Sangamo expects to present preliminary data in the first half of 2013 and the full data set from both trials by the end of 2013.Data Summary Abstract #126 "The Central Memory T-cell is the Critical Component for Sustained CD4+ Reconstitution in HIV Subjects Receiving ZFN CCR5 Modified CD4+ T-cells (SB-728-T)" Wednesday, March 6, 2013 HIV-infected subjects were enrolled in a Phase 1 clinical trial (SB-728-902, Cohorts 1-3) and received a single dose of SB-728-T (5 to 30 billion cells). All subjects were on ART and had stably controlled undetectable levels of HIV in their blood. The study evaluated safety and tolerability, changes in CD4+ T-cell counts and the ratio of CD4+ to CD8+ T-cells, as well as persistence of SB-728-T in the blood and trafficking of these ZFN-modified cells into gut-associated lymph tissue. Analysis of data from subjects in the study presented today demonstrated:
- Treatment of HIV subjects with SB-728-T leads to both acute and long term increases in total CD4+ T-cell counts.
- Observed level of CD4+ T-cell reconstitution is significantly greater than in previously published T-cell infusion studies without CCR5 modification.
- Long term increases in total CD4+ T-cell counts correlate with increased T CM and increased ZFN-mediated CCR5 disrupted T CM.
- Levels of CCR5 disrupted T CM were stable or increased over time compared to other T-cell sub-populations.
- In addition, analysis of immune cells of treated individuals provided a specific cell-surface marker profile and "gene expression signature" that characterized individuals who showed superior responses to treatment in terms of increased CD4+ T-cell counts.