Argos Therapeutics Initiates Phase 2 Proof-of-Concept Trial for its Arcelis™ Personalized Immunotherapy Platform in HIV
DURHAM, N.C. – May 12, 2008 – Argos Therapeutics today announced the initiation of a Phase 2a proof-of-concept clinical trial to test the efficacy of its AGS-004 therapy in improving immune control of viral replication in HIV-infected adults. AGS-004 is a product of the Company's Arcelis™ technology, a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient's unique HIV viral burden. The target population for the study is HIV-1 infected patients with durable viral suppression from active antiretroviral therapy (ART).
"New HIV treatments, such as AGS-004, that could complement ART, provide a break or reduce the duration of ART, or even replace ART in some cases, would be a welcome addition to the available treatments for HIV," said Lothar Finke, M.D., Chief Medical Officer of Argos. "Although treatment with ART raises T-cell counts and improves patient immune function, its use does not improve the immune system's ability to control HIV replication, which we believe AGS-004 is able to do."
"The initiation of this proof-of-concept trial demonstrates our continued progress in the development of breakthrough immunotherapy-based treatments," said John Bonfiglio, Ph.D., President and CEO of Argos. "We believe that our personalized approach may overcome the lack of specific immune response to a broad range of HIV antigens seen with other HIV immunotherapies to date. Argos' Arcelis technology platform loads autologous dendritic cells with patient-specific antigens from whole viral RNA, which induces extensive, potent immune targeting of distinct variants of the HIV virus in each patient."
In April, Argos reported positive safety and feasibility data from the Phase 1 trial of AGS-004 in HIV-infected adults on ART. The Company plans to present full Phase 1 trial results, including immune response data, at the International AIDS Conference in August 2008.
About the AGS-004 Phase 2a Trial in HIV
Approximately 34 subjects with HIV who are currently receiving ART will be enrolled in the Phase 2a trial. The study will be conducted at up to 15 sites in North America. The primary study objective is to assess the efficacy of AGS-004 therapy in improving immune control of HIV-1 replication. Secondary objectives include evaluating the safety and tolerability of AGS-004, exploring its immunologic activity, and investigating the mechanism of action for AGS-004. This study is supported by the Canadian Institute of Health Research, Canadian Clinical Trials Network and the National Institutes of Health (USA). The development of AGS-004 is part of Argos' broad collaboration with Kirin Pharma Company, Ltd.
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.