A single injection of a novel CRISPR gene-editing treatment safely and efficiently removes SIV -- a virus related to the AIDS-causing agent HIV -- from the genomes of non-human primates, scientists now report. The groundbreaking work complements previous experiments as the basis for the first-ever clinical trial of an HIV gene-editing technology in human patients, which was authorized by the Food and Drug Administration (FDA) in 2022.
A single injection of a novel CRISPR gene-editing treatment safely and efficiently removes SIV -- a virus related to the AIDS-causing agent HIV -- from the genomes of non-human primates, scientists at the Lewis Katz School of Medicine at Temple University now report. The groundbreaking work complements previous experiments as the basis for the first-ever clinical trial of an HIV gene-editing technology in human patients, which was authorized by the Food and Drug Administration in 2022.
"The outcome of the preclinical model set the stage for the ongoing clinical trial of EBT-101, which is sponsored and managed by Excision Biotherapeutics, Inc.," he explained. Before clinical trials of EBT-101 could be undertaken in humans, the researchers first collected data on safety from studies in non-human primates. This necessitated the use of a version of EBT-101 adapted to treat SIV infection, which mimics HIV infection in humans but is specific to non-human primates. For the preclinical trial, Dr.
"The long timeframe of the study and the use of high doses of the gene-editing construct help confirm the safety of EBT-001," Dr. Burdo said."Our preclinical work in non-human primates was essential for allowing us to establish the criteria for applying EBT-101 in clinical studies and enabling the FDA authorization for an HIV-specific gene-editing therapy to move forward."
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