Argos Therapeutics Announces First Patient Dosed in Stage 2 of Adult Eradication Trial of AGS-004 in the Treatment of HIV
July 14, 2016 at 08:30 am
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Argos Therapeutics, Inc. announced that the first patient has been dosed in the second stage of the ongoing investigator-initiated Phase 2 adult eradication clinical trial of AGS-004, the company's investigational immunotherapy for the treatment of human immunodeficiency virus (HIV) infection, in combination with the latency-reversing drug, vorinostat. This second stage study, being funded by a federal research grant from the Division of AIDS of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, is being conducted at the University of North Carolina, Chapel Hill. Eliminating the latent virus reservoir is an essential treatment goal in efforts to eradicate HIV infection. Research has shown that histone deacetylase (HDAC) inhibitors, like vorinostat, can reverse latency by activating latently infected cells, potentially allowing them to then be targeted by the immune system. This is the first clinical trial evaluating the "kick and kill" approach employing a validated HIV latency-reversing drug combined with an individualized immunotherapy. In the trial, HIV-infected patients are being given latency-reversing therapy with the HDAC inhibitor vorinostat in combination with the immunotherapy, AGS-004. “This study will test whether combining AGS-004 treatment with a latent virus reservoir mobilizer can lead to the elimination of HIV-infected cells,” stated Dr. David Margolis of the University of North Carolina, director of the UNC HIV Cure center. The study is expected to evaluate 12 participants who will receive alternating courses of the two agents. Throughout the study, CD8+ T cell responses will be measured along with changes in low level plasma HIV-1 RNA and the frequency of HIV-1 infection of resting CD4+ T cells. All participants will continue antiretroviral therapy (ART) throughout the study.
Argos Therapeutics, Inc. (Argos) is an immuno-oncology company. The Company is focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases based on its technology platform called Arcelis. The Company's Arcelis technology platform utilizes biological components from a patient's own cancer cells or virus to generate individualized immunotherapies. The Company is engaged in the development of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC), and other cancers. It is conducting a pivotal Phase III clinical trial of AGS-003 plus sunitinib or another targeted therapy for the treatment of newly diagnosed mRCC under a special protocol assessment (SPA). It is engaged in the development of AGS-004 for the treatment of Human Immunodeficiency Virus (HIV). It has conducted over three clinical trials of AGS-004, including a Phase IIb clinical trial, Phase IIa clinical trial and Phase I clinical trial.