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NIH Funds Study of Fully Personalized Immunotherapy AGS-004 Combined With a Latency Reversing Therapy for the Treatment of HIV
 
 
  NIH Division of AIDS Approves $6.6 Million to Fund Investigator-Initiated Phase 2a Adult Eradication Study
 
DURHAM, N.C., April 1, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS) ("Argos"), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced that the NIH Division of AIDS (DAIDS) has approved $6.6 million in funding for an investigator-initiated Phase 2a adult eradication study of AGS-004, the company's investigational fully personalized immunotherapy for HIV.
 
Eliminating the latent virus reservoir has been shown to be an essential goal in efforts to eradicate HIV. Research has shown that histone deacetylase (HDAC) inhibitors can activate cells that are latently infected with HIV, making them more visible to the immune system. One strategy to achieve HIV eradication is known as the "kick and kill" approach where a latency reversing therapy such as an HDAC inhibitor is combined with an immunotherapy to maximize the immune system's response to the latent reservoir in an effort to eliminate it. "Previous study results suggest AGS-004 can induce anti-viral memory T-cell responses that are associated with lower persistent viral reservoirs when administered in combination with standard antiretroviral therapy (ART)," said Dr. Charles Nicolette, Argos' chief scientific officer and vice president of research and development. "The continued support of DAIDS allows us to move forward with stage two of our adult eradication trial, which has already been cleared for initiation by the FDA. We believe that this is the first human clinical trial to test the highly promising 'kick and kill' approach to treatment."
 
"With this NIH funding, we can now study whether combining AGS-004 treatment with a latent reservoir mobilizer can lead to the elimination of HIV-infected cells," stated Dr. David Margolis of the University of North Carolina, principal investigator of the AGS-004 Phase 2a adult eradication study. "In stage two of this study, patients on ART will receive the HDAC inhibitor vorinostat in addition to AGS-004."......[In a recent trial testing the therapy, called AGS-004, Argos did not meet the primary endpoint.......despite not reaching the primary endpoint, the trial showed that 70 percent of patients who received the therapy, called AGS-004, had specific positive antiviral responses. None of the patients in the placebo group showed this response....see below bottom of this report]
 
Media contact:
 
Adam Daley
Berry & Company Public Relations
212-253-8881
 
Investor contact:
 
Nancy Yu
Burns McClellan
 
212-213-0006
 
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http://www.sec.gov/Archives/edgar/data/1105533/000117184315000170/newsrelease.htm
 
Argos Therapeutics Provides Update on Clinical Research for Investigational Fully Personalized Immunotherapy for the Treatment of HIV
Findings from Phase 2b trial support clinical development of AGS-004 in adult eradication and pediatric studies.
 
DURHAM, N.C., Jan. 9, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today provided an update on its clinical research program for AGS-004, the company's investigational fully personalized immunotherapy for the treatment of HIV. The companyannounced top-line results of its double-blind, placebo-controlled Phase 2b clinical trial of AGS-004 in patients chronically infected with HIV-1. The primary endpoint of the trial, which required a 1.1 Log lower median viral load (VL) after 12 weeks of interruption of antiretroviral therapy (ATI) in the treatment group versus the placebo group, was not achieved. Importantly, however, data from the trial provided evidence of the ability of AGS-004 to induce memory T-cell responses which may have directly impacted the latent viral reservoir. Of the patients who received AGS-004 and completed ATI, approximately 70 percent had positive antiviral memory T-cell responses prior to ATI versus zero percent of placebo patients. Also, within the AGS-004 treatment group, those patients that had antiviral memory T-cell responses had significantly fewer CD4+ T-cells with integrated HIV DNA when compared to non-responders. These findings relate directly to the utilization of AGS-004 in an ongoing adult eradication study and a planned pediatric study, where one of the key objectives is todecrease the latent HIV reservoir. The ongoing adult eradication study is expected to enter stage two in the coming months, and the pediatric study is planned to initiate this year.
 
In the Phase 2b trial, 54 patients received four doses of AGS-004 or placebo every four weeks while on standard antiretroviral therapy (ART), and then began a 12-week ATI, during which dosing continued every four weeks. In total, 36 participants completed ATI, 23 of whom received AGS-004. The trial was fully funded by NIAID, NIH (No. NO1-A1-60019).
 
"By demonstrating that AGS-004 induced memory T-cell responses in a majority of patients and that those immune responders had fewer CD4+ T-cells with integrated HIV DNA, these data suggest that induced anti-viral memory T-cell responses may contribute to lower persistent viral reservoirs," said Dr. Charles Nicolette, chief scientific officer and vice president of R&D of Argos. "These data support our plans to continue testing AGS-004 in the studies aimed at decreasing or eliminating the latent HIV reservoir. In addition, based on these data we believe that more frequent dosing of AGS-004 during ART may provide further benefit, but also highlight the need to better understand the mechanisms of immune evasion employed by the HIV virus in the absence ofART."
 
"The results of the AGS-004 Phase 2b trial allow us to now ask if combining AGS-004 treatment with HDAC inhibitors, part of a new class of latent reservoir mobilizers, will lead to the elimination of HIV-infected cells," stated Dr. David Margolis of the University of North Carolina, principal investigator of the AGS-004 Phase 2a adult eradication study. "We look forward to initiating stage two of the adult eradication study where patients on ART will receive the HDAC inhibitor vorinostat in addition to AGS-004."
 
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). The Company is also developing a second Arcelis®-based product candidate, AGS-004, for the treatment of HIV, currently being evaluated in a phase 2 clinical trial in combination with a latency reversing drug for HIV eradication in adult patients. For more information about Argos Therapeutics, visit
 
www.argostherapeutics.com.
 
 
 
 
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