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Sangamo BioSciences Announces Presentation of Phase 1 ZFP,Therapeutic Data at American Diabetes Association Meeting

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The trial is expected to take approximately 12 months to screen and enroll subjects, four months for subject treatment and a further 8 months for subject follow-up. Individuals interested in participating in this trial should visit http://www.clinicaltrials.gov/ or the Sangamo website at http://www.sangamo.com/.

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

The clinical trial is a single-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with moderate to severe diabetic peripheral sensory motor neuropathy in the legs. The trial will be conducted at multiple sites.

Approximately 45 subjects will be enrolled in the trial. Subjects will be randomized to one of two groups in a 2:1 ratio. The larger group (approximately 30 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every 3 months. The remaining group (approximately 15 subjects) will receive an equal volume of placebo on the same schedule. Each subject will receive a total of two treatments (Day 0 and 90). Subjects will receive injections in a distribution pattern that targets 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. Specifically, investigators will use the following tests: the visual analog scale for pain intensity (VASPI), total neuropathy score (TNS) to assess signs and symptoms of the condition.

For each subject the trial is expected to take approximately fourteen months: two months for screening, three months for s
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