Argos Therapeutics Presents Positive Phase 2 Viral Load and Immune Response Data for Arcelis[TM] HIV Program at the AIDS Vaccine 2009 Conference.Personalized Immunotherapy Candidate Demonstrates: * Viral Load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. Control in Absence of Antiretroviral Therapy * Robust Immune Response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. to a Diverse Set of 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. Antigens * Potential to Offer Independence from Antiretroviral Therapy DURHAM, N.C. and PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- Argos Therapeutics today announced two presentations at the AIDS Vaccine AIDS vaccine A hypothetical vaccine intended to either prevent HIV infection or ensure that those infected will not fall victim to AIDS; the most promising vaccine is that using a naked DNA plasmid, reported by Letwin et al in 20/10/00 Science; as of early 2001, 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the Company's Arcelis[TM] technology, and is a personalized, RNA-loaded, dendritic dendritic /den·drit·ic/ (den-drit´ik) 1. branched like a tree. 2. pertaining to or possessing dendrites. den·drit·ic adj. Relating to the dendrites of nerve cells. cell-based immunotherapy that is perfectly matched to each patient's unique HIV viral burden. The presentations contained important results, including a favorable safety profile for AGS-004, the ability to induce partial to complete viral load control in the absence of antiretroviral therapy (ART) during a 12-week structured treatment interruption (STI STI systolic time intervals. ), and a potent and diverse immune response to AGS-004 treatment. These AGS-004 results are unprecedented for an immunotherapeutic candidate in HIV and, if confirmed in an upcoming randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. study, could lead to a new treatment paradigm for HIV. "The Arcelis approach to immunotherapy has broad potential as a new therapeutic strategy to combat HIV," said Jean-Pierre Routy, M.D., from McGill University Health Centre The McGill University Health Centre (MUHC) (in French, Centre universitaire de santé McGill) is a network of five teaching hospitals in Montreal, Quebec, Canada, all of which are affiliated with McGill University. in Montreal. "The level of viral load control in response to AGS-004 has been unexpectedly strong compared to what has been reported for other immunotherapies tested in similar patient populations. Additionally, because this approach uses patient-specific HIV antigens, it may overcome the extreme genetic heterogeneity of HIV from patient to patient, which has been one of the reasons for the failure of prior HIV immunotherapies." In an oral presentation, Dr. Routy, principal investigator of the ongoing Phase 2a trial, discussed data assessing the safety and impact of AGS-004 in controlling viral load during a 12-week STI from ART. Patients enrolled in the trial had pre-ART viral load levels ranging between 10,000-500,000 copies/mL. Data were presented for 16 patients that had successfully completed the STI. After the three month treatment break from ART, 13 of 16 patients had a lower viral load compared to their pre-ART levels, with a mean reduction of greater than 1 Log, corresponding to a greater than 80% reduction from pre-ART levels. AGS-004 also exhibited a favorable side-effect and safety profile, with no reports of autoimmunity or AIDS-defining events during the STI, and no treatment-related serious adverse events reported. Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics, commented, "These data demonstrate that AGS-004 may make a significant impact on pre-ART viral load levels during an STI, and that it is potentially able to keep patients safely off of ART for at least three months. Most of the patients in this trial were chronically infected, and did not have a genetic predisposition genetic predisposition Molecular medicine The tendency to suffer from certain genetic diseases–eg, Huntington's disease, or inherit certain skills–eg, musical talent to viral control. Therefore, the large reduction in viral load from pre-ART is a very promising outcome. These data provide strong support for one of the main therapeutic objectives of AGS-004, that it could potentially offer patients partial or complete independence from ART, thereby addressing the side effects Side effects Effects of a proposed project on other parts of the firm. , resistance, and compliance issues associated with ART and improving patients' quality of life." In a poster session, Bader Yassine-Diab, Ph.D., from the National Immunomonitoring Laboratory (NIML NIML Not in My Lifetime NIML Never in My Life NIML Non-Indigenous Minority Language ) at the University of Montreal Research Center, presented additional data supporting patients' immune response to the autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. HIV antigens used in AGS-004 - Gag, Nef, Rev, and Vpr - following STI. Researchers analyzed patients' anti-HIV-specific immune responses by evaluating the proliferation and the functionality of CD8+ and CD4+ T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. stimulated with these autologous HIV antigens. Preliminary results indicated an increase in HIV-specific CD8+ T-lymphocyte polyfunctional populations following immunotherapy with AGS-004, which was accentuated after the STI from ART. "Although still preliminary, we are impressed with the diversity and strength of the immune responses observed so far. Importantly, the immune responses were composed of the same types of T cells observed in long-term non-progressors, which are individuals who are infected with HIV, but whose infection does not rapidly progress to AIDS," said Rafick Sekaly, Ph.D., Scientific Director of the NIML. Based on these positive data from the current Phase 2a study, Argos is planning on initiating a Phase 2b trial in the first half of 2010. The majority of the costs of this next trial will be funded by the National Institutes of Health, as part of a $21 million contract that Argos was awarded in 2006. The first abstract, titled, "Safety and Viral Load Changes in HIV-1 Infected Subjects Treated with Autologous Dendritic Immune Therapy Following ART Discontinuation," was authored by J.P. Routy, M.R. Boulassel, M.R. Loutty, S. Vezina, C. Tremblay, J. Angel, J. Gill, J. Baril, F. Smaill, R. Jain, D. Healey, I. Tcherepanova, C. Nicolette, and R. Sekaly. The second abstract, titled, "Immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. of an Autologous Dendritic Cell dendritic cell n. 1. A cell that has branching processes. 2. Any of the cells in the neural crest of the embryonic ectoderm having extensive processes and developing early as producers of melanin. Anti-HIV Therapy in HIV-1 Infected Individuals," was authored by B. Yassine-Diab, Z. Coutsinos, C. Landry, D. Gagnon, D. Sauve, C. Hebert-Benoit, V. Hebert, M.R. Boulassel, J.P. Routy, R. Jain, I. Tcherepanova, D. Healey, C. Nicolette, and R. Sekaly. This work was funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS , under Contract No. N01-AI-60019. About the Arcelis[TM] 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. The development of Arcelis is part of Argos' broad collaboration with Kyowa Hakko Kirin Co., Ltd. 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. www.argostherapeutics.com |
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