ROCKVILLE, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- American Gene Technologies (AGT) announced today that the first trial participant was enrolled in the Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease. The first trial participant underwent leukapheresis, a procedure for obtaining concentrated white blood cells, which will be used for manufacturing the AGT103-T cell product. After manufacturing and required safety testing, the product will be infused back into the trial participant to test product safety and effects on the immune system.
Phase 1 in the Maryland/DC Area
Enrollment of the first trial participant signals the start of AGT’s Phase 1 trial for AGT103-T and the company’s first step in clinical testing of cell and gene therapies for HIV and other diseases. The AGT103-T clinical trial is being conducted at sites in the Washington, DC metropolitan area starting with the Washington Health Institute in the District of Columbia. More information about participation and trial sites can be found at ClinicalTrials.gov.
Today, approximately 37.9 million people worldwide and 1.2 million people in the United States are living with HIV/AIDS. The U.S. government has estimated that 38,900 Americans were newly infected with HIV in 2018 and 1.7 million individuals globally were infected with HIV in 2018. Locally, the Washington D.C./Baltimore area is often cited as a ‘hot spot’ for HIV with Washington, D.C. having the highest rate of infection at nearly 48 infections per 100,000 population and Baltimore City with similarly high infection rates of 36 per 100,000. Maryland also ranks fifth among U.S. states and territories in HIV diagnosis rates, with nearly 1,000 new cases in 2018 alone, according to the Maryland State Department of Health.
Since the late 1980s, antiretroviral drugs have restored quality of life to persons living with HIV and, in some cases, have even been used to prevent new infections. However, no approved treatments can cure HIV. AGT is committed to addressing this unmet medical need.
AGT103-T is a genetically modified cell product made from a person's own cells. AGT's approach is unique in that it focuses on repairing the key immune system damage caused by HIV. AGT’s goal is to develop a cell and gene therapy capable of repairing the immune system so it will provide natural control over HIV replication.
About American Gene Technologies
AGT is a gene and cell therapy company with a proprietary gene-delivery platform for rapid development of cell and gene therapies to cure infectious diseases, cancers, and inherited disorders. AGT's mission is to transform people's lives through genetic medicines that rid the body of disease. AGT has received 3 patents for the technology used to make the AGT103-T cell product and ten patents for its unique immuno-oncology approach to stimulate gamma-delta (γδ) T cells to destroy a variety of solid tumors. The company has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. AGT's treatment for PKU has been granted Orphan Drug Designation by the Food and Drug Administration (FDA), and it is expected to reach the clinic in 2022.