Monday, October 03, 2011 9:52:22 AM
Sangamo BioSci announces Phase 2b trial of SB-509 in diabetic neuropathy did not meet key study endpoints (SGMO) 4.35 : Co announced that its Phase 2b study did not meet its primary or secondary clinical endpoints in subjects with moderate severity diabetic neuropathy as compared to placebo. SB-509 treatment did not show statistically significant improvements from baseline compared with placebo at 180 days in the primary endpoint, sural nerve conduction velocity the secondary endpoint, neuropathy impairment score in the lower limb or intraepidermal nerve fiber density. SB-509 was generally well-tolerated. There were three serious adverse events in the SB-509 treated group compared with three serious adverse events in the placebo group. The remaining adverse events were mild and reversible and were generally equivalent in both groups. (stock halted)
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