Sangamo begins phase 1 trial of SB-509 in diabetic neuropathy

By Angela McDaniels

Seattle, Nov. 30 - Sangamo BioSciences Inc. said it has completed subject enrollment and treatment in its phase 1 study of SB-509 in subjects with mild to moderate diabetic neuropathy.

This single blind, placebo-controlled, single treatment, dose-escalation 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 through injection in one leg and placebo in the other.

Safety will be monitored throughout the study, and visits at one, two, three and six months will include neurological examination and electrophysiological testing.

"This is the first demonstration of the tolerability of ZFP Therapeutics in man. We are pleased to report that we did not observe any serious adverse events associated with treatment in this phase 1 study," said Dale Ando, Sangamo vice president of therapeutic development and chief medical officer, in a company news release.

"We have been able to recruit subjects to this study at a faster rate than anticipated and believe that this is a good indication of the willingness of physicians and patients to readily accept a new treatment option for this debilitating complication of diabetes. The current standard of care for these patients addresses only their symptoms with pain medications and antidepressants.

"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 [patients]."

Sangamo expects to announce results from this study in the first half of 2006 and to initiate a phase 2 clinical study in the second half of 2006.

SB-509 is a ZFP Therapeutic administered as an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF) designed to upregulate the expression of a patient's vascular endothelial growth factor gene, thereby protecting and stimulating the regeneration of peripheral nerve function.

In preclinical animal efficacy studies in a diabetic rat model, SB-509 has proven effective in protecting motor and sensory nerve function from disease-induced nerve damage, the company said.

Diabetic peripheral sensory motor neuropathy is one of the most frequent complications of diabetes, the company said. Patients gradually lose sensation and motor function as nerve damage progresses. More than 60% of non-traumatic lower-limb amputations in the United States occur among people with diabetes.

Sangamo is a biotechnology company based in Richland, Calif., that develops DNA-binding proteins for therapeutic gene regulation and modification.

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