четверг, 3 марта 2011 г.
Enthusiastic outcomes from Argos AGS-004 Phase 2a trial run in patients with HIV
Argos Therapeutics announced today that its Arcelis immunotherapy for the benefit of the treatment of HIV, AGS-004, demonstrated certain outcomes with the primary endpoint of viral weight hold back and a favorable sanctuary and immunogenicity side-view in a final inquiry of a Phase 2a clinical trial. Text representing AGS-004 were presented in a announcement at the 18th Symposium on Retroviruses and Opportunistic Infections (CROI) in Boston.
In the ruminate on, AGS-004 was secure and well tolerated with no additional risks observed during structured treatment surcease (STI). Argos' individualized immunotherapy resulted in an unexpectedly extended dilly-dally in viral rebound, time to perfection viral encumbrance during STI and a markedly reduced viral overwhelm when compared to pre-antiretroviral treatment (ART) levels. A calculate of patients were masterful buying revatio online to continue the STI sinc e 12 weeks, and they were skilful to father CD8+ T room proliferative responses to the individualistic antigens presented in AGS-004.
The conclusive analysis of the End 2a matter reiterates our findings from the hitherto reported interim study that AGS-004 is grandly tolerated, immunogenic, potentially efficacious and unpolluted, said Jean-Pierre Routy, M.D., diva investigator of the chew over at the McGill University Fitness Nucleus in Montreal. Urge onwards testing wish march that AGS-004 is a doable treatment alternative for HIV-1 infected patients.
The Viewpoint 2a check, AGS-004-001, was a single-arm, open-label think over of the aegis, 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 ARTISTRY and then interrupted antiretroviral analgesic treatment while receiving consider drug.
AGS-004 is currently in a Angle 2b clinical trial that see fit extra evidence the immunotherapy's efficacy and safety in the treatment of HIV patients, said Jeff Abbey, president and chief manager officer of Argos. The Configuration 2b weigh is expected to enroll a total number of 42 patients in nine sites in the U.S. and Canada, and it is funded not later than the Jingoistic Institutes of Fitness as component of a $32 million contract that Argos was awarded in 2006. We are also planning to drill a Facet 3 clinical try with our Arcelis immunotherapy in renal apartment carcinoma, AGS-003, in mid-2011.
The Phase 2a survey's germinal endpoint was to assess the gifts of AGS-004 to look up immune control of HIV-1 replication, as cautious not later than the suitableness of subjects with HIV-1 RNA levels of 1000 copies/mL on at least three convenience life points after STI. Derivative endpoints included the immunologic occupation as cautious about CD8+ T stall responses to AGS-004 treatment and HIV-1 RNA set feature established after STI versus pre-ART pl asma HIV-1 RNA freeze point.
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