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Argos Therapeutics’ Arcelis(TM) Personalized Immunotherapy Platform in HIV Achieves Primary Endpoint in Phase 1 Trial

2008-08-05 07:30:00

Argos Therapeutics’ Arcelis(TM) Personalized Immunotherapy Platform in HIV Achieves Primary Endpoint in Phase 1 Trial

-Positive Immune Response Data Presented at XVII International AIDS


DURHAM, N.C.–(EMWNews)–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 trials primary endpoint of

induction of T cell response to patient-specific HIV antigens. AGS-004

is a personalized HIV immunotherapy generated by the Companys

Arcelis technology. Arcelis is an

immunotherapy platform for creating personalized, RNA-loaded dendritic

cell-based therapies perfectly matched to each patients

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 systems

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 (Arcelis

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 Arcelis 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

patients own (autologous) dendritic cells to

trigger a pathogen- or tumor-specific immune response. To address the

challenge of the unique genetic profile of each patients

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 patients

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.

MacDougall Biomedical Communications
Jennifer Greenleaf,

Argos Therapeutics
Jeff Abbey,


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