Argos Therapeutics' Arcelis Personalized Immunotherapy Platform in HIV Achieves Primary Endpoint in Phase 1 Trial

Argos Therapeutics' Arcelis Personalized Immunotherapy Platform in HIV Achieves Primary Endpoint in Phase 1 Trial

-Positive Immune Response Data Presented at XVII International AIDS Conference-

XVII International AIDS Conference
DURHAM, N.C.--(BUSINESS WIRE)--Argos Therapeutics today announced the presentation of positive immune response data from a Phase 1 clinical trial of AGS-004 in HIV-infected adults in combination with antiretroviral therapy (ART). AGS-004 achieved the trial's primary endpoint of induction of T cell response to patient-specific HIV antigens. AGS-004 is a personalized HIV immunotherapy generated by the Company's ArcelisTM technology. Arcelis is an immunotherapy platform for creating personalized, RNA-loaded dendritic cell-based therapies perfectly matched to each patient's unique virus. AGS-004 is currently undergoing a Phase 2a proof-of-concept trial. These data were presented in an oral poster discussion on August 5, 2008 at the XVII International AIDS Conference in Mexico City.

"The results from this study indicate that the Arcelis approach to personalized immunotherapy may overcome the hurdles faced by other HIV therapies, most significantly the genetic and antigenic variability of HIV," said Principal Investigator Jean-Pierre Routy, M.D., from McGill University Health Centre in Montreal. "By presenting a broad spectrum of autologous HIV antigens to T cells, this method induces a patient-specific immune response optimized for each patient. This unique profile, as well as the favorable safety data demonstrated in this trial, provides a strong foundation for a potentially successful treatment for HIV patients in the future."

John Bonfiglio, Ph.D., President and CEO of Argos, added that, "Argos is pleased and excited by these positive immune response data. In this trial, AGS-004 demonstrated important evidence of its ability to induce a patient-specific and potent immune response to HIV viral antigens. We believe that these data support our multi-center Phase 2a trial investigating the efficacy of AGS-004 in improving the immune system's ability to control viral replication in the absence of ART."

In April of this year, Argos reported positive safety and feasibility data from this Phase 1 trial. No serious adverse effects were reported after 12 months of follow-up, and the therapy was well tolerated. In addition, no spikes in viral load, significant changes in CD4 or CD8 cell counts, or manifestations of autoimmunity were observed during or after injections. Argos also successfully demonstrated manufacturing feasibility and production consistency of AGS-004.

The presentation, titled, "Autologous Dendritic Cell Immunotherapeutic (ArcelisTM for HIV): Tolerability and Immunogenicity in HIV-1 Infected Subjects Treated with ART," was authored by: J.P. Routy, Y. Yassien-Diab, C. Landry, D. Gagnon, O. Yegorov, M.R. Boulassel, Caroline Benoît-Hébert, R. Antar, I. Tcherepanova, D. Healey, R.G. Jain, L.H. Finke, C.A. Nicolette, and R.P. Sekaly.

About the AGS-004 Phase 1 Trial in HIV

Ten patients with HIV who achieved durable viral suppression with ART received AGS-004 in the Phase 1 trial. The primary study objective was to evaluate patient-specific anti-viral responses to the AGS-004 immunotherapeutic following four doses over four months. Secondary objectives were to evaluate 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 Pharma Company, Ltd. Argos' personalized immunotherapy program for HIV is funded in part by a contract with the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

About the ArcelisTM Technology

Arcelis is Argos' proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, other infectious diseases, and cancer. 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 their 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.