Sangamo BioSciences Announces Presentation of Top-Line Statistically Significant Phase 2 Data in Diabetic Neuropathy at Society for Neuroscien...(was also statistically significant (p-va...),Health

Date:10/20/2009

was also statistically significant (p-value = 0.03) with a 13.3 difference in average rank. A trend towards improved IENFDR was also observed in SB-509 treated subjects compared to placebo. Taken together these data are direct histological evidence of improved axonal regeneration with intramuscular administration of SB-509.

As previously described, no overall difference was seen at 180 days between placebo and SB-509-treated subjects in the SB-509-601 study in the following measures of nerve health and function: Abbreviated Neuropathy Impairment Score in the Lower Limbs (A-NIS-LL), Nerve Conduction Velocity (NCV), and Quantitative Sensory Testing (QST). However, analysis of the data demonstrated that subjects entering the SB-509-601 trial had significantly milder DN by all of these measures than subjects in either the prior Phase 1 SB-509-401 study in a mild to moderate population or a second Phase 2 SB-509-701 study in a more severe population (p value=0.0001). When the effect of baseline severity of DN as determined by IENFD was analyzed, a statistically significant and clinically relevant improvement in IENFD was observed in subjects with more severe DN (i.e. fewer nerve fibers per mm). Thus subjects with lower baseline IENFD demonstrated a greater response to SB-509 treatment by this measure.

When other clinical responses to SB-509 compared to placebo were analyzed in subjects with more severe disease (baseline IENFD below 9 fibers per mm) improvements in NIS-LL and sural NCV were observed to be clinically relevant and durable. Furthermore, in this group, when the muscle component of the NIS-LL was specifically analyzed, treatment dependent muscle strength improvements were evident in SB-509-treated compared with placebo-treated subjects. When multiple baseline measures of disease severity were considered (IENFD, ICAM-1, NCV and NIS-LL), a drug responder population was identified that demonstrated a clinically relevant change in N
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SOURCE Sangamo BioSciences, Inc. Copyright©2009 PR Newswire. All rights reserved

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