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news.Cytheris has initiated the Phase II clinical trial (EraMune 01) of its investigative immunomodulatory agent, CYT107 (rhIL-7), in combination with two antiretroviral drugs represented by the integrase inhibitor raltegravir (Isentress - Merck & Co) and the CCR5 inhibitor, maraviroc (Selzentry - ViiV Healthcare).
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EraMune 01 is designed and sponsored by the French not-for-profit institution Objectif Recherche VACcin Sida (ORVACS) with financial support from the Bettencourt-Schueller Foundation, Paris, France.
EraMune 01 main hypothesis is that by combining the antiretroviral drugs, coupled with an immunomodulating agent capable of targeting or inducing activation of latently infected cells, the reservoirs of HIV can be decreased and, in the best case scenario, eradication of the virus may be feasible.
Cytheris said that EraMune 01, an nternational, multicenter, randomised, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV-infected patients with long-term viral suppression, is a further investigation of the company’s investigative immunotherapy, CYT107 (recombinant human interleukin-7, or IL-7), already the subject of seven other studies for different indications.
Principal investigator of the study Christine Katlama said first, the use of antiretroviral therapy combining drugs with different HIV enzyme targets or receptors and different penetrations in cells, to suppress the virus to truly undetectable levels; secondly, the addition of an immunomodulatory therapy that specifically targets viral reservoirs; and lastly, the selection of patients already having a low HIV reservoir as measured by peripheral blood HIV DNA content.
Cytheris chief medical officer Therese Croughs said that IL-7 in combination with conventional antiretroviral therapy has demonstrated in early clinical studies that it promotes restoration of T cell numbers and function and induces some HIV replication in the CD4+ T cell subset, including quiescent T cells, while also expanding the pool of uninfected CD4+ T cells.
"The hypothesis tested in this study is that with a new antiretroviral therapy combination complemented by entry and integrase inhibitors, the induction of viral replication from quiescent CD4+ T cells can be contained by the complementary HIV inhibitors while remaining sufficient to expose infected cells to immune elimination, eventually contributing to viral reservoir reduction and potential eradication," Croughs said.