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Study Results Demonstrate Analytical Treatment Interruption to Assess Antiviral Activity of Argos's Arcelis™ Personalized Immunotherapy for Treatment of HIV Patients, AGS-004, Is Acceptable Strategy for At Least 16 Weeks
Date:5/3/2012

DURHAM, N.C., May 3, 2012 /PRNewswire/ -- Argos Therapeutics Inc. today announced that study results demonstrated that analytical treatment interruption to assess the antiviral activity of Argos's Arcelis™ personalized immunotherapy for the treatment of HIV patients, AGS-004, is an acceptable strategy for at least 16 weeks. Study results were published in the Journal of Medical Virology (84:885–889, 2012).

"Establishing the safety of analytical treatment interruptions of at least 16 weeks is an important step forward in assessing the impact of immunotherapy on viral load control," said Charles Nicolette, Ph.D., chief scientific officer and vice president of research and development of Argos. "Therapeutic vaccines such as AGS-004 have the potential to decrease long-term antiretroviral therapy which has limitations such as drug toxicity, the risk of developing resistance and others. We look forward to advancing our Phase 2b trial of AGS-004 to further demonstrate its efficacy and safety for the treatment of HIV patients."

The potential risks of short-term interruption of antiretroviral therapy in the AGS-004-001 study were assessed in a retrospective subgroup study analyzing data from patients in the strategies for management of anti-retroviral therapy (SMART) study with matched eligibility criteria. The subgroup analysis included 440 of 2,720 on the drug conservation (DC) arm and 436 of 2,752 on the viral suppression (VS) arm that matched the AGS-004-001 inclusion criteria and were used in the SMART subgroup analysis. In the first 16 weeks following randomization into the SMART study there were no deaths in either subgroup.  There were two AIDS-related events in the DC subgroup and one in the VS subgroup, making the overall risk of AIDS related events two per 100 person years (0.005%) and one per 100 person years (0.002%) in the two subgroups, respectively.  There were
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SOURCE Argos Therapeutics Inc.
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