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Sangamo BioSciences Presents Clinical Data From Key SB-728-T HIV Studies: Proof Of Concept For Ongoing Sustained Functional Control Of HIV Viral Load; Cytoxan Preconditioning Successfully Enhances Engraftment
Date:12/6/2013

lity 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). Nine HIV-infected subjects (three cohorts of three subjects each) classified as immune non-responders (INR) with sub-optimal T-cell levels and no detectable viral load on long-term ART were enrolled into the trial.  Subjects received SB-728-T at doses of approximately 5, 20 or 30 billion cells and remained on their existing antiviral therapy throughout the study without undergoing a TI.
Cohort 5
Ten 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 have been enrolled and have received a single intravenous infusion of SB-728-T (12.6 to 23.5 billion cells). Two months after SB-728-T treatment, subjects underwent a 16 week TI during which time their ART was discontinued. ART was reinstituted in subjects whose CD4 T-cell counts dropped to <350 cells/ mm3 and/or whose HIV-RNA increased to >100,000 /mL for three consecutive weekly measurements. At the end of the TI, subjects with a sustained detectable HIV viral load were reinstituted on ART. Subjects with an undetectable viral load can remain off ART until HIV RNA levels are >10,000 copies/mL for three consecutive weekly measurements or their CD4 T-cell count drops below 500 cell/mm3 for two consecutive weekly measurements.

About SB-728-1101
SB-728-1101 is an open-label, dose escalation, multi-center study designed primarily to evaluate the safety and tolerability of escalating doses of cyclophosphamide (Cytoxan) administered prior to SB-728-T infusion. Cytoxan is a drug that is used to transiently reduce the numbers of T-cells in the body, which then rapidly repopulate once the drug is discontinued, and it is into this "growth" environment that SB-728-T is infused. Such lymphodepletive treatment has bee
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SOURCE Sangamo BioSciences, Inc.
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