ARGOS LAUNCHES TRIAL OF PERSONALIZED IMMUNOTHERAPY

Argos Therapeutics has announced the initiation of a Phase I/II clinical trial to test the immunologic activity and safety of its AGS-004 in HIV-infected adults. The target population for the study is patients with durable viral suppression from highly active antiretroviral therapy (HAART). AGS-004 is a personalized RNA-loaded dendritic cell-based immunotherapy that is designed to stimulate the patient's immune system to target and destroy the patient's own unique viral burden.

"Non-personalized HIV immunotherapies are unable to raise cytotoxic T lymphocytes against HIV antigens, fail to induce T-cell memory, and, most importantly, do not provide antiviral protection against the patient's own particular virus," Jean-Pierre Routy, the principal investigator and sponsor of the study, said. "A personalized immunotherapy addresses these issues because it is able to capture private viral mutations, providing a matched, complete immune response for each individual HIV patient."

Ten patients with HIV who are on HAART will be enrolled in the trial. The primary study objective is to evaluate patient-specific antiviral response to the AGS-004 immunotherapeutic following four doses over four weeks. Secondary trial objectives are to evaluate its safety, additional immune induction profiles and the feasibility of production of AGS-004. The development of AGS-004 is part of Argos' broad collaboration with Kirin Brewery's Pharmaceutical Division.