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Sangamo BioSciences Initiates Phase 2 Clinical Trial Of ZFP Therapeutic In Stem Cell Mobilization

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced the initiation of a randomized, single-blind, placebo-controlled, multi-center Phase 2 clinical trial in subjects with mild to moderate diabetic neuropathy (DN). The study is designed to evaluate the pharmacokinetics of stem cell mobilization into the bloodstream after treatment with varying doses of SB-509 as well as the clinical safety and clinical effects of SB-509 administration.

"In addition to Phase 1 clinical data that suggest neuroprotective, neuroregenerative and angiogenic effects of SB-509, we have preclinical and preliminary clinical data that suggest that treatment with SB-509 can mobilize stem cells into the circulation," stated Dale Ando, Sangamo's vice president of therapeutics and chief medical officer. "Stem cells are of interest as potential therapeutic agents as they can be induced to become cells with a special function in the body such as nerves and blood vessels and can potentially migrate from the blood circulation into areas of injury or degeneration to participate in the body's repair response. The stem cells that have been observed post treatment with SB-509 are highly enriched in cell types that mediate tissue repair. In addition, early data suggests that SB-509 treatment may mobilize between 100 to 1000-fold more cells than are typically being introduced into subjects in many of the ex vivo stem cell therapeutic approaches that are currently being tested. Ultimately, this phenomenon may also serve as a pharmacodynamic surrogate biomarker enabling a physician to easily monitor progress of this therapy for DN after SB-509 administration."

SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF(TM)), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene. Sangamo has already completed enrollment of subjects in a Phase 2 randomized double blind, placebo-controlled, repeat-dosing clinical trial of SB-509 in subjects with mild to moderate DN and has an ongoing Phase 2 clinical trial of SB-509 in diabetic subjects with moderate to severe DN.

"We are very encouraged by the early observations of this novel activity of SB-509 in stem cell mobilization," said Edward Lanphier, President and CEO of Sangamo BioSciences. "We look forward to confirming and expanding these data in this new Phase 2 study. In addition to our Phase 2 program in DN, we are also evaluating our VEGF activating ZFP TF 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) which we expect to initiate later this year."

Supporting Pre Clinical and Clinical Observations

Pre-clinical studies of a VEGF-activating ZFP TF demonstrated statistically significant (p





Sangamo Biosciences iniþiazã Faza 2 studiu clinic Din ZFP terapeutice În celule stem mobilizare - Sangamo BioSciences Initiates Phase 2 Clinical Trial Of ZFP Therapeutic In Stem Cell Mobilization - articole medicale engleza - startsanatate