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All participants in the phase 1 study were on antiretroviral therapy (ART) while receiving the cells with altered CCR5, called SB-728-T; four weeks later, half had their ART therapy
interrupted for 12 weeks to test the effect of the SB-728-T infusion. The NEJM study demonstrates that the modified cells can be safely administered back to the individual; are able to
persist and circulate throughout the body to key reservoirs of HIV infection; and survive longer than unmodified cells when antiviral drugs are withdrawn, potentially keeping the virus under
control without the use of drugs, says senior author Carl June of the University of Pennsylvania in Philadelphia. The person with undetectable viral load after receiving the cell infusion
was later found to have already been carrying a natural mutation of CCR5 (CCR5 delta-32) in one allele.
Sangamo's results reinforce the belief that an immunological approach could control HIV infection and eliminate the need for lifelong antiretroviral therapy, he says. In a second study, a
phase 1/2 trial reported at the Conference on Retroviruses and Opportunistic Infections in Boston on March 6, preconditioning patients with the chemotherapy cyclophosphamide prior to a
single infusion of SB-728-T led to a dose-dependent increase in the engraftment of modified cells and total CD4 cell counts.
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