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Sangamo BioSciences Announces Presentation of Top-Line Statistically Significant Phase 2 Data in Diabetic Neuropathy at Society for Neuroscience Meeting
Date:10/20/2009

a greater improvement in sural NCV in SB-509 treated subjects. Together these data provide support for our hypothesis that the dual neuroregenerative and angiogenic functions of SB-509 are important for improvement of nerve health by counteracting the pathologic effects of diabetes on nerves and blood vessels in these subjects. In future clinical studies, IENFD and ICAM-1 levels will serve as an important baseline measurement to aid in identification of a target population of SB-509 responsive DN patients and as a stratification variable to ensure that we have well-balanced treatment and placebo groups."

IENFD is a validated, direct biologic measurement of small unmyelinated sensory nerve fibers in the skin, the primary nerves involved in DN. It has also been demonstrated to correlate with neuropathy severity in diabetes, nerve fiber densities derived from sural nerve biopsies and levels of vascular endothelial growth factor-A (VEGF-A).

Data were also presented that demonstrate that in subjects with more severe neuropathy, as judged by their baseline IENFD, a greater nerve regrowth response to SB-509 treatment was observed compared to regrowth responses in placebo-treated subjects. In addition, subgroup analyses using baseline severity of disease as a selection criterion, demonstrated that SB-509 treatment resulted in correlative clinically relevant improvements in NIS-LL and sural NCV in subjects with moderate to severe disease.

"Loss of small unmyelinated nerve fibers is an early symptom of DN and the positive IENFD data have given us insight into the population of subjects that we expect will show the greatest response to SB-509 treatment over the 180 day clinical study period," said Edward Lanphier, Sangamo's president and CEO. "This is the first large placebo controlled study to show the value of IENFD in clinical studies of DN and we have gathered a significant amount of clinically relevant correlative data that will a
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SOURCE Sangamo BioSciences, Inc.
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