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Sangamo BioSciences Announces Presentation of Clinical Data Demonstrating Functional Control of Viremia in HIV-Infected Subjects Treated with SB-728-T
Date:9/12/2013

are generally not susceptible to the most common strain of HIV.

Summary of Clinical Trial Design
About SB-728-902 Cohorts 1-3
The study is an open-label Phase 1 clinical trial to evaluate the safety and tolerability of single infusions of an escalating dose of an autologous (a patient's own) CD4+ T-cell product genetically modified at the CCR5 gene by CCR5-specific ZFNs (SB-728-T). The trial enrolled nine HIV-infected subjects (three cohorts of three subjects each) who have sub-optimal T-cell levels and no detectable viral load on long-term ART.  Subjects remained on their existing antiviral therapy while receiving treatment with SB-728-T.

About SB-728-902 Cohort 5
Up to 20 HIV-infected subjects heterozygous for the CCR5 delta-32 mutation (i.e. with one CCR5 gene that is naturally modified) who are currently on ART are being enrolled and will receive a single intravenous infusion of SB-728-T (5 to 30 billion modified cells). Two months after SB-728-T treatment, subjects undergo a 16 week TI during which time their ART is discontinued. ART will be reinstituted in subjects whose CD4 T-cell counts drop to <350 cells/ mm3 and/or whose HIV-RNA increases to >100,000 /mL for three consecutive weekly measurements. At the end of the TI, subjects with a sustained detectable HIV viral load are reinstituted on ART. Subjects with an undetectable viral load can remain off ART until HIV RNA levels are detectable or their CD4 T-cell count drops below 350 cell/mm3 for three consecutive weekly measurements.

A total of ten subjects have been treated in this cohort. 

Of the six evaluable subjects, we observed two subjects in which their VL became undetectable during TI from ART:

  • In one subject, VL suppression at, or below, the limit of quantification (LOQ) of virus was sustained from week 11 – 19 of TI and the TI is ongoing.
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SOURCE Sangamo BioSciences, Inc.
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