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clinical trials
current trials


Current Trials

Validated Technology
Argos’ Arcelis personalized RNA-loaded dendritic cell immunotherapy technology platform has been validated in human clinical trials in kidney cancer and HIV. In the initial clinical trials in kidney cancer, the immunotherapy was well tolerated, induced a potent anti-tumor response and demonstrated encouraging clinical responses. In the initial HIV clinical trial, the immunotherapy was also well tolerated and the primary endpoint of induction of T cell response to patient-specific HIV antigens was achieved. See publication section.

Therapeutic Areas
Metastatic Renal Cell Carcinoma (RCC)
Argos has completed two phase 2 clinical trials of its Arcelis™ immunotherapy, AGS-003, as both a single-agent and in combination with sunitinib in patients with newly diagnosed, metastatic RCC. Encouraging clinical and immunologic responses have been observed in these trials. In addition, the combination of AGS-003 plus sunitinib has been associated with a median overall survival longer than reported for sunitinib alone in unfavorable risk, metastatic RCC. These trials have also demonstrated that AGS-003 continues to be well tolerated (no serious adverse events attributed to AGS-003) and confirmed the commercial feasibility of producing the product at a central manufacturing facility, with delivery to multiple clinical trial sites throughout North America.

Argos launched the ADAPT Phase 3 clinical trial for AGS-003 in January 2013. The trial is expected to enroll 450 patients in approximately 120 sites, mostly in North America.   To be considered for the ADAPT study patients must be 18 or older, newly diagnosed with clear cell mRCC and identified at diagnosis as unfavorable risk with 1-4 baseline risk factors, based on the recently validated Heng risk factor model. Patients must also be candidates for standard tumor removal surgery and treatment with standard targeted drug therapy, starting with sunitinib. For more information about AGS-003 and the ADAPT study, visit www.ADAPTkidneycancer.com.

See publication section for further details

Human Immunodeficiency Virus (HIV)
Argos is currently conducting a randomized, double-blind, placebo-controlled Phase 2b trial of its Arcelis immunotherapy targeted to HIV. This trial is measuring the safety and efficacy, in terms of viral load control, of the therapy. Argos recently completed treating HIV patients in a multicenter Phase 2a trial. Interim results from this Phase 2a trial, presented at the 2010 International AIDS conference, demonstrated that the candidate AGS-004 achieved a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment (ART) interruption when compared to pre-ART viral loads. The novel Argos RNA-loaded DC therapy for HIV utilizes small plasma samples from infected patients to amplify large quantities of viral RNA encoding selected antigens, resulting in a personalized treatment to the patient’s own strain of virus. For further information see the following site at http://www.clinicaltrials.gov/ct2/show/NCT01069809?term=ARgos+and+HIV&rank;=3

Systemic Lupus Erythematosus (SLE)
Argos has an anti-Interferon-alpha monoclonal antibody, AGS-009, that is being tested in a phase 1 clinical trial in SLE patients.


Description Indication Status
AGS-003 Metastatic Renal Cell Carcinoma Ph 3 ready www.adaptkidneycancer.com
AGS-004 HIV Ph 2
AGS-009 Lupus Ph 1