~"GeoVax Vaccine To Be Used in a Phase-1-Trial of Genetically Modified Autologous Cell Therapy for HIV" $$$$$$$$$
ATLANTA, GA, Oct. 24, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – GeoVax Labs, Inc. (GOVX) announced today its participation in a planned clinical trial led by researchers at American Gene Technologies (AGT) (www.americangene.com), to develop a therapy aimed at eliminating HIV from infected people.
On October 18, 2019, AGT announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AGT’s lead HIV program, AGT103-T, a lentiviral vector-based gene therapy. Upon clearance by the FDA, this IND will allow AGT to initiate a Phase 1 clinical trial that will investigate the safety of AGT103-T in humans, measure key biomarkers, and explore surrogate markers of efficacy. AGT expects to begin recruiting patients for the Phase 1 study in January.
Pursuant to its collaboration agreement with AGT, GeoVax will provide its novel MVA-VLP HIV vaccine (MVA62B) for evaluation in an arm of the clinical trial in combination with AGT103-T. T cells obtained from vaccinated individuals will be reprogrammed by AGT’s lentivirus vector and infused back into the study participants as a therapeutic cell product. MVA62B is the boosting component for GeoVax’s preventive HIV vaccine (GOVX-B11) which has successfully completed a Phase 2a clinical trial and is awaiting funding in support of a Phase 2b pivotal trial.
Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “In a previous therapeutic Phase 1 clinical trial conducted by GeoVax, we demonstrated that our vaccine can potently stimulate production of both CD8+ and CD4+ T cells in HIV-positive individuals – the intended use of the MVA62B vaccine in the proposed AGT therapeutic study. Our vaccine also has a well-documented safety profile in >500 humans. We are hopeful that the combination of technologies in these studies will yield a promising regimen that eliminates the HIV reservoir from people infected with the disease in the absence of antiretroviral drugs.”
David Dodd, GeoVax’s President and CEO, stated, “Finding a cure for HIV/AIDS remains an elusive but critical goal, and GeoVax is pleased to be a contributor to this important effort. While current antiretroviral therapy is effective at suppressing the viral load of HIV-infected individuals and preventing progression to AIDS, the long-term use of ART can lead to loss of drug effectiveness and can come with severe side effects. Additionally, the financial burden of drug and other medical costs to both the individual and to society at large is staggering, with average lifetime medical costs of treating an HIV-positive individual in the U.S. estimated to exceed $350,000.”
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