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Sangamo BioSciences Initiates Phase 2 Clinical Trial of Treatment for Amyotrophic Lateral Sclerosis (ALS)
Date:9/3/2008

ic," stated Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer. "The drug is designed to activate the expression of the subject's own VEGF-A gene. There is mounting pre-clinical and clinical evidence to support a correlation between reduced VEGF-A levels and progression of this life-threatening disease. Our Phase 1 clinical studies of SB-509 in diabetic neuropathy have shown that the drug is well tolerated. Data from this clinical study and pre-clinical studies in animal models of nerve damage reveal positive effects of SB-509 on motor nerve function and muscle composition. Similar effects on motor nerves and muscles in these patients may slow the progression of ALS by preserving nerve function and improving muscle fiber composition and strength."

The Phase 2 trial (SB-509-801) is a randomized repeat-dosing, open-label, multi-center study designed to evaluate the effect of intramuscular administration of SB-509 on the progression of the disease in subjects with ALS, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) a validated rating instrument for monitoring the progression of disability in patients with ALS. Efficacy of SB-509 will be evaluated by comparing the rate of ALS disease progression in subjects treated with SB-509 in this study to historical placebo controls. In addition to gathering data on safety and tolerability of SB-509 in subjects with ALS, data will be collected to evaluate the effect of SB-509 on additional clinical measures. These measures include Forced Vital Capacity (FVC), a test of lung function; Neurophysiologic Index (NI), a measure of neurologic impairment; Manual Muscle Test (MMT), a test of muscle strength; and survival. Finally, the study will also evaluate stem cell mobilization in subjects with ALS receiving SB-509.

"We are pleased to meet our goal of beginning a Phase 2 clinical trial in ALS this year and are very excited to begin these proof of principle stud
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SOURCE Sangamo BioSciences, Inc.
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