FDA clears IND application for cell therapy to treat HIV
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The FDA cleared an investigational new drug application for AGT103-T, an autologous, genetically modified cell therapy for the treatment of HIV, according to the agent’s manufacturer.
The clearance allows a phase 1 trial to begin for AGT103-T (American Gene Technologies) a lentiviral vector-based gene therapy given as a single IV dose.
“I am confident AGT103-T will be an important step toward an eventual cure for HIV,” Jeff Galvin, founder and CEO of American Gene Technologies, said in a company-issued press release.
AGT103-T was developed via a collaborative research agreement with the National Institute of Allergy and Infectious Disease. Preclinical research has demonstrated the ability to manufacture a product of modified HIV-specific CD4 T cells that resist infection and depletion by HIV in mouse models. AGT103-T has shown the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells, according to the manufacturer.
"This is momentous news that we have FDA approval to launch phase 1 and conduct our first human trials. We are beyond excited to reach this milestone,” David Pauza, PhD, chief science officer of American Gene Technologies, said in the release. “This brings us closer to our goal of transforming lives with genetic medicines.”
American Gene Technologies expects to begin enrollment for the phase 1 trial in September. The first-in-human trial will evaluate the safety of AGT103-T, in addition to measuring key biomarkers and surrogate markers of the agent’s efficacy.
Study sites will be in the Washington, D.C., and Baltimore areas and initially will include Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University. The manufacturer anticipates reporting initial data from the trial before the end of the year.
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