Sangamo BioSciences Announces Presentation Of Phase 1b ZFP Therapeutic Data At Society For Neuroscience Meeting
November 7, 2007 – 4:05 pm | posted in Neurology / NeuroscienceSangamo BioSciences, Inc. (Nasdaq: SGMO) announced the presentation of additional Phase 1b clinical data from its ZFP Therapeutic(TM) program at Neuroscience 2007, the 37th annual meeting of the Society for Neuroscience. The data demonstrate statistically significant improvements in quantitative measurements of neurological health in subjects with diabetic neuropathy (DN), suggesting an alteration of disease progression.
Additional data were presented suggesting that a single treatment with SB- 509 may increase the mobilization of stem cells into a subject’s blood. These circulating stem cells may have implications for the nerve regeneration and nerve and blood vessel growth that have been reported from SB-509 treatment. Sangamo plans to further investigate this observation and evaluate the kinetics of mobilization in a new Phase 2 trial that the Company expects to initiate in the first quarter of 2008 in subjects with mild to moderate DN.
“The data obtained in this clinical trial demonstrate that, six months after a single treatment, SB-509 appears to have not only a neuroprotective but also possibly a neuroregenerative effect,” commented the presenter, Dale Ando, M.D., Sangamo’s vice president of therapeutic development and chief medical officer. “We are very pleased with these data. We are also excited by the observation of mobilization of aldehyde bright stem cell into the blood stream of subjects with diabetic neuropathy after a single treatment with SB-509. VEGF ZFP TF(TM) treatment appears to mobilize between 100 and 1000-fold more stem cells than are typically being introduced into patients in many of the stem cell therapeutic approaches that are currently being tested.
We believe that exploring this observation of natural mobilization of stem cells in a new Phase 2 trial in subjects with diabetic neuropathy may provide us with valuable mechanistic data that could aid in the ultimate development of this product for a number of neurological and vascular indications. In addition, this may provide us with a pharmacodynamic surrogate biomarker that enables easy monitoring of the response of subjects to SB-509.”
SB-509 is a formulation of a zinc finger DNA-binding protein transcription factor (ZFP TF) designed to upregulate the expression of the gene encoding vascular endothelial growth factor (VEGF-A). Sangamo is currently evaluating SB-509 in two ongoing Phase 2 clinical trials for the treatment of diabetic neuropathy.
“We continue to be very pleased and impressed by the disease-altering improvements that we have observed in several measurements of nerve health in subjects with mild to moderate diabetic neuropathy treated with SB-509,” said Edward Lanphier, President and CEO of Sangamo BioSciences. “We are also very excited to be evaluating SB-509 in models of spinal cord injury, traumatic brain injury, and in a major new initiative, a Phase 2 clinical trial in Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease). We will provide more details about trial design and timing for both our stem cell mobilization and ALS Phase 2 trials at our Analyst Briefing in early December.”
Clinical Results Presented at Neuroscience 2007
The data presented at the Society for Neuroscience meeting were collected from subjects with mild to moderate diabetic peripheral neuropathy enrolled in Sangamo’s Phase 1b study of SB-509. Subjects received a single treatment in both legs of either placebo (10 subjects) or SB-509 (10 subjects who received 60 mg total dose or 30 mg per leg). All of the subjects completed six-month follow-up testing. Clinicians observed statistically significant clinical improvements in quantitative sensory testing (QST) which quantifies perception of vibration. Specifically, mean QST testing compared to baseline in SB-509 treated patients showed a 25.9% improvement compared to 5.4% worsening in the placebo group (a delta in QST of 31.3%, p
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