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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
-Study Results Published in Journal of Medical Virology-
Durham, NC- May 3, 2012 — 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 6/440 subjects (1.4%) in the DC subgroup and 4/436 subjects (0.92%) in the VS subgroup who experienced grade 2 adverse events defined as AIDS-related event, a cardiovascular disease, renal or hepatic event, cancer or death.
About the Arcelis™ Technology
Arcelis is Argos´s proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies. This platform is based on optimizing a patient´s own (autologous) dendritic cells to trigger a tumor- or pathogen-specific immune response. To address the challenge of the unique genetic profile of each patient´s disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA (“mRNA”) isolated from the patient´s disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is fully personalized for each patient´s disease.
About Argos Therapeutics, Inc.
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on its Arcelis™ technology platform. Using biological components from each patient, Arcelis-based immunotherapies employ the patient´s dendritic cells to activate an immune response specific to the patient´s disease. Argos´ most advanced product candidates include AGS-003 for the treatment of metastatic renal cell carcinoma, or mRCC, and AGS-004 for the treatment of HIV.
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