RNA-loaded dendritic cell-based immunotherapy new trials in Carolinas

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Personalized immunotherapy clinical trial initiated in HIV patients with Argos Therapeutics’ AGS-004
02-09-2007

DURHAM, N.C. -- Argos Therapeutics announced the initiation of a Phase 1/2 clinical trial to test the immunologic activity and safety of its AGS-004 in HIV-infected adults. The target population for the study is patients with durable viral suppression from highly active antiretroviral therapy (HAART). AGS-004 is a personalized RNA-loaded dendritic cell-based immunotherapy that is designed to stimulate the patient’s immune system to target and destroy the patient’s own unique viral burden.

“Non-personalized HIV immunotherapies are unable to raise cytotoxic T lymphocytes against HIV antigens, fail to induce T cell memory, and, most importantly, do not provide antiviral protection against the patient’s own particular virus,” said Jean-Pierre Routy, M.D., of McGill University Health Center and Royal Victoria Hospital, the principle investigator and sponsor of the study. “A personalized immunotherapy addresses these issues because it is able to capture private viral mutations, providing a matched, complete immune response for each individual HIV patient. This approach may overcome the weaknesses of other available therapies and therefore could result in a better chance of success for HIV treatment.”

“We believe that this important milestone demonstrates Argos’ leadership in the development of RNA-loaded dendritic cell-based immunotherapies,” said John N. Bonfiglio, Ph.D., President and CEO of Argos. “With two other clinical trials ongoing in metastatic renal cell carcinoma and B-cell chronic lymphocytic leukemia, our next-generation technology is applicable to a broad array of indications and may present a potentially paradigm-shifting treatment method for infectious diseases and cancer.”

About the AGS-004 Phase 1/2 Trial in HIV
Ten patients with HIV who are on HAART will be enrolled in the Phase 1/2 trial. The primary study objective is to evaluate patient-specific anti-viral response to the AGS-004 immunotherapeutic following four doses over four weeks. Secondary trial objectives are to evaluate its 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 Brewery’s Pharmaceutical Division.

RNA-loaded Dendritic Cell Technology
Argos’ proprietary approach to personalized HIV immunotherapy is based on optimizing a patient’s own (autologous) dendritic cells to trigger a 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 their disease. Through this process, dendritic cells are enabled to recognize the complete antigenic repertoire of a particular patient’s disease, resulting in an immunotherapy personalized for a patient-specific response.

About Argos Therapeutics, Inc.
Argos Therapeutics is developing breakthrough immunotherapies that target the unique features of a patient’s disease. This new generation of personalized cancer and infectious disease therapeutics trains the immune system to recognize and attack the disease. Argos’ scientific leadership in RNA-loaded dendritic cells and advanced manufacturing processes provide a platform to tackle virtually all forms of cancers and infectious diseases. www.argostherapeutics.com

Argos is a private biotechnology company headquartered in Research Triangle Park, NC. The Company has clinical trial programs in cancer and human immunodeficiency virus (HIV) and has an ongoing co-development and commercialization alliance with the Pharmaceutical Division of Kirin Brewery Company, Limited.

CONTACT:
MacDougall Biomedical Communications, Chris Erdman, 508-647-0209
Argos Therapeutics, Jeff Abbey, 919-287-6308