Argos Therapeutics Phase 2 Trial In HIV Fails To Achieve Primary Goal

(RTTNews) - Argos Therapeutics Inc. (ARGS) Friday announced top-line results of its double-blind, placebo-controlled Phase 2b clinical trial of AGS-004, the company's investigational fully personalized immunotherapy for the treatment of HIV, in patients chronically infected with HIV-1.

The primary endpoint of the trial, which required a 1.1 Log lower median viral load or VL after 12 weeks of interruption of antiretroviral therapy or ATI in the treatment group versus the placebo group, was not achieved.

However, data showed evidence of the ability of AGS-004 to induce memory T-cell responses which may have directly impacted the latent viral reservoir.

Of the patients who received AGS-004 and completed ATI, around 70 percent had positive antiviral memory T-cell responses prior to ATI compared to zero percent of placebo patients.

Also, within the AGS-004 treatment group, those patients that had antiviral memory T-cell responses had significantly fewer CD4+ T-cells with integrated HIV DNA when compared to non-responders.

In the Phase 2b trial, 54 patients received four doses of AGS-004 or placebo every four weeks while on standard antiretroviral therapy or ART, and then began a 12-week ATI, during which dosing continued every four weeks. In total, 36 participants completed ATI, 23 of whom received AGS-004.