Personalized Immunotherapy Clinical Trial Initiated in HIV Patients with Argos Therapeutics' AGS-004.DURHAM, N.C. -- Argos Therapeutics today 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 Noun 1. highly active antiretroviral therapy - a combination of protease inhibitors taken with reverse transcriptase inhibitors; used in treating AIDS and HIV drug cocktail, HAART (HAART HAART highly active antiretroviral therapy. HAART Highly active antiretroviral therapy, triple combination therapy AIDS The concurrent administration of 2 nucleoside reverse transcriptase inhibitors–eg, AZT and 3TC, and a protease ). 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. 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 For other places with the same name, see Royal Victoria Hospital (disambiguation). The Royal Victoria Hospital at 687 Pine Avenue West in Montreal, Quebec, Canada was established in 1893, through the financial contributions of two Scottish immigrants, Donald Smith and George , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Argos. "With two other clinical trials ongoing in metastatic renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. and B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. , 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 Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , NC. The Company has clinical trial programs in cancer and human immunodeficiency virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV) and has an ongoing co-development and commercialization alliance with the Pharmaceutical Division of Kirin Brewery Company Kirin Brewery Company, Ltd. (麒麟麦酒株式会社 , Limited. |
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