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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

n used to enhance engraftment of adoptively transferred T-cells in the treatment of cancer and as therapy for numerous autoimmune diseases. The drug has been previously used in HIV-infected individuals and studies demonstrate that, while the drug was transiently lymphodepleting, it did not significantly reduce total CD4 T-cell counts over the long term and was adequately tolerated.

In addition to safety, the study is evaluating the effect of escalating doses of Cytoxan on SB-728-T engraftment, the effect of SB-728-T treatment on viral load following ART interruption, the change in CD4+ T-cell counts in peripheral blood and the long-term persistence of SB-728-T.

By protocol, nine HIV-infected subjects on ART were enrolled into three dose-escalating cohorts (three subjects/cohort), and received intravenous Cytoxan (200 mg, 500 mg/m2 or 1000 mg/m2). In cohort two, an additional three subjects were evaluated on an improved anti-emetic protocol due to an adverse event of Grade 2 nausea observed in two subjects at that dose level. Within each cohort, treatment was staggered so that each subsequent subject was infused with Cytoxan two weeks after the preceding subject. One to three days after receiving Cytoxan, subjects were infused with SB-728-T (8.2 to 36.2 billion cells). Six weeks after SB-728-T infusion, subjects with CD4 cell counts ≥500 cells/mm3underwent a 16 week TI during which time their anti-retroviral therapy was discontinued. ART was reinstituted in subjects whose CD4 T-cell counts dropped to <500 cells/mm3and/or whose HIV-RNA increased to >100,000 copies/ mL for three consecutive measurements.  At the end of the TI, subjects with a sustained detectable viral load >10,000 copies/ mL or CD4 T-cell count <500 cells/mm3 were reinstituted on ART. Subjects with a viral load >10,000 copies/ mL and CD4 T-cell count >500 cells/mm3 can remain off ART until HIV
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SOURCE Sangamo BioSciences, Inc.
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