Findings from Phase 2b trial support clinical development of AGS-004 in adult eradication and pediatric studies.
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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 to decrease 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.
"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.
Conference Call and Webcast Information
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About the Arcelis® Technology Platform
Arcelis® is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient's disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small tumor or blood sample and the patient's own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.
Forward Looking Statements
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about Argos and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund our continuing operations for the period anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis and receive approval from the
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