Study indicates CYT107 expands CD4 T-Cells in gut mucosa of chronically HIV infected immunological non-responder patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today 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.

interleukin-7 'engages multiple mechanisms to overcome chronic viral infection'

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced publication of data showing that IL-7 is able to overcome many of the factors that thwart an effective immune response during chronic overwhelming viremia in diseases such as HIV infection and viral hepatitis. The results of this study also suggest how in the context of the reduced viral load established by current treatments for chronic viral diseases, IL-7 therapy could be used to produce and expand specific T-cells and promote a broad and durable immune mediated antiviral response.

Clinical case study on potential treatment for progressive multifocal leukoencephalopathy

Cytheris SA, a clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the publication of a case study report based on successful treatment of progressive multifocal leukoencephalopathy (PML) with combination therapy consisting of two investigational agents, Cytheris’ recombinant human interleukin-7 (CYT107) and CMX001, an investigational, oral broad-spectrum antiviral drug (Chimerix, Research Triangle Park, NC) in the Journal of Antimicrobial Chemotherapy. The combination therapy succeeded in eradicating the polyomavirus JC, the virus that causes PML, in less than two weeks following initiation of CYT107 treatment, and four weeks following the introduction of CMX001.

Progressive multifocal leukoencephalopathy (PML) is a rare and usually fatal neurological disease caused by the polyomavirus JC. The virus, first identified in 1971, multiplies in and destroys oligodendrocytes, which are cells of the brain that produce the myelin sheath surrounding neurons. Symptoms include loss of vision, impaired speech, paralysis, cognitive decline and weakness. There is no known cure for PML.

Study to investigate whether exhausting HIV reservoir and ultimately obtaining virus eradication is feasible

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of Phase II clinical trial of the company’s investigative immunomodulatory agent, CYT107 (rhIL-7), in combination with two potent antiretroviral drugs represented by the integrase inhibitor raltegravir (ISENTRESS - Merck & Co) and the CCR5 inhibitor, maraviroc (SELZENTRYTM - ViiV Healthcare).

The main hypothesis of this study is that by combining the most potent and synergistic 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.

Phase II clinical trial of recombinant human interleukin-7 (CYT107) in chronically infected HIV patients

Cytheris SA today announced that it has begun enrolling patients in INSPIRE 3, a Phase II clinical programme evaluating the effect of repeated cycles of the company’s investigative immune-modulator, recombinant human interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non-Responders (INR) after at least 24 months of highly active anti-retroviral therapy (HAART). The study will enroll a total of 80 patients at investigative sites in Italy, Switzerland and South Africa.

“We are pleased to announce that the INSPIRE 3 clinical program is underway. The repeated treatment cycles of CYT107 in this study mimic the way the product will be used in the clinical setting and should trigger an improved and more prolonged immune reconstitution, a stabilization of patient CD4+ T cell counts above 500/microlitre, and a decrease of the markers of activation/inflammation,” said Michel Morre, DVM, President and CEO of Cytheris. “The safety and efficacy results obtained in this trial will contribute to the clinical profile of CYT107 as a potentially important new option for HIV patients and will also serve to define the clinical end points in subsequent pivotal therapeutic studies.”