Argos Therapeutics' Arcelis HIV Immunotherapy Demonstrates Significant Reduction in Viral Load and Delay in Viral Rebound Kinetics in Interim Analysis of Phase 2 Study

Data for Personalized Dendritic Cell-Based Immunotherapy Presented in Two Posters and an Oral Presentation at the International AIDS Conference

VIENNA, AUSTRIA | July 19, 2010 | Argos Therapeutics today announced that, in an interim analysis of a Phase 2 trial, its Arcelis immunotherapy targeted at HIV, AGS-004, demonstrated a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment interruption (ARTI) when compared to pre-ART viral loads. The data will be presented in an oral poster presentation session. ART represents a major breakthrough for the management of HIV-infected patients, but is not without side effects and is a life-long commitment. Therapeutic immunotherapies to enhance immune response and control viral replication are needed to limit exposure to ART.

Data from an analysis of 22 patients who have completed the 12 weeks ARTI in the ongoing, multicenter Phase 2 trial were presented by Jean-Pierre Routy, M.D., principal investigator of the study at the McGill University Health Centre in Montreal, at the International AIDS Conference (AIDS 2010) in Vienna, Austria. The mean reduction in viral load at week 12 of the ARTI for responders (n=14) compared to the pre-ART sample was 1.30 log. The mean time to detectable viral rebound during the ARTI was delayed compared to previous studies (2 weeks vs 3.77 weeks) and the median time to peak viral load during the ARTI was also delayed (8 weeks). Patients were able to remain safely off ART for a median time of 17.2 weeks and an average of 25.1 weeks. Importantly, the patients who completed the 12 week ARTI did not exhibit a significant decline in CD4 cell counts. The treatment was well tolerated with no significant adverse events related to AGS-004 reported.

In a second poster presentation, Charles A. Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development for Argos, presented an analysis of immune responses induced by AGS-004 and their relationship to viral load control. The immune monitoring data demonstrated a correlation between the induction of effector memory CD8+ T cells and viral load control and underscored the importance of avoiding activation of CD4+ T cells, a unique property of AGS-004.

"The updated results from this study demonstrate that AGS-004 is well tolerated, immunogenic, potentially efficacious and safe," said Dr. Routy. "We are encouraged that the upcoming, double-blind, placebo controlled, randomized Phase 2b study co-funded by the NIH may further show that this personalized immunotherapy is feasible for the treatment of HIV-1 infected patients."

Jeffrey Abbey, President and Chief Executive Officer of Argos, added, "Our unique and broadly applicable approach to personalized immunotherapy has demonstrated the ability to produce measurable immune responses against HIV and forms of cancer, including renal cell carcinoma as demonstrated by recently presented data from a Phase 2 study of AGS-003. Coupled with the automation of our manufacturing process, we believe that our Arcelis platform can yield promising treatments for patients that can be complimentary adjuncts to current drug therapy."

About the Arcelis™ Technology

Arcelis is Argos' proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, cancer and other infectious diseases. This platform is based on optimizing a patient's own (autologous) dendritic cells to trigger a pathogen- or tumor-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 customized to the patient's specific disease.

About Argos Therapeutics, Inc.

Argos is an immunotherapy company developing new treatments for cancer, infectious and autoimmune diseases and transplantation rejection. The Company has generated multiple platform technologies and a diverse pipeline of products based on its expertise in the biology of dendritic cells — the master switch that turns the immune system on or off.

SOURCE: Argos Therapeutics

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