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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

ts that had initiated TI in the SB-728-902 Cohort 5 study and an additional CCR5 delta-32 heterozygote subject from an earlier Phase 1 clinical trial of SB-728-T. One SB-728-902 Cohort 5 subject, who had the highest levels of estimated biallelically modified cells and measurable immunological responses to the virus (polyfunctional anti-gag response), demonstrated sustained control of VL at or below the limits of detection, which is ongoing for more than 20 weeks into the TI.

The SB-728-1101 study aimed to demonstrate enhanced engraftment of SB-728-T modified CD4 cells following cyclophosphamide (Cytoxan) preconditioning. 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. This study was successful in showing a Cytoxan-dose dependent increase in both SB-728-T and total CD4 T-cells at the beginning of the treatment interruption, which in the top dose tested (1g/m2) approached the engraftment levels observed in CCR5 delta 32 heterozygote VL responders, and resulted in up to a two-log decrease in VL in one of three subjects who remains on TI and a 0.8-log decrease in a second subject. In the study, a total of twelve subjects were treated in three cohorts of escalating doses of Cytoxan (three subjects at 200 mg, six subjects at 500 mg/m2and three subjects at 1000 mg/m2). All doses tested were safe and well-tolerated although two of the first three subjects in the second cohort experienced Grade 2 nausea, which was reversed using an improved anti-emetic regimen that  was further tested with an additional three subjects (total of six subjects at this dose level). Cytoxan dose-dependent increases were observed in both SB-728-T and total CD4 T-cells. The study has been expanded to test an additional six subjects in two cohorts of three at Cytoxan doses of 2.0 and 3.0 g/
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SOURCE Sangamo BioSciences, Inc.
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