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Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Association Meeting
Date:6/8/2008

the trial is expected to take approximately fourteen months: two months for screening, three months for subject treatment and a further nine months for subject follow-up. Individuals interested in participating in this trial should visit http://www.clinicaltrials.gov/ .

Phase 2 Study of SB-509 to Evaluate Stem Cell Mobilization (SB-509-703)

Twenty subjects will be enrolled in the stem cell mobilization Phase 2 trial. Subjects will be randomized to one of four cohorts with 5 subjects in each cohort. Cohorts 1 and 2 will receive a single treatment of 30 mg into one leg or 60 mg (30 mg in each leg) of SB-509, respectively, by intramuscular (IM) injection on Day 0. Cohort 3 will receive a single treatment of an equal volume of placebo by IM injection into a lower limb on Day 0. Cohort 4 will receive two treatments of 60 mg of SB-509 (30 mg in each leg) by IM injection (Day 0 and 90). Subjects will receive injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.

Peripheral blood samples taken before and at various times post-treatment with SB-509 will be assayed and the numbers of circulating stem cells will be assessed using stem cell-specific enzymatic activity (aldehyde dehydrogenase staining), culture-based assays, as well as assays of cell surface expression of stem cell-specific markers.

The signs and symptoms of diabetic peripheral neuropathy and any changes that occur during the trial will also be evaluated based on neurological examination data (NIS-LL), electrophysiological testing data, subject neurological questionnaire, and subject pain assessment (VASPI). Specifically, investigators will use the following tests: QST with the Vibratron II instrument, to assess the threshold of detection of vibration and electrophysiological testing. A total neuropathy composite score (TNS) will also be computed to evaluate changes in nerve health.
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SOURCE Sangamo BioSciences, Inc.
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