SB-509 represents a new approach in treating diabetic neuropathy, designed to directly protect and restore nerve function by up-regulating the expression of the gene encoding vascular endothelial growth factor (VEGF-A) in diabetics suffering from peripheral neuropathy.
In the study, twelve subjects were treated, with SB-509 administered by intramuscular injection in a distribution along the major peripheral nerves in the legs and feet.
All of the safety end-points of the study were met. Adverse events were limited to mild injection site reaction, there were no serious drug-related events, and no dose-limiting toxicities were observed.
In addition, improvements in pain, numbness and neurological symptoms were observed in approximately 50% of subjects who received a single treatment of SB-509.
“Most significantly, we did not observe any dose-limiting toxicity, and we were able to treat subjects within the pharmacologically effective dose range that we had demonstrated to be efficacious in preclinical animal studies,” stated Dr Dale Ando, Sangamo’s vice president of therapeutic development and chief medical officer.
“This is important, as previous therapies designed to halt or reverse the nerve deterioration that is characteristic of this condition had dose-limiting toxicities that prevented testing at dosing proven to be effective and tolerated in animal studies,” continued Dr Ando.