Cytheris' INSPIRE study data of HIV-infected patients with low CD4 T cell counts announced

Sep 15 2009

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced presentation of data from an interim analysis of CLI-107-06 (INSPIRE), a Phase I/IIa study of HIV-infected patients with low CD4 T cell counts. The patients were treated with a three-injection cycle of the Company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107). The analysis shows that CYT107 induces a dose dependent and sustained increase of CD4 T cells with many patients achieving CD4 counts > 500 cells/mm³. The INSPIRE data were presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held September 12-15, 2009, in San Francisco, CA (Abstract H-1230a).

“Even in the HAART era, it appears that low CD4 T cell counts place HIV infected persons at greater risk for a variety of serious morbidities. This study shows that treatment with IL-7 can increase CD4 T cell counts in many of these patients to levels that are within the “normal” range. We now need to know whether these increased CD4 T cell counts confer protection from these serious complications,” said Michael M. Lederman, MD, the Scott R. Inkley Professor of Medicine at Case Western Reserve University, Cleveland, Ohio, Associate Director, CWRU/UHC Center for AIDS Research, and Chairman of the INSPIRE study.

“The interim results with CYT107 closely mimic and even improve upon those seen in a recently published study in chronic HIV-infected patients treated with an earlier, non-glycosylated version (CYT 99 007) of Cytheris’ IL-7," said Yves Levy, MD, PHD, Scientific Director of the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) Vaccine Program, Service d'Immunologie Clinique, Hôpital Henri Mondor, Créteil, France and Inserm, Presenter, Principle Investigator and Co-Chair of the INSPIRE study. "These results show that 3 injections of IL-7 are sufficient to expand naive and memory T cells in the long term. Further studies are needed to demonstrate whether these biological effects translate into clinical benefits.”

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