"These data, and other clinical and preclinical observations of natural mobilization of stem cells in a response to our ZFP activator of VEGF, are very interesting and form the basis of our most recently initiated Phase 2 study (SB-509-703)," commented Dale Ando, M.D. Sangamo's vice president of therapeutic development and CMO. "In this Phase 2 clinical trial we are monitoring changes in the numbers of stem cells in the circulation of subjects with mild to moderate diabetic neuropathy after treatment with our ZFP Therapeutic. We believe that the study may provide us with valuable pharmacodynamic data on the relationship between stem cell mobilization and treatment."
Clinical Results Presented at the ISCT Meeting
The data presented at the ISCT meeting on Sunday, May 18, 2008, were collected from a single arm, open-label, Phase 1 clinical trial in subjects (n=20) with critical limb ischemia (Rutherford Grade 4/5). Qualifying subjects were assigned to receive dose-escalating, intra-muscular injections of ZFP-VEGF in the ischemic leg (index leg). Subjects were clinically classified as significant responders, minimal responders or non-responders based on their tissue oximetry readings. Circulating progenitor cells were measured and quantitated by FACS analysis based on aldehyde dehydrogenase activity (ALDH+) and expression of CD34 in 11 subjects. These measures were subsequently compared with clinical outcomes. Additionally, bone marrow samples from 8 patients were evaluated for ALDH+ cells on Day 0 and Day 12 post treatment to determine the effects of ZFP-VEGF on progenitor cell mobilization.
Clinicians observed a mean increase in circulating CD34+/ ALDH + cells
of 1.3 fold from Day 0 to Day 30 post-treatment and 1.9 fold from Day 0 to
Day 90 post-treatment. In addition, subjects with 7 to 9 fold increases in
bone marrow stem cells were also the best clin
|SOURCE Sangamo BioSciences, Inc.|
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