Cytheris Announces Results of Phase IIa Study Indicating that Recombinant Interleukin-7 Expands CD4 T-Cells in HIV-1 Infected Patients
News Mar 04, 2011
Cytheris SA, has announced results of a multi-center Phase IIa study designed to investigate the potential of Interleukin-7 (CYT107) therapy to reconstitute CD4 T-cells in chronically HIV-1 infected patients whose CD4 T-cell counts remained low despite treatment with anti-retroviral-therapies (HAART).
In addition to providing further evidence of the ability of IL-7 to stimulate the expansion of CD4 and CD8 T-cells in peripheral blood, the results demonstrate the importance of IL-7 in stimulating T-cell repopulation of the lymphoid tissue layer in the mucous membrane of the GI tract. This effect, previously demonstrated in SIV infected monkeys, is now confirmed by analysis of rectosigmoid biopsies in this study of HIV infected patients defined as Immunological Non-Responders (INR).
The analysis of these mucosal gut biopsies shows a 3.93-fold increase in CD4 T-cell counts following IL-7 treatment. The data were presented at the 2011 Conference on Retroviruses and Opportunistic Infections (CROI) held in Boston, February 27–March 2.
The results of the Phase IIa study (Abstract #H-113: Recombinant Interleukin-7 (CYT107) Expands CD4 T-cells in Peripheral Blood and Gut Mucosa of Chronically HIV-Infected Immunological Non-Responder Patients, Irini Sereti, Jean-Pierre Routy, Margaret Fischl, Thérèse Croughs, Stéphanie Beq, Michel Morre, M R Boulassel, Michael Yao, William Thompson, and Michael M. Lederman) were presented by Irini Sereti, M.D., M.H.S., NIAID/NIH Study Investigator and INSPIRE 2 Study Co-Chair.
“CD4 T-cell depletion in gut mucosa is an early and key pathogenic event in HIV infection that is associated with T-cell activation,” said Michel Morre, DVM, president and CEO of Cytheris. “Despite successful anti-retroviral therapy (HAART), significant morbidity and mortality persists in HIV infection, particularly in patients who fail to restore normal CD4 T-cell counts. The results of the current study suggest that IL-7, which targets expansion of the T-cell pool in both peripheral blood and mucosal sites, may be able to play a pivotal role in immune restoration in chronic HIV infection.”
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