Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Associati... (tion of SB-509 in diabetics with moderat...)

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

Date:6/8/2008

tion of SB-509 in diabetics with moderate to severe diabetic peripheral sensory motor neuropathy in the legs. The trial is being conducted at multiple sites, accrual has been completed and plans recently announced to expand the study and enroll additional subjects.

In the initial trial, 45 subjects have completed enrollment. Subjects were randomized to one of two groups in a 2:1 ratio. The larger group (approximately 30 subjects) was treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb and will be treated every 3 months. The remaining group (approximately 15 subjects) received an equal volume of placebo on the same schedule. Each subject will receive a total of two treatments (Day 0 and 90). Subjects receive injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.

As announced on June 6, 2008, Sangamo will expand the Phase 2 study by enrolling approximately 45 additional subjects in the trial. Subjects will again 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 2 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 three treatments (Day 0, 60 and 120). Subjects will receive injections in the same pattern used in the initial part of the trial.

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 assess pain using VASPI, and use scoring systems such as a modified NIS-LL and TNS to quantify neurologic exam and assess signs and symptoms of the condition.

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