Sangamo BioSciences Announces Presentation of Top-Line Statistically Significant Phase 2 Data in Diabetic Neuropathy at Society for Neuroscien...(id in the development of future clinical...),Health

Details of Presentation of IENFD Data from SB-509-601 Study

Tuesday, October 20, 2009

• "Epidermal nerve fiber density and regeneration with vascular endothelial growth factor zinc finger protein activator (SB-509) in mild to moderate diabetic peripheral neuropathy patients. (SB-509-0601 study)." M. Polydefkis(1), P. Haurei(1), *E. Benaim(2), D. Ando(2), S. Hamilton(2), H. Kim(2), S. Study Group(2); (1) Johns Hopkins Univ., Baltimore, MD; (2) Clin. Affairs, Sangamo BioSciences, Richmond, CA
  

IENFD and IENFD Regrowth (IENFDR) measurements were prospectively defined endpoints in Sangamo's double-blind, repeat dosing Phase 2 clinical study (SB-509-601) in which subjects were treated at 0, 60 and 120 days. Evaluation of SB-509 treatment on IENFD and IENFDR was carried out in collaboration with Michael Polydefkis, M.D., Associate Professor of Neurology, Johns Hopkins University Medical School and funded by a grant from the Juvenile Diabetes Research Foundation (JDRF).

IENFD derived from 3mm skin punch biopsies taken from the thigh at baseline (Day 0) and thirty days after the final treatment (Day 150) were obtained from both SB-509 and placebo treated subjects. In addition, IENFDR was determined by applying a capsaicin patch to the skin of the thigh to produce a standardized nerve injury on Days 150 and 151 and using serial skin biopsies over time, post capsaicin treatment, up to Day 360, to determine nerve regrowth in both SB-509 and placebo-treated subjects.

In SB-509 treated subjects an increase in mean change in nerve fiber density from baseline was observed compared to a decrease for placebo treated subjects (p-value = 0.02). Importantly, a rank sum analysis of these data
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