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

so observed a trend for improvement in SB-509 treated patients in a composite measure of nerve health, the Total Neuropathy Score or TNS. The TNS is a comprehensive approach to evaluating changes in nerve health and includes assessment of several factors, including neurologic exam, QST, electrophysiologic studies and neurologic symptoms.

In addition, data were presented from a subject with a "blocked nerve" in the leg. "Blocked nerves" are nerves, that in response to electrical stimulus, have no measurable induced nerve conduction velocity or NCV but are still functional. Typically, diabetics with blocked nerves have more severe symptoms of neuropathy. Following a single treatment with SB-509, recovered and improved NCV were observed in this subject over a six-month follow-up period.

Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer, stated, "In addition to improvement in TNS and QST, three subjects in our Phase 1b study with 'blocked nerves' showed recovered and improved NCV during a six-month follow-up period after a single treatment with SB-509. This suggests that SB-509 may have a role in nerve regeneration, which is consistent with preclinical observations in a spinal cord paralysis model of statistically significant improvement in hind limb function. To further investigate and confirm this finding of a potential nerve regeneration activity of SB-509 in DN we have initiated a repeat-dosing, single-blind Phase 2 trial in subjects with moderate to severe DN."

From a safety perspective, the Phase 1b data were consistent with previous observations that a single treatment of SB-509 was well tolerated and that no severe adverse events were observed. Importantly, subjects in the study were treated within the pharmacologically effective dose range that was demonstrated to be efficacious in preclinical animal studies. Injection site reactions were the most common adverse events reported and were mild and
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