|Argos AGS-004 Phase 2a trial in patients with HIV
Apr 23, 2011
Howdy Robert: I am Robert also. I just wanted to let you know that today March 29th at 11:28 AM EST I began a protocal program that you have on your bucket list. To make a short version you most likely are aware it is the ARGOS study with Dendrionic cell thearpy. If you have any thoughts or interests in my experience and progress of the study I am in I would be glad to keep you abreast. I have recently found your site and have been reading some of your articles. Thank you for sharing them with all of us. My partner is in the medical field as well and he was with me through these first injections today and actually every day by my side with positive reinforcement and incredible support since the first days I had the flu like symptoms of seroconversion. Well I said brief but I think this is brief for me. Should you have any interest let me know. Thanks, Robby
Response from Dr. Frascino
Hey there Robby,
Well I don't know if dendritic cell therapy is exactly on my bucket list, but I'm certainly a strong proponent of immune-based therapies as a critical piece for the cure of HIV/AIDS. Please feel free to send periodic updates. Below I'll post some additional informant about the ARGOS dendritic cell therapy protocol and the encouraging results reported at the recent medical conferences in Boston (CROI, February/March 2011) and Vienna (IAC, July 2010).
Good luck with the protocol Robby. I'm delighted you have a strong loving and committed partner to support and comfort you on this journey. Please know you have my support as well.
Positive outcomes from Argos AGS-004 Phase 2a trial in patients with HIV
The Phase 2a trial was a single-arm, open-label study of the safety, antiviral activity, and immunogenicity of AGS-004 in 22 HIV-infected patients in the U.S. Subjects received four doses of AGS-004 while on ART and then interrupted antiretroviral drug treatment while receiving study drug. Argos Therapeutics announced today that its Arcelis immunotherapy for the treatment of HIV, AGS-004, demonstrated positive outcomes with the primary endpoint of viral load control and a favorable safety and immunogenicity profile in a final analysis of a Phase 2a clinical trial. Data for AGS-004 were presented in a poster at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
In the study, AGS-004 was safe and well tolerated with no additional risks observed during structured treatment interruption (STI). Argos' personalized immunotherapy resulted in an unexpectedly long delay in viral rebound, time to peak viral load during STI and a markedly reduced viral load when compared to pre-antiretroviral therapy (ART) levels. A number of patients were able to continue the STI past 12 weeks, and they were able to generate CD8+ T cell proliferative responses to the individual antigens presented in AGS-004.
"The final analysis of the Phase 2a data reiterates our findings from the previously reported interim analysis that AGS-004 is well tolerated, immunogenic, potentially efficacious and safe," said Jean-Pierre Routy, M.D., principal investigator of the study at the McGill University Health Centre in Montreal. "Further testing will demonstrate that AGS-004 is a feasible treatment option for HIV-1 infected patients."
The Phase 2a trial, AGS-004-001, was a single-arm, open-label study of the safety, antiviral activity, and immunogenicity of AGS-004 in 22 HIV-infected patients in the U.S. Subjects received four doses of AGS-004 while on ART and then interrupted antiretroviral drug treatment while receiving study drug.
"AGS-004 is currently in a Phase 2b clinical trial that will further demonstrate the immunotherapy's efficacy and safety in the treatment of HIV patients," said Jeff Abbey, president and chief executive officer of Argos. "The Phase 2b study is expected to enroll a total of 42 patients in nine sites in the U.S. and Canada, and it is funded by the National Institutes of Health as part of a $32 million contract that Argos was awarded in 2006. We are also planning to initiate a Phase 3 clinical trial with our Arcelis immunotherapy in renal cell carcinoma, AGS-003, in mid-2011."
The Phase 2a study's primary endpoint was to assess the ability of AGS-004 to improve immune control of HIV-1 replication, as measured by the proportion of subjects with HIV-1 RNA levels of <1000 copies/mL on at least three time points after STI. Secondary endpoints included the immunologic activity as measured by CD8+ T cell responses to AGS-004 therapy and HIV-1 RNA set point established after STI versus pre-ART plasma HIV-1 RNA set point.
The Medical News
Argos's dendritic cell therapy reduces HIV during treatment interruption (25/07/2010)
A dendritic cell therapy by Argos Therapeutics, called AGS-004, was able to keep virus at least partially under control during a 12-week antiretroviral treatment interruption. A dendritic cell therapy by Argos Therapeutics, called AGS-004, was able to keep virus at least partially under control during a 12-week antiretroviral (ARV) treatment interruption, according to a study presented Monday, July 19, at the International AIDS Conference (IAC), being held July 18 to 23 in Vienna.
AGS-004 treatment involves a three-step process. First, researchers collect a person's dendritic cellsan immune cell that presents fragments of viruses or bacteria to CD4 cells. The researchers then load the dendritic cells with HIV messenger RNA derived from the specific strains of HIV that a person carries. Lastly, the dendritic cells are reintroduced by infusion. The scientific poster presented at IAC by Jean-Pierre Routy, MD, from the McGill University Health Center in Montreal, and his colleagues included data on additional patients from the AGS-004-001 study, which has been reported on before.
AGS-004-001 is a Phase IIa study designed to determine the safety and signs of efficacy of AGS-004 during a 12-week interruption of ARV treatment in 38 people with HIV. People with fully suppressed HIV for at least six months while on ARV therapy and a CD4 count above 450 were eligible to participate in the study.
During the study, participants received four monthly infusions of AGS-004 along with ARV therapy and then two further infusions during a 12-week treatment interruption. Virus levels during the treatment interruption were compared with a participant's viral load before he or she started ARV therapy. Currently, 29 people have received AGS-004, and 18 have completed a full 12-week treatment interruption.
Routy reported that 15 of the 18 participants had reductions in virus from pre-ARV treatment levels, with an average drop of 1.29 logs. At the end of the 12-week treatment interruption, eight people had a viral load of less than 10,000 copies, and 6 had a viral load less than 5,000 copies. Three people failed to respond to the treatment, two because their CD4 count dropped below 350 during the treatment interruption. Side effects to therapy included injection site reactions, flu-like symptoms and gastrointestinal symptoms, with no AIDS-related complications emerging during the study.
"AGS-004 was safe, well tolerated and resulted in an unexpectedly long delay in viral rebound, time to peak viral load during a structured treatment interruption, and a markedly reduced viral load when compared to [pre-ARV treatment] levels," Routy's team concluded.
Argos hopes to begin a Phase IIb study this year to further explore AGS-004 treatment.
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