Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Associati... (the trial is expected to take approximat...)

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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