Date: 2016-07-14
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Argos Therapeutics (USA - NC)
Product: AGS-004 and vorinostat
Action
mechanism: cell therapy/immunotherapy product/gene therapy/histone deacetylase inhibitor. AGS-004 is an investigational immunotherapeutic product that consists of autologous dendritic cells co-electroporated with in vitro transcribed RNA encoding four of the patient's own HIV antigens. Vorinostat is an histone deacetylase inhibitor.
Disease: HIV infection
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On July 14, 2016, Argos Therapeutics 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. 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.
