Analysis of Subjects with Moderately Severe Diabetic Neuropathy Shows Statistically Significant Improvement in Multiple Quantitative Neurological Endpoints

RICHMOND, Calif., June 8 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today the presentation of as yet unreleased positive Phase 2 clinical data from its ZFP Therapeutic(TM) program to develop SB-509 as a treatment for diabetic neuropathy (DN) at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA), held in New Orleans, LA, from June 5 to 9, 2009. Data from Sangamo's SB-509-601 and SB-509-701A Phase 2 clinical trials demonstrated that SB-509 treatment resulted in statistically significant and clinically relevant improvements in subjects with moderate and severe DN as compared to placebo. SB-509 was well-tolerated in both multi-dose studies.

'We have learned a great deal from these data, which demonstrate positive activity of SB-509 in multiple clinically relevant measurements of nerve health,' stated Dale Ando, M.D., Sangamo's Vice President of Therapeutic Development and Chief Medical Officer. 'Data from our Phase 1 and both Phase 2 clinical trials have shown us that the dual angiogenic and neurotrophic effects of SB-509 are most effective in the later stages of DN when both diabetic microvascular disease and metabolic neuropathy are evident. The statistically significant improvement in SB-509-treated subjects across multiple independent clinical endpoints for DN has enabled definition of a responder group and is particularly encouraging for future trials in this patient population.'

'SB-509 is the first drug candidate of its type designed to harness the body's own regenerative potential to address DN, a significant complication for diabetic patients,' stated Alan Lewis, Ph.D., President and Chief Executive Officer of the Juvenile Diabetes Research Foundation (JDRF). 'A significant part of JDRF's patient-centric funding efforts support the development of therapies to stop or reverse the impact of diabetic complications and we are very pleased to be involved in the SB-509-601 study with Sangamo. Additionally, JDRF funded an ancillary study by Dr. Polydefkis to investigate the effects of SB-509 on nerve fiber density improvement and nerve regeneration. We are very encouraged that SB-509 was associated with an improvement in clinical outcomes in the more severely affected subjects in the trial and that this group showed increased nerve fiber density and nerve regeneration. In future trials we hope these important and encouraging positive effects of SB-509 are reproduced on a broad range of clinically relevant endpoints and translate into real functional gains for people with diabetes.'

SANGAMO ABSTRACTS PRESENTED AT THE ADA MEETING

Details of Poster Presentation of Data from Sangamo's SB-509-601 Study (Abst# 859-P): 'Vascular Endothelial Growth Factor Zinc Finger Protein Activator (SB-509) in Mild to Moderate Diabetic Peripheral Neuropathy Patients. Interim Phase 2 Results (SB-509-0601 Study)' presented on Saturday, June 6 at 11:30 am CT (12:30 pm ET).

Overall, no difference was seen at 180 days between placebo and SB-509-treated subjects in Sangamo's double-blind, repeat dosing Phase 2 clinical study of SB-509 (SB-509-601) in the following measures of nerve health and function: Abbreviated Neuropathy Impairment Score in the Lower Limbs (A-NIS-LL), Nerve Conduction Velocity (NCV), and Quantitative Sensory Testing (QST). However, analysis of the data demonstrated that subjects entering the SB-509-601 trial had significantly milder DN by neurologic exam (A-NIS-LL) and NCV than subjects in either the Phase 1 SB-509-401 or Phase 2 SB-509-701 studies (p value = 0.0001). Further analysis of the data revealed that subjects with moderate to severe DN had a statistically significant and clinically relevant positive response to treatment with SB-509 over the six-month test period.