Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Associati... (trial. Subjectshave been randomized to o...)

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

Date:6/8/2008

trial. Subjects have been randomized to one of two groups in a 2:1 ratio. The larger group (approximately 66 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 33 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 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), a modified Neuropathy Impairment Score - Lower Limbs (NIS-LL) scoring system as well as total neuropathy score (TNS) to assess signs and symptoms of the condition. A quantitative neurologic exam such as NIS-LL is widely regarded by neurologists as the most comprehensive approach to evaluating changes in nerve health. In addition, data from electrophysiological testing using nerve conduction velocity (NCV) to assess the rate at which a nerve can conduct an electrical signal, and quantitative sensory testing (QST) with the Vibratron II instrument, to assess the threshold of detection of vibration are also being collected. Skin biopsies will also be taken to evaluate the direct therapeutic effect of SB-509 on nerve regrowth. This test is a very sensitive marker of DN severity and may provide an important mechanistic marker for efficacy.

Phase 2 study of SB-509 for moderate to severe DN (SB-509-701)

The clinical trial is a single-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administra
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