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Sangamo BioSciences Completes Phase I Study of SB-509 for Diabetic Neuropathy

Strategic Insights

— 1 min read

Sangamo BioSciences, Inc. has completed subject enrollment and treatment in its phase I study of SB-509, a novel ZFP therapeutic designed to treat diabetic neuropathy by upregulating the expression of vascular endothelial growth factor (VEGF). The study, which evaluated the safety of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy, demonstrated the tolerability of ZFP therapeutics in humans, with no serious adverse events associated with treatment. The company plans to announce results from the study in the first half of 2006 and initiate a phase II clinical study in the second half of the same year.

Key Takeaways:

  • SB-509 is a novel ZFP therapeutic designed to upregulate the expression of VEGF to protect and stimulate the regeneration of peripheral nerve function in diabetics.
  • The phase I study, which enrolled 12 subjects, evaluated the clinical safety of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in both legs.
  • The study demonstrated the tolerability of ZFP therapeutics in humans, with no serious adverse events associated with treatment.
  • Sangamo expects to announce results from the study in the first half of 2006 and initiate a phase II clinical study in the second half of 2006.
  • The company believes that the willingness of physicians and patients to readily accept a new treatment option for diabetic neuropathy is a positive indication of the potential of SB-509.
  • SB-509 has been shown to be effective in protecting motor and sensory nerve function from disease-induced nerve damage in preclinical animal efficacy studies.

Statistics:

  • 12 subjects were treated in the phase I study.
  • Four dose levels of SB-509 were tested in the study.
  • The study had a double-blind, placebo-controlled, single treatment, dose-escalation design.
  • The 6-month follow-up period of the study is ongoing.
  • Sangamo plans to present the data from the trial in the first half of 2006.

Sources:

  • "Sangamo BioSciences Completes Phase I Study of SB-509 for Diabetic Neuropathy," Health & Medicine Week, February 2006.
  • Copyright 2005, Health & Medicine Week via NewsRx.com.

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