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Cytheris expands Interleukin-7 clinical development program with phase I/IIa trial in HIV


Paris, September 26, 2007 - Cytheris, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced expansion of the clinical trial program for CYT107, the company's recombinant human Interleukin-7 (IL-7), with the initiation of a Phase I/IIa clinical trial in HIV patients. The trial will be conducted at sites in France, Italy, Canada and the United States and follows the launch of previously announced Phase I/IIa trials of IL-7 in Hepatitis C (HCV) and oncology. These trials also follow the successful completion of four Phase I studies and are designed to investigate IL-7's potential for building immune system response.

The announcement was made at the mini-symposium entitled 'Interleukin-7 in Health and Disease' in the series 'Frontiers in Medicine' at the Nobel Forum, Karolinska Institutet, held in Stockholm, Sweden, September 17-18, 2007.

The Forum brought together twelve invited speakers before an international audience to review and exchange results on IL-7 biology, cell functions, receptors and key preclinical and clinical results. Cytheris President and CEO, Michel Morre, DVM, announced the start of the Phase I/IIa trial in HIV and presented promising preclinical and clinical results obtained in cancer and HIV. Morre's presentation was part of the section devoted to IL-7 clinical development chaired by Markus Maeurer, Professor of Clinical Immunology at the Karolinska Institutet.

Forum participants expressed particular interest in pursuing various avenues of IL-7 investigation including: 1) Oncology, in association with chemo- and immunotherapy; 2) HIV infection, to reconstitute the immune system and trigger an anti-viral response, potentially limiting the incidence of AIDS-related and non-related pathologies; 3) HCV infection, to speed viral clearance and increase the proportion of patients able to clear the virus; and, 4) various other chronic infections such as tuberculosis.

'We are happy to see the Nobel Foundation hold the first international meeting exclusively dedicated to IL-7,' said Morre. 'The exchanges between top international experts confirm the therapeutic potential of this cytokine in the treatment of immune compromised patients suffering from lymphopenia as well as cancer and chronic viral infections. Progressively, a large set of results derived from cell biology, preclinical and now clinical studies demonstrates the therapeutic potential of IL-7. Our new Phase I/IIa studies in HIV, oncology and HCV are designed to further document these effects.'

About the HIV Study

The HIV trial (CYT107-06) is a randomized placebo controlled, single-blind multi-center dose-escalation study of chronically HIV-infected patients with CD4 T-lymphocyte counts between 101-400 cells/mm3 and plasma HIV RNA < 50 copies/mL after at least 12 months of Highly Active Anti-Retroviral Therapy (HAART). The trial will be conducted at sites in the US, Canada, France and Italy.

Michael M. Lederman, MD, the Scott R. Inkley Professor of Medicine and Director of the Case Western Reserve University/University Hospitals Center for AIDS Research, Cleveland, Ohio, will chair the study along with co-chairs Irini Sereti, MD, US National Institute for Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, and Yves Levy, MD, PhD, Service d'Immunologie Clinique, Hôpital Henri Mondor, Créteil, France.

Results of two promising Phase I studies of Cytheris' IL-7 in HIV patients, one conducted by Dr. Levy's team and the other by the US National Institutes of Health/AIDS Clinical Trials Group (ACTG), were reported at the 2007 Conference on Retroviruses and Opportunistic Infections (CROI) held in Los Angeles.

About the Oncology Study

The oncology trial (CYT107-04) targets patients with metastatic melanoma or advanced renal cell carcinoma. This dose escalation study, to include 18 to 30 patients both lymphopenic and non-ly


Publisher Contact Information:

Andrew Lloyd & Associates
+44 1273 675100
allo@ala.com

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