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Cytheris Announces Notice of Allowance for U.S. Patent Covering the Preparation and Uses of Its Glycosylated Recombinant Human Interleukin-7 (CYT107)

Tuesday, February 02, 2010

New Patent Extends Protection to 2026

Paris, France -- Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "Glycosylated IL-7, Preparation and Uses", US Patent Application Number 11/996,176. The Notice of Allowance is the USPTO’s official communication that the Company’s application has successfully completed examination and that a patent will be issued.

"We are pleased to announce receipt of this Notice of Allowance by the USPTO," said Michel Morre, DVM, President and CEO of Cytheris. "This patent, together with our recently issued patent covering IL-7 pharmaceutical composition, provides broad protection for Cytheris’ recombinant human interleukin-7 (CYT107), a critical immune-modulator for immune T-cell recovery and enhancement, and extends this protection in the U.S. to 2026."

Together these two patents protect an IL-7 composition for therapeutic use containing the purified protein as a drug substance with the correct disulfide bridging, the appropriate glycosylation profile and polypeptidic purity. This latest patent also protects various hyperglycosylated analogs and various fusion proteins.

Considerable evidence from basic immunology, preclinical models and, more recently, from clinical studies, confirms the unique role of IL-7 in the functioning of the immune system and especially in providing the right cells in sufficient numbers and functional properties to support and improve specific immune responses against infectious agents and malignant cells. In that light, as with EPO for red blood cells and G-CSF for neutrophils, IL-7 plays a pivotal role in supporting T cell expansion and function.

IL-7 was originally discovered by Immunex Corporation (now part of Amgen) and through a process of intellectual property acquisition resulting from several mergers, the compound eventually ended up at what is today Sanofi-Aventis, from whom Cytheris holds the exclusive worldwide license. Cytheris also holds the rights to an additional IL-7 patent family acquired under an exclusive worldwide license from the Washington Research Foundation of the University of Washington, Seattle.

As the exclusive licensee, Cytheris holds all original patents protecting IL-7 and various uses including the use for T cell expansion and for enhancing humoral and cellular immunity.

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 thymopoïesis and, downstream from the thymus, on homeostatic expansion of peripheral T-cells.

A first-generation form of rhIL-7 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 rhIL-7 product made by Cytheris via a recombinant mammalian cell culture system.

Clinical trials conducted on more than 120 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 HIV, HBV, HCV, idiopathic CD4 lymphocytopenia (sponsored by NIAID/NIH) and cancer, the latter including an NCI/NIH-sponsored study of IL-7 in combination with dendritic cell vaccines in a pilot study of tumor vaccination in children, and a study designed to restore CD4+ and CD8+ counts following T-cell depletion due to bone marrow or peripheral blood stem cell transplant (being conducted at the Memorial Sloan-Kettering Cancer Center in New York City).

About Cytheris –

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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