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news.Argos Therapeutics has initiated dosing of patients in a Phase 2b clinical trial of its Arcelis personalized immunotherapy for the treatment of HIV patients, AGS-004.
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The Phase 2b trial is a multicenter, randomized, double-blind, placebo-controlled study in HIV infected patients receiving antiretroviral therapy (ART) to evaluate the efficacy and safety of AGS-004 when compared to placebo during an analytical treatment interruption of ART.
Argos said that the primary objective of the trial is to compare AGS-004 with placebo and the anti-HIV effects of AGS-004 as measured by the new plasma HIV viral load set point established at the end of the 12 week analytical treatment interruption.
A total of 42 patients are expected to be enrolled in the Phase 2b trial.
The data from the Phase 2a trial of AGS-004 demonstrated a substantial reduction in viral load set point during ART treatment interruption compared to pre-ART levels, and an unexpectedly long time to viral rebound after withdrawal of ART.
Argos president and CEO Jeff Abbey said that the Phase 2b trial will further demonstrate that AGS-004 is an effective and safe alternative treatment for HIV patients.
"Our RNA-loaded, dendritic cell-based immunotherapy is perfectly matched to each patient’s unique HIV viral burden, allowing for a remarkable decrease in viral diversity post-AGS-004 treatment," Abbey said.