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Topline data from Sangamo's SB-509-601 Phase II clinical trial demonstrated a direct neuroregenerative effect of SB-509 treatment that resulted in a statistically significant (p value=0.02) increase in small unmyelinated nerve fibers in the skin, or intraepidermal nerve fiber density (IENFD), in subjects with DN, the company said.
Data were also presented by the company that provided additional evidence of the positive effect of SB-509 on large fiber sensory nerve health as measured by improvements in nerve conduction velocity (NCV), in subjects with elevated markers of vascular damage (ICAM-1), and improvements in the muscle components of the neurologic exam (NIS-LL) 30 days after each of the three administrations of SB-509, said Sangamo.
Together these data confirm the neuroregenerative activity of SB-509 in patients with DN and define a drug-responsive population for future trials.
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, according to Sangamo.
Dale Ando, vice president of therapeutic development and chief medical officer at Sangamo BioSciences, said: "The IENFD data presented provide direct histologic evidence of nerve regrowth with SB-509 treatment and a mechanistic proof of concept for the neuroregenerative effects of this ZFP Therapeutic. The relationship between reduced IENFD and severity of DN has been well established and correlates with decreased levels of vascular endothelial growth factor-A and an increase in inflammatory growth factors such as ICAM-1, a marker of vascular disease."
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