation of a Phase 2 clinical trial in Amyotrophic Lateral Sclerosis (Lou Gehrig's disease) in the first half of 2008.

Phase 2 study of SB-509 for mild to moderate DN

The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs.

A total of 102 subjects have been enrolled into the trial. Subjects were randomized to one of two groups in a 2:1 ratio. The larger group is being treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every 2 months. The remaining group is receiving an equal volume of placebo on the same schedule. Each subject will receive a total of three treatments (Day 0, 60 and 120). Subjects will receive injections in a distribution pattern that targets the skeletal muscle adjacent to the major peripheral nerves in the legs and feet.

The symptoms of diabetic peripheral neuropathy and any changes that occur during the trial will be evaluated based on neurological examination data, electrophysiological testing data, subject neurological questionnaire, and subject pain assessment. Investigat
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SOURCE Sangamo BioSciences, Inc.
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