Sangamo BioSciences Provides Update on Diabetic Neuropathy Clinica...(ly 30 subjects) was treated by intramusc...),Health

Date:6/6/2008

ly 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.

The expansion protocol will enroll 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 a similar pattern to that used in the initial part of the trial.

"In our Phase 1 studies we noted interesting clinical improvements in a number of subjects," said Edward Lanphier, Sangamo's president and CEO. "In addition to improvement in quantitative sensory testing (QST), three subjects with so-called "blocked nerves" or unmeasurable nerve conduction velocity measurements in the leg showed recovered and improved NCV after a single treatment with SB-509 and two of the three subjects showed recovery and improvement past a six-month follow-up period. As these observations were made in the Phase 1 trial, which studied only a small number of subjects, we initiated a Phase 2 trial, SB-509-701, to further investigate this finding. Our primary review of data from the SB-509-701 study continued to show a marked neurophysiologic improvement in severe diabetic neuropathy patients with unmeasurable nerve conduction velocities treated with SB-509. Based upon these observations we plan to
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SOURCE Sangamo BioSciences, Inc. Copyright©2008 PR Newswire. All rights reserved

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