The trial is designed to evaluate clinical safety of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in both legs. Twelve subjects have been treated in the trial, all of whom received treatment in one leg and placebo in the other.
Either SB-509 or the placebo was administered by injection in a distribution that targets the major peripheral nerves in the legs and feet. Four dose levels of drug were tested. Safety will be monitored throughout the study, and visits at one, two, three and six months include neurological examination and electrophysiological testing.
Sangamo expects to announce results from this study in the first half of 2006 and to initiate a phase II clinical study in the second half of 2006.
SB-509 is a novel ZFP therapeutic designed to up-regulate the expression of the patient’s own vascular endothelial growth factor (VEGF) gene to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy.
“The current standard of care for these patients addresses only their symptoms with pain medications and antidepressants,” said Dr Dale Ando, Sangamo’s vice president of therapeutic development and chief medical officer. “In contrast, our ZFP therapeutic has the potential to protect and stimulate the regeneration of peripheral nerves damaged by the build up of toxic metabolites in diabetes.”