ROCKVILLE, Md. -- American Gene Technologies (AGT), a leading gene and cell therapy company based in Rockville, MD, selected the Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) as a new clinical site for its non-IND study, AGT-CS168, to collect clinical specimens from HIV positive individuals. AGT will use these materials to validate the patient-specific AGT103-T therapeutic manufacturing process. AGT expects AGT103-T will eliminate HIV from the body when infused back into the patient and will decrease or eliminate the need for lifelong antiretroviral treatment.
The Company’s protocol AGT-CS168 was initiated at Providence Hospital in Washington, D.C., and IHV has been added as a site to extend and complete the study. CEO Jeff Galvin stated, “The Institute of Human Virology at the University of Maryland School of Medicine is a leader in HIV medical research and has developed many innovative technologies. As it is a globally recognized university for HIV research and treatment, AGT is pleased to be working with IHV on this protocol.”
AGT’s protocol utilizes HIV-specific CD4+ T cells that are harvested from HIV patients through leukapheresis. These samples are used to develop and validate the manufacturing process for AGT103-T, a gene-modified cell product made from the participants’ own cells. During the upcoming Phase 1 study, patient-specific AGT103-T will be infused to evaluate safety and identify biomarkers of clinical responses.
About American Gene Technologies (AGT)
American Gene Technologies (AGT) is a gene and cell therapy company with a proprietary gene-delivery platform to rapidly develop gene and cell therapies to cure infectious diseases, cancers, and monogenic disorders. The Company’s mission is to transform people’s lives through genetic medicines that rid the body of disease. The Company expects to take its patented lead candidate for an HIV cure into the clinic in 2019. AGT has received five patents for its unique immuno-oncology approach to stimulate the human body’s natural immune system’s gamma-delta (γδ) T cells to destroy a variety of solid tumors. The Company has also developed a synthetic gene which it expects to cure Phenylketonuria (PKU), a debilitating rare disease. AGT’s treatment for PKU has been granted an Orphan Drug Designation by the Food and Drug Administration (FDA) and it is expected to reach the clinic in 2020.
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