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Sangamo plans study of diabetes drug

San Francisco based biotech Sangamo BioSciences has revealed plans to begin a phase II clinical trial of its novel ZFP Therapeutic SB-509 in patients with mild to moderate diabetic neuropathy.

SB-509 is designed to upregulate 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.

Sangamo is proposing to undertake a placebo-controlled, multi-treatment phase II study in diabetic participants with mild to moderate sensory/motor neuropathy. Participants will be assigned to one of three treatment groups to be given either a placebo, SB-509 every two months for three treatments, or SB-509 every three months for three treatments.

Those receiving SB-509 will be treated with the maximum tolerated dose by intramuscular injection in both legs. Safety will be monitored throughout the study. Clinical evaluations will include neurological examination and electrophysiological testing. The study will be conducted at multiple centers. Participant enrollment is expected to take approximately twelve months.

“The progression of our first ZFP Therapeutic program into phase II clinical trials is a significant clinical development milestone for Sangamo,” said Mr Edward Lanphier, Sangamo’s president and CEO. “We are on track to initiate the phase II study of SB-509 in the second half of 2006.”

No adverse drug-related events were observed during a phase I study of SB-509. Results of this study are due to be presented at a scientific meeting this April.