ROCKVILLE, Md., July 15, 2021 (GLOBE NEWSWIRE) — American Gene Technologies (AGT) announced today that the Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV cure program without modification, after safety analysis of the participant’s data revealed no adverse effects from the treatment. AGT’s Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease, is designed to induce durable viral suppression by delivering therapeutic genes to the recipient’s immune cells. The cells are collected by leukapheresis, modified outside the body, then re-infused. Once infused, the cells are expected to durably suppress the virus at undetectable levels without the need for antiretroviral treatment.
“Safety represents a critical milestone in the project and gives us additional confidence that HIV can be cured,” said Jeff Galvin, CEO. “This milestone supports AGT’s mission to relieve suffering and premature death from serious human diseases. AGT’s HIV cure program is based on a platform that has the capacity to treat other chronic viral infections, as well as monogenic disorders and cancers. Our ImmunoTox program has yielded pre-clinical data showing the potential for revolutionizing solid tumor cancer treatment, and our Phenylketonuria gene therapy may be a one-and-done cure for patients suffering from that inherited disease. A success in HIV would provide sustained funding to accelerate dozens of therapeutics that are within the scope of AGT’s technology platform.”
Phase 1 in the Maryland/DC Area
AGT’s Phase 1 RePAIR (Restore Potent Antiviral Immune Responses) trial for AGT103-T is currently underway at trial sites in the Maryland / Washington, DC area. The recruitment status of the clinical trial, and information on the trial sites can be found on ClinicalTrials.gov under the identifier NCT04561258. The RePAIR trial is the company’s first step in clinical testing of cell and gene therapies for HIV, cancer, and rare diseases.
A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5974095d-71d8-43f3-b463-466b9714854e
Today, approximately 37.9 million people worldwide, including 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 and 1.7 million individuals globally were newly 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 a rate of 46 new infections per year per 100,000 population and Baltimore City has similarly high rates of 45 new infections 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 prevented AIDS, HIV transmission, and mortality in persons living with HIV and, in some cases, have been used prophylactically 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. When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected. AGT’s approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells. AGT’s AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment.
About American Gene Technologies
American Gene Technologies (AGT) is a clinical-stage cell and gene therapy company focusing on treatments and cures for viral infections, acquired or inherited diseases, and cancer. Operating in Rockville, MD, AGT designs, develops, and tests novel genetic medicines using a gene-delivery platform that accelerates early-stage testing and enables rapid translation to the clinic. The company has an extensive patent portfolio covering gene therapies for HIV disease, Phenylketonuria (PKU), and solid tumor forms of epithelial cancer.
For more information on AGT’s Phase 1 clinical trial, visit clinicaltrials.gov (Study Identifier: NCT04561258).
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