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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