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news.Sangamo BioSciences has initiated a phase II clinical trial of its drug for subjects with moderate to severe diabetic peripheral sensory motor neuropathy.
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The clinical trial is designed to evaluate the safety and clinical effects of repeat administration of SB-509 in diabetic subjects that have unmeasurable nerve conduction velocity (NCV) in at least one of the nerves in the leg. Sangamo also has an ongoing phase II trial of SB-509 in subjects with mild to moderate diabetic neuropathy (DN).
“In our phase I studies we noted interesting clinical improvements in a number of subjects and have initiated this phase II trial to follow up on those observations,” said Dale Ando, Sangamo’s vice-president of therapeutic development.
“In addition to improvement in total neuropathy score and quantitative sensory testing, three subjects with so-called “blocked nerves” or unmeasurable nerve conduction velocity measurements in the leg showed recovered and improved NCV over a six-month follow-up period after a single treatment with SB-509.”
The primary objective in this phase II study will be to determine the effect of SB-509 on the clinical profile of neurologic damage in association with DN and the potential effects on nerve regeneration or regrowth.
Currently, patients with DN are treated with analgesics and antidepressants to control pain symptoms. In contrast, SB-509 is designed to address the actual nerve damage and therefore could have a impact on the lives of patients suffering with diabetic neuropathy.