Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Preparing compound containing saccharide radical
Reexamination Certificate
1999-11-19
2003-11-04
Salimi, Ali R. (Department: 1645)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Preparing compound containing saccharide radical
C435S091330, C435S320100, C536S023720
Reexamination Certificate
active
06642032
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
FIELD OF THE INVENTION
The present invention relates generally to recombinant avian interferon polypeptides and genetic sequences encoding same, and uses therefor. In particular, the present invention is directed to the use of recombinant avian IFN-&ggr; polypeptides as an immune response modulator and as a growth enhancing agent in avian species. The present invention is particularly useful in the prophylactic and therapeutic treatment of birds against coccidiosis and the causative agent thereof.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The rapidly increasing sophistication of recombinant DNA technology is greatly facilitating research into the medical and veterinary fields. Cytokine research is of particular importance, especially as these molecules regulate the proliferation, differentiation and function of a great variety of cells, such as cells involved in mediating an immune response. Administration of recombinant cytokines or regulating cytokine function and/or synthesis is becoming, increasingly, the focus of medical research into the treatment of a range of disease conditions in humans and animals. The present invention seeks to provide novel reagents and methods that employ recombinant cytokine polypeptides, for the treatment of disease conditions in birds.
2. Description of Related Art Including Information Disclosed Under 37 C.F.R. 1.97 and 1.98
In mammals, interferons (IFN) represent a family of cytokines that share the capacity to inhibit viral replication and to exert effects on immune function. There are two distinct types of IFN. Type I IFN is produced by a variety of cell types in response to viral infection and includes IFN-&agr; and -&bgr;. Typically, IFN-&agr; is produced by leukocytes such as monocytes and macrophages while fibroblasts and epithelial cells are the major source of IFN-&bgr;. Type I IFNs share a high degree of amino acid homology, bind to the same cell surface receptor and there biological functions are resistant to heat and low pH treatment. (Weissmann and Weber, 1986).
In contrast, the production of IFN-&ggr; in mammals is restricted to activated T cells and NK cells and is encoded by a gene that is unrelated to those which express IFN-&agr; or IFN-&bgr;. Features that distinguish IFN-&ggr; from -&agr;/&bgr; include their binding to different cell surface receptors and that the former is exquisitely sensitive to heat and low pH treatment (Weissmann and Weber, 1986). Another distinction is the ability of IFN-&ggr;, but not IFN-&agr; or IFN-&bgr;, to stimulate macrophages to produce reactive nitrogen intermediates such as nitric oxide, nitrate and nitrite (Fast et al, 1993; Huang et al, 1993).
Chicken T cells produce IFN following stimulation with antigen or mitogen (Prowse and Pallister, 1989; Lowenthal et al, 1993; Pusztai et al, 1986; Weiler and von Bulow, 1987; Dijkmans et al, 1990) as measured by the ability to protect chick embryonic fibroblasts (CEF) from virus-mediated lysis. There has been controversy as to whether this IFN activity is the Type I interferon, or alternatively, an avian equivalent of mammalian IFN-&ggr; (Lillehoj et al, 1992).
The gene for chicken Type I IFN (ChIFN-&agr;) has recently been cloned (Sekellick et al, 1994) and when the protein was compared to mammalian IFNs it was shown to have 20-24% amino acid sequence identity to Type I IFNs, whereas it was unrelated to known mammalian IFN-&ggr; polypeptides. Furthermore, recombinant ChIFN-&agr; was shown to have antiviral activity, but lacked macrophage activating function in that it was unable to induce nitrite secretion in monocytes (Schultz et al, 1995), consistent with the properties of mammalian Type I IFN.
U.S. Ser. No. 08/765,381, which is incorporated herein by way of reference, teaches genetic sequences encoding avian IFN-&ggr; from chicken reticuloendotheliosis virus (REV)-transformed spleen cell cultures (Lowenthal et al, 1995 a, b). That specification further teaches the isolation of homologous IFN-&ggr;-encoding genetic sequences from species other than chickens, gene constructs and viral vectors comprising said genetic sequences, methods for the production of recombinant avian IFN-&ggr; using the said gene constructs and viral vectors, and methods of prophylaxis and treatment using the recombinant polypeptides. The avian and mammalian IFN-&ggr; polypeptides are only 30% identical, as determined using the ClustalW programme and the algorithm of Thompson et al., 1994), or alternatively, 32% identical as determined using the ClustalV programme.
Birds suffer from a variety of diseases that represent a considerable cost to the poultry industry, including diseases that are produced by bacteria and viruses, such as, for example, infectious bronchitis virus, avian infectious laryngeotracheitis virus, infectious bronchitis virus, Newcastle disease virus, Marek's Disease virus, chicken anemia virus, avian influenza virus,
E. coli,
Salmonella ssp., Eimeria ssp. and Mycoplasma ssp., amongst others.
For example, the causative agent of coccidiosis in birds, Eimeria ssp., in particular
E. acervulina,
is capable of infecting birds at any period in their life cycle. Coccidiosis represents a considerable cost in terms of reduced productivity, because the disease in birds prevents digestion for about 4-5 days, thereby leading to a considerable weight loss, costing the industry approximately $700 million per annum. Current treatments for coccidiosis include the use of chemicals in feed stocks.
SUMMARY OF THE INVENTION
This application is a continuation-in-part application of U.S. Ser. No. 08/765,381, the entire contents of which are incorporated herein by way of reference.
Bibliographic details of the publications referred to in this specification by author are collected at the end of the description.
Sequence Identity Numbers (SEQ ID NOs.) for the nucleotide and amino acid sequences referred to in the specification appear after the claims.
Throughout this specification and the claims that follow, unless the context requires otherwise, the word “comprise”, or variations such as “comprises” or “comprising” will be understood to imply the inclusion of a stated element or integer or group of elements or integers, but not the exclusion of any other element or integer or group of elements or integers.
Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications. the invention also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations or any two or more of said steps or features.
In work leading up to the present invention, the inventors sought to produce improved methods for the prophylactic and therapeutic treatment of a wide range of diseases in birds, and, in particular, the prophylactic and therapeutic treatment of coccidiosis.
The inventors cloned avian IFN-&ggr; cDNAs and genes and produced recombinant gene constructs comprising same for the expression of recombinant IFN-&ggr; polypeptides therefrom, as described in U.S. Ser. No. 08/765,381 which is incorporated herein by way of reference.
Immunoreactive molecules, in particular polyclonal and monoclonal antibodies have been produced to the recombinant avian IFN-&ggr; polypeptide of the invention.
Additionally, the inventors have discovered that avian IFN-&ggr; administered to birds is capable of promoting the growth of birds, as well as preventing weight loss associated with pathogenic infections when administered thereto as a prophylactic or therapeutic reagent by any means. The present invention clearly encompasses the use of avian IFN-&ggr; as an immunomodulatory molecule both in homologous species and across species boundaries.
Accordingly, one aspect of the present invention provides a method of treatment or pr
Johnson Michael A.
Lowenthal John W.
O'Neil Terri E.
York Jennifer J.
Commonwealth Scientific and Industrial Research Organisation
Greenlee Winner and Sullivan P.C.
Salimi Ali R.
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