Sangamo plans phase 2 trial of ZFP to treat diabetic neuropathy

By Lisa Kerner

Erie, Pa., Jan. 12 - Sangamo BioSciences, Inc. will begin a phase 2 study of SB-509 in the second half of this year, according to a company news release.

The proposed phase 2 clinical trial will be a placebo-controlled, multi-treatment multi-center study in diabetic subjects with mild to moderate sensory/motor neuropathy.

Subjects will be assigned to one of three treatment groups which will be administered a placebo, SB-509 every 2 months for three treatments or SB-509 every 3 months for three treatments. Subjects receiving SB-509 will be treated with the maximum tolerated dose of the ZFP Therapeutic by intramuscular injection in both legs. Clinical evaluations will include neurological examination and electrophysiological testing.

Subject enrollment is expected to take approximately 12 months.

SB-509 is a novel ZFP Therapeutic designed to stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy, according to the release. It is administered as an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor, designed to upregulate the VEGF-A gene. The gene is demonstrated to have neurotrophic and neuroprotective properties.

"The progression of our first ZFP Therapeutic program into phase 2 clinical trials is a significant clinical development milestone for Sangamo," company president and chief executive officer Edward Lanphier said in the release. "We announced completion of enrollment of subjects in the phase 1 study of SB-509 in November and did not observe any drug-related severe adverse events or dose-limiting toxicity."

Preclinical animal efficacy studies in a diabetic rat model have proven SB-509 effective in protecting nerve function from disease-induced nerve damage.

Diabetic neuropathy is a frequent complication of diabetes that can lead to loss of sensation and nerve damage in the legs and feet as well as amputation of infected areas. The American Diabetes Association estimates that there are approximately 18.3 million people with diabetes in the United States. Of that number, about 60% to 70% have mild to severe forms of neuropathy, said the release.

Sangamo outlined its phase 2 plans at the 24th annual JPMorgan Healthcare Conference.

San Francisco-based Sangamo BioSciences is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification.

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