Business Wire - September 09, 2009

PARIS - Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that data from an interim analysis of its INSPIRE Phase I/IIa study of HIV-infected patients with low CD4 T cell counts treated with a three injection cycle of the Company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107), will be presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to be held September 12-15, 2009, in San Francisco, CA.

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, H|pital Henri Mondor, Creteil, France and Inserm, Principle Investigator and Co-Chair of the INSPIRE study will present the interim data analysis from the clinical trial.

The presentation details are as follows:

Session: 143-HIV, Monday, September 14, 2009, 8:30 AM -11:00 AM

Session Type: Slide Session

Location: Room 301

Abstract Number: H-1230a

Presentation Time: Monday, September 14, 2009, 10:15 AM -10:30 AM

Presentation Title: Effects of r-hIL-7 on T Cell Recovery and Thymic Output in HIV-infected Patients Receiving Antiretroviral Therapy. Interim Analysis of a Phase I/IIa Multicenter Study

Authors: Y. LEVY(1), I. SERETI (2), G. TAMBUSSI (3), J. ROUTY (4), J. DELFRAISSY (5), J. MOLINA (6), M. A. FISCHL (7), T. CROUGHS (8), R. SEKALY (9), M. LEDERMAN (10); (1)Hosp. H. Mondor, Creteil, France, (2)NIAID/NIH, Bethesda, MD, (3)San Raffaele Scientific Inst., Milano, Italy, (4)MUHC, Montreal, Canada, (5)Hosp K. Bic tre, Kremlin Bic tre, France, (6)Hosp St Louis, Paris, France, (7)Univ. of Miami Sch. of Medecine, Miami, FL, (8)Cytheris, Issy-Les-Moulineaux, France, (9)NIML, Montreal, Canada, (10)Case Western Reserve Univ., Cleveland, OH.

About Interleukin-7 (CYT107)

Recombinant human interleukin-7 (CYT107) is a critical immune-modulator for immune T-cell recovery and enhancement. As a growth factor and cytokine physiologically produced by marrow or thymic stromal cells and other epithelia, IL-7 has a critical and, at some steps, a non-redundant stimulating effect on T lymphocyte development, notably on thymopoiesis and, downstream from the thymus, on homeostatic expansion of peripheral T-cells. A first-generation non-glycosylated form of rhIL-7 (CYT 99 007) was shown in pre-clinical and Phase I studies in oncology and HIV-infected patients to be well tolerated in repeated dose trials, with long-lasting increases in both CD4 and CD8 T cells. CYT107 is a second-generation glycosylated rhIL-7 product made by Cytheris via a recombinant mammalian cell culture system. Clinical trials conducted on more than 110 patients in Europe, North America and Taiwan have demonstrated the potential of IL-7 to expand and protect CD4 and CD8 T-cells. Currently, Cytheris is conducting multiple international investigations of IL-7 in HCV, HIV and cancer, with trials for other indications planned to initiate in 2H09.

About Cytheris û www.cytheris.com

Cytheris SA is a privately held clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation. These drugs aim at reconstituting and enhancing the immune system of patients suffering from cancer, chronic viral or bacterial infections such as HCV, HBV and HIV, or lympho-depleting treatments such as chemotherapy, radiotherapy, bone marrow transplantation (BMT) and hematopoietic cell transplantation (HCT). The company operates from its headquarters and laboratories in Issy-les-Moulineaux, a suburb of Paris, and its U.S. subsidiary in Rockville, Maryland.

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