MXPA02002742A - Glucosamine and egg reducing inflammation - Google Patents

Abstract

The invention is directed to a composition and method for the treatment and prevention of inflammation and inflammatory related disorders. The composition is glucosamine in combination with an egg product. It is generally preferred that the egg product is obtained from an avian which has been hyperimmunized with an immunogenic mixture and or which contains an anti inflammatory composition.

Description

GLUCOSAMINE AND EGG TO REDUCE INFLAMMATION BACKGROUND OF THE INVENTION Field of the Invention The invention relates to a method for reducing inflammation in animals. More particularly, the invention relates to the combination of the egg product and glucosamine to produce a synergistic effect to reduce inflammation, and particularly arthritis, in animals.

Inflammation Inflammation, as defined in the Dorland Medical Dictionary, is "a localized protective response, produced by the damage or destruction of tissues, which serves to destroy, dilute or sting the noxious agent and the damaged tissue." It is characterized by the fenestration of the microvasculature, filtration of the elements of the blood in the interstitial spaces, and the migration of leukocytes in the inflamed tissue. On a macroscopic level, this is usually accompanied by the signs REF. 136645 clinical signs of erythema, edema, hyperalgesia (sensitivity), and pain. During this complex response, chemical mediators such as histamine, 5-hydroxytryptamine, various chemotactic compositions, bradykinin, leukotrienes, and prostaglandins are locally released. Phagocytic cells migrate within the area, and cellular lysosomal membranes can be broken, releasing lytic enzymes. All these events can contribute to the inflammatory response. In the particular case of rheumatoid arthritis, the resulting inflammation similarly involves the combination of an antigen with a complement antibody which causes the local release of chemotactic and chemoactivating compositions that attract leukocytes. The leukocytes phagocytose the antigen-antibody and complement complexes, and also release the many enzymes contained in their lysosomes. These lysosomal enzymes then cause damage to the cartilage and other tissues, and this is in addition to the degree of inflammation. Immune reactions mediated by cells may also be involved. Prostaglandins, which are key intracellular regulators of cellular function, are also released during this process.

The inflammatory response is any response characterized by inflammation as defined above. It is well known, by those experts in medical techniques, that the inflammatory response causes much of the physical discomfort (ie, pain, and loss of function) that has become associated with different diseases and injuries. Arthritis Arthritis manifests itself in a variety of ways. Some of the most common forms include rheumatoid arthritis, osteoarthritis and generalized rheumatism. Rheumatoid arthritis is an autoimmune disease characterized by pain, swelling and stiffness in the joints. Rheumatoid arthritis is a disease that afflicts approximately 3% of Americans, and particularly women. Rheumatoid arthritis is an extremely disabling disease and usually strikes adults between the ages of 30 and 40 years, while the occurrence of clinical disease is greater among those aged 40 to 60 years. Although drug therapy is somewhat effective, as many as 7% of those who suffer from rheumatoid arthritis are disabled to a degree as quickly as 5 years after the start of treatment. illness, and within 10 years, as many as 50% are unable to work. Osteoarthritis produces symptoms similar to rheumatoid arthritis. In particular, although osteoarthritis begins as a particular cartilage degeneration while rheumatoid arthritis begins as inflammation in the synovium, each process approaches the other as soon as the disease progresses. In osteoarthritis, as soon as the cartilage deteriorates and the congruence of the joint is altered, reactive synovitis often develops. Conversely, as soon as rheumatoid arthritis erodes the cartilage, secondary osteoarthritis changes the bone and develops in the cartilage. In the final stages of both osteoarthritis and rheumatoid arthritis, the joints involved appear to be the same. Some other forms of arthritis include ankylosing seronegative spondyloarthropathy (ankylosing spondylitis) and reactive arthritis. These conditions are often referred to as the "associated diseases B-27" and are difficult to differentiate from rheumatoid arthritis. In some cases ankylosing spondylitis, Reiter's syndrome or psoriatic arthritis are coincidentally present with Arthritis rheumatoid in the same patient. In many cases, these patients are treated with the same drugs that modify the disease as those suffering from progressive rheumatoid arthritis. The onset of arthritis usually occurs after the age of 30 in those who are susceptible to such disease. However, some forms of arthritis can be initiated by different causes, such as slow virus infections. Since they overlap a lot, many doctors consider these forms as "generalized rheumatism" and roughly handle diseases in the same way. Some diseases which fall into this category include Chronic Fatigue Syndrome, fibromyalgia (fibrositis) and gout. In fact, for some patients, evidence accumulates by superimposition of rheumatoid arthritis and fibromyalgia. Autoimmune diseases As stated above, rheumatoid arthritis is an autoimmune disease, and as such, its etiology is very similar to the etiology of any other autoimmune disease. The body usually recognizes the difference between its own byproducts, and foreign invaders. (ie, bacteria, viruses, fungi and protozoa, to say a few). When an immune cell (T or B lymphocyte) reacts to the "autoprotein" during its development, that cell is considered defective and usually destroyed or inactivated. Sometimes, however, a "self-reactive" immune cell will escape destruction. At a certain late time, that cell can be activated and triggers an immune response. The activation is thought to occur after infection with a common bacterium or virus which contains a polypeptide that has an extension of amino acids which couple an extension in the defective autoprotein. Several bacteria, such as Streptococcus, Mycoplasma, and borrelia, have been implicated in the onset of the disease, as well as certain viruses, ie retroviruses. In addition to rheumatoid arthritis, autoimmunity often results in such diseases as juvenile diabetes, multiple sclerosis, Graves' disease, Meneri's disease, myasthenia gravis, lupus erythematosus, and psoriasis. (Medical Sciences Bulletin, September 1994). Autoimmunity affects specific organs. For example, some autoimmune diseases of the bile ducts of the liver, and kidneys "'are: primary biliary cirrhosis, necrotising glomerulonephritis, idiopathic crescentic glomerulonephritis, liver and kidney disease. induced by viruses, chronic hepatitis, drug-induced and autoimmune hepatitis (Gershwin, Manns and Mackay 1992). Immune destruction of the Langerhans islets results in diabetes mellitus (Hagopian and Lernmark 1992) and insulin autoantibodies have been described (Palmer 1987). There is a large category of systemic vasculitis diseases in which autoimmune mechanisms have been suggested as the cause of pathogenesis. Some of the diseases are: leukocytoclastic angitis, polyarteritis nodosa, Goodpasture's syndrome, Kawasaki's disease, Wegener's granulomatosis, Churg-Struass syndrome, giant cell arteritis, Takayasu's arteritis, lupus mediated by the immune complex, rheumatoid vasculitis, and Cryoglobulinemic, Henoch Sclonlein purpura (Kallenberg, 1996; Jennette, Jones, Falk, 1992). There is also a body of evidence that autoimmunity can play a role in many forms of heart disease which include: postpericardiotomy syndromes and post-myocardial infarction, myocarditis and idiopathic dilated cardiomyopathy. Autoimmunity may be responsible for the progression of acute disease from cardiac to degenerative muscle. (Rose, Neumann, Burek, Herskowitz 1992).

Symptomatic involvement of skeletal muscle is common in many autoimmune diseases such as polymyositis or inflammatory myopathy (which may include rheumatoid arthritis)., polymyalgia rheumatica, myasthenia gravis, myasthenic myopathy, neurogenic atrophy, motor neuron disease, fibromyalgia, fibrositis, muscular dystrophy, endocrine, metabolic and carcinomatous myopathy). (Hollingsworth, Dawkins, Thomas 1992). Other diseases with autoimmune origins can be uveitis, Vogt-Koyanagi-Harada syndrome (Detrick and Hooks 1992), and Sjögren's syndrome, scleroderma, ankylosing spondylitis, dermatomyositis, psoriasis, psoriatic arthritis, Reiter's syndrome (NIH 1994). Evidence of autoantibodies has also been found in Alzheimer's disease (Singh et al., 1992), dementia complex (Mastroianni et al., 1991) and autistic children (Singh et al., 1993). Several neurological diseases such as Sydenham's chorea, chronic obsessive compulsive disorders (OCD), attention deficit hyperactivity disorder (ADHD), Tourette's syndrome (TS) and some cases of schizophrenia may have an autoimmune component and can they be associated ??? Antineuronal antibodies (Medical Sciences Bulletin, September 1994). This summary is not all inclusive and those in the art are familiar with other autoimmune diseases, such as, for example, Guillain-Barré syndrome (idiopathic polyneuritis). Treatment In order to treat inflammatory related disorders, it is a common medical practice to administer pharmacological agents that reduce the physical discomfort of the inflammatory response. Agents that have these properties are classified as anti-inflammatory. Anti-inflammatory drugs are used to treat a broad spectrum of disorders, and the same drugs are often used to treat different diseases. The treatment with. Anti-inflammatory drugs is not for the disease, but most often for the symptoms (ie, inflammation). The anti-inflammatory, analgesic and antipyretic drugs are a heterogeneous group of compounds, often not chemically related, which nevertheless share certain therapeutic actions and side effects. Corticosteroids represent the most commonly used class of compounds for the treatment of inflammation. Proteolytic enzymes represent another class of compounds that are thought to have anti-inflammatory effects. Hormones that directly or indirectly cause the adrenal cortex to produce and secrete steroids represent another class of anti-inflammatory compounds. Unfortunately, natural and synthetic corticosteroid preparations cause a number of severe side effects, which include elevated blood pressure, salt and water retention, increased kidney and potassium damage, and calcium excretion. On the other hand, corticosteroids can mask the signs of infection and increase the spread of infectious microorganisms. These hormones are considered unsafe for use in pregnant women, and long-term corticosteroid therapy has been associated with gastric hyperactivity and / or peptic ulcers. Treatment with corticosteroids can also aggravate diabetes mellitus, which requires high doses of insulin, and can produce psychotic disorders. Hormonal antiinflammatory agents which indirectly increase the production of endogenous corticosteroids have the same potential for adverse side effects.

Another common treatment for inflammation, and in particular rheumatoid arthritis, other arthritis and other autoimmune diseases, is drug therapy. In general, patients are initially treated with "first line" agents, usually non-steroidal anti-inflammatory drugs (NSAIDs), which mainly improve symptoms. Patients are ultimately treated with disease modifying agents (DMARDs) and second-line drugs such as methotrexate, gold compounds, penicillamine, sulfasalazine, and antimalarial drugs, however, all of the above drugs have serious side effects, especially when are administered in high doses, for example, aspirin, an NSAID, can cause indigestion and stomach pain, phenylbutazone can cause stomach ulcers and phenacetin can lead to kidney disease, methotrexate can cause oral ulceration and gastrointestinal side effects (GI). If a natural food product having anti-inflammatory effects can be obtained, it can provide an easily administrable, readily available, and safe therapeutic composition for the treatment of arthritis, autoimmune diseases and inflammation in general.

Passive immunization Several genera of the class Birds, such as chickens (Gallus domesticus), turkeys and ducks, produce antibodies in the blood and eggs against immunogens that cause diseases in birds, as well as against other immunogens. For example, LeBacq-Verheyden et al. (Immunology 27: 683 (1974)) and Leslie, G.A. , et al. (J. Med. 130: 1337 (1969)), have quantitatively analyzed chicken immunoglobulins. Polson, A., et al. (Immunological Communications 9: 495-514 (19080)) immunized hens against several proteins and natural protein mixtures,. and detected IgY antibodies in egg yolks. Fertel, R., et al. (Biochemical and Biophysical Research Communications 102: 1028-1033 (1981)) immunized hens against prostaglandins and detected antibodies in the egg yolk. Jensenius et al. (Journal of Immunological Methods 46: 63-68 (1981)) provides a method for isolating egg yolk IgG for use in immunodiagnostics. Polson et al. (Immunological Communications 9: 475-493 (1980)) describes antibodies isolated from the egg yolk of hens that are immunized with a variety of plant viruses. U.S. Patent No. 4,357,272 describes the isolation of antibodies from the egg yolks derived from hyperimmunized chickens. Hyperimmunization occurs by repeated injections of immunogens derived from plant viruses, human IgG, tetanus antitoxin, viper antivenoms, and Serameba. U.S. Patent No. 4,550,019 discloses the isolation of egg yolks from antibodies raised in the hen by hyperimmunization with immunogens having a molecular or particle weight of at least 30,000. The immunogens used to hyperimmunize chickens are they select from among several plant viruses, human immunoglobulins, tetanus toxin, and viper venoms. U.S. Patent No. 4,748,018 describes a method of passive immunization of a mammal comprising parentally administering purified antibody obtained from the eggs of a bird that has been immunized against the corresponding antigen, and wherein the mammal has acquired immunity for the eggs. U.S. Patent No. 5,772,999, assigned to DCV-Biologics, describes a method for preventing, counteracting or reducing chronic gastrointestinal disorders or gastrointestinal damage induced by nonsteroidal anti-inflammatory drugs (induced by NSAIDs) in a subject for administering hyperimmunized egg and / or milk or fractions thereof to the subject. U.S. Patent Application Serial No. 09 / 233,379 describes the existence of an anti-inflammatory factor found in the egg of a hyperimmunized bird. An immunized egg is an egg which comes from a bird which has been immunized with, for example, a specific antigen or mixture of antigens. A hyperimmunized egg is an egg which comes from a bird which has been brought to a specific state of immunization by means of, for example, periodic administrations of reinforcement of antigens. Hyperimmunized eggs, regardless of the type of antigen administered by the poultry producer, have been found to have several beneficial factors, which include, as mentioned above, the treatment of chronic gastrointestinal disorders, gastrointestinal damage induced by NSAIDs (see US Application No. 08 / 688,576) and anti-inflammatory effects due to the presence of an anti-inflammatory composition (see, for example, US Application No. 09 / 233,379).

Glucosamine Glucosamine is an agent ... chondroprotector which has been studied for its potential beneficial effects in osteoarthritis. Chondroprotective agents are those which, in addition to "improving symptoms, appear to help balance the synthesis and degradation of cartilage tissue." Glucosamine has been known by biologists for several decades as an endogenous aminomonosaccharide synthesized from glucose Its importance in joint dysfunctions is related to its physiological role in the synthesis of proteoglycans and glycosaminoglycans, which are components of cartilage.The research in the past four decades suggests that glucosamine is effective in reducing the symptoms of dysfunction of joints and is well tolerated Glucosamine significantly reduces pain and sensitivity and improves mobility Researchers have proposed several mechanisms of putative glucosamine benefits in joint health.In vitro studies have suggested that glucosamine affects the cartilage metabolism, one such It is effects can be the stimulation of proteoglycan synthesis, as observed with SAMe. Another possibility is that glucosamine increases the expression of chondrocyte genes. In addition, glucosamine can act as an anti-inflammatory agent, although the effect is 50 to 300 times less than NSAID. However, NSAID exerts its anti-inflammatory effects by inhibiting the cyclooxygenase enzyme system and therefore interferes with prostaglandins, while glucosamine does not. The anti-inflammatory effect may be the result of stimulating the synthesis of proteoglycans, which can stabilize cell membranes. A recent in vitro study shows that the adhesion of chondrocytes increased by glucosamine effectively reverses the abnormal reduction in adhesion which occurs in the degeneration of joints. SUMMARY OF THE INVENTION The invention is based on the inventors' discovery that there is an anti-inflammatory activity when combining an egg and egg products, and in particular, an egg or hyperimmune egg products, with glucosamine and administering them to a animal object in such a way that administration results in reduction, and sometimes even avoids inflammation and inflammatory related disorders in that target animal.

In particular, the invention is directed to a composition which comprises glucosamine and an egg product. The invention is also directed to a method for reducing inflammation in a subject, the method comprising administering to the subject an effective amount of glucosamine and an egg product. The invention is further directed to a method for reducing serum fibrinogen levels. The method comprises administering to a subject an effective amount of glucosamine and an egg product. The invention further comprises a method for reducing or preventing the onset of rheumatoid arthritis, the method comprising administering to the subject an effective amount of glucosamine and an egg product. The invention finally covers a method for reducing or preventing the onset of osteoarthritis, the method comprising administering to the subject an effective amount of glucosamine and an egg product. BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a bar graph depicting the effect of the hyperimmune egg and glucosamine in the rat adjuvant arthritis model.

Figure 2 is a bar graph which represents the levels of plasma fibrinogen in the rat adjuvant arthritis model. DESCRIPTION OF THE INVENTION The invention relates to the discovery that the combination of the egg product with glucosamine works synergistically against inflammation and inflammation-related disorders. The following definitions apply throughout the application: Definitions The term "inflammation" is used in its recognized sense in the art as a localized protective response produced by tissue damage or destruction which serves to destroy, dilute or wall the harmful agent and the noxious tissue, characterized in the inappropriate, uncontrolled way, by the classical sequence of pain, heat, redness, swelling, and loss of function, and histologically involves a complex series of events, which include the dilation of arterioles, capillaries, and venules with increased permeability and blood flow, exudation of fluids which include plasma proteins, and migration of leukocytes in the inflammatory focus.

The term "arthritis" means any variety of disorders marked by inflammation and 'degeneration of connective tissue structures, especially joints and related structures. It can be treated for pain, stiffness or limited movement of these parts. Some forms of arthritis include rheumatoid arthritis, osteoarthritis, ankylosing seronegative spondyloarthropathy, reactive arthritis, chronic fatigue syndrome, fibromyalgia (fibrositis) and gout. The term "autoimmune disease" is applied to the standard medical definition as "found in standard medical dictionaries such as Dorland and Taber." A description of a variety of autoimmune diseases can be found in the background section of this document. term "hyperimmunization" means exposure to one or more antigens in such a way that an immune response rises and maintains above the natural unexposed state.The terms "egg" or "egg product" each means any whole egg (proposed, hyperimmunized or another form) or any product or fraction derived from it.

The terms "proposed egg" or "proposed egg product" each means an entire egg, or any product or fraction derived therefrom, obtained from egg-producing animals which are not maintained in a hyperimmune state. The terms "hyperimmune egg" or "hyperimmune egg product" each means whole egg or any product or fraction derived therefrom, obtained from an animal that produces egg maintained in a hyperimmune state, and which contains the anti-inflammatory composition. as described by US Serial Number 09 / 233,379. The term "supranormal levels" means levels in excess of those found in eggs of egg producing animals not maintained in a hyperimmune state. The term "anti-inflammatory composition" means the composition described in United States Serial Number 09/233, 379 and in the present, which counteracts or suppresses the inflammatory process. The term "partially pure egg anti-inflammatory composition" means an anti-inflammatory composition described as such in United States Serial Number 09 / 233,379.

The term "combinatorial derived immunogens" refers to a process for generating the molecule diversity among the immunogens by the combinatorial synthesis form. The term "biomodified immunogens" refers to immunogens which are obtained through the process of gene cloning and genetic manipulation technologies which allow the insertion and translation of proteins which have antigenic properties. The term "genetic vaccine" refers to the nucleic acid vaccine which is generally produced by recombinant technologies and which produce an immune response. The term "treatment" means that the onset of symptoms (which include pain) of the disorder and / or the pathogenic origin of the disorder are delayed or completely avoided, or, if present, symptoms are improved or eliminated completely. For example, the glucosamine plus hyperimmune egg product treats arthritis and / or an autoimmune disease not only by suppressing the symptoms of the disorder in humans and other mammals, but also by acting as an agent prophylactic to counteract the presence of the disorder in the recipient. The term "prevention" means that the progression of the disease is reduced and / or eliminated, or that the onset of the disease is eliminated. The term "administer" means any method for providing a subject with a substance, which includes orally, intranasally, parentally (intravenously, intramuscularly, or subcutaneously), rectally, topically or intraocularly. The term "animal" means the definition of the animal kingdom. The term "target animal" refers to an animal which functions as the egg-producing animal or egg product. The term "subject animal" refers to the animal to which the egg or egg product produced by the target animal is administered. The term "immunogen" means a substance that is capable of inducing a humoral antibody and / or a cell-mediated immune response rather than immunological tolerance. He . term means the ability to stimulate an immune response as well as react with the products of this, for example, an antibody. The Invention The present invention comprises a combination of hyperimmunized egg product and glucosamine. According to the principles of the invention, a combination of hyperimmunized egg product and glucosamine, in exogenous amounts, is provided to a subject who experiences an inflammatory reaction in order to reduce inflammation. In a preferred embodiment, the invention comprises an egg or hyperimmune egg product in combination with glucosamine which when administered to a subject animal is effective in reducing inflammation and in treating and preventing arthritis and / or an autoimmune disease in that animal subject. The hyperimmune egg is preferably obtained from an egg-producing animal, and more preferably, a bird, which has been hyperimmunized with at least one immunogen. The hyperimmune egg product plus glucosamine is one which is preferably administered orally to the subject animal. The egg or hyperimmune egg product and / or glucosamine can also be separated into more potent fractions which can be subsequently administered to a animal subject in a variety of ways. It is further contemplated that the glucosamine and the egg product may be administered separately but preferably simultaneously. Glucosamine and the proposed or hyperimmunized egg product work synergistically to reduce inflammation when administered in combination to a subject. Glucosamine Glucosamine provides the primary substrate for both the synthesis of collagen and proteoglycan. The administration of glucosamine to a subject derives glucose to glucosamine at a rate-limiting step in the collagen and proteoglycans' natural production as the production of additional amounts of collagen and proteoglycans becomes available for use by the processes of the subject's natural healing to repair the connective tissue. Glucosamine is, preferably, in a salt form to facilitate its administration and uptake by the subject. The preferred salt forms are glucosamine hydrochloride and glucosamine sulfate, among others. It is believed by many that the use of the glucosamine without salt fails to provide the bioavailable glucosmaine since the compound is not absorbed in the gastrointestinal tract. It is indicated that in the case of glucosamine sulfate, the sulfate may be available for late use to catalyze the conversion of glucosamine to glycosaminoglycans. The unsulfated form is desired for the production of hyaluronic acid. With regard to the administration of glucosamine, it is rapidly and almost completely absorbed in humans and other animals through oral administration and, as such, oral administration is more preferred. A significant portion of the ingested glucosamine localizes to the cartilage and joint tissues, where it remains for long periods of time. This indicates that oral administration of glucosamine reaches the connective tissues, where glucosamine is incorporated into newly synthesized connective tissue. Egg product The egg product is any egg or egg fraction obtained from an egg-producing animal. In a preferred embodiment, the egg product of the invention is an egg obtained from a bird which has been manipulated, such as by hyperimmunization, to produce inter alia supranormal levels of an anti-inflammatory composition in the egg (See U.S. Application Serial No. 09/233, 379). Hyperimmunization of the egg product animal The egg or hyperimmune egg product can be produced by any egg-producing animal. It is preferred that the animal be a member of the class Birds, or, in other words, a bird. Within the Aves class, domesticated birds are preferred, but other members of this class, such as turkeys, ducks, and geese, are a suitable source of hyperimmune egg product. When such egg producing animals are brought to a specific state of immunization by means of, for example, periodic booster administrations of immunogens, the animals will produce eggs which, when consumed by a subject, will have beneficial properties, which include supranormal levels. of the anti-inflammatory composition, which when administered in combination with glucosamine are effective in the treatment and prevention of diseases related to inflammation as well as autoimmune diseases in that subject. The induction of the immune sensitivity alone is inefficient to cause the appearance of supranormal levels the anti-inflammatory composition of egg in eggs, as shown by the fact that table eggs do not contain these supranormal levels, although birds have been sensitized against several immunogens during immunization against bird diseases and during normal exposure to environmental factors. It is only in the specific hyperimmune states that the eggs have the desired supranormal levels of the anti-inflammatory composition. This special state of hyperimmunization, in which the egg will become effective, partly because it will contain higher levels of the anti-inflammatory composition, is preferably achieved by administering an initial immunization, followed by periodic boosts with sufficiently high doses of specific immunogens or mixtures of immunogens. The preferred dose of booster should be equal to or greater than 50% of the dose necessary to produce primary immunization of the bird. In this way, there is a threshold booster dose below which the properties in the bird's egg do not occur, even though the bird is in what may normally be called an immune state. Having knowledge of the requirement for the development and maintenance of a hyperimmune state, it is within the experience of the technique to vary the. amount of immunogen administered, depending on the genus of the egg-producing animal and strain used, in order to keep the animal in the hyperimmune state. The hyperimmune state is preferably produced by any immunogen or combination of immunogens. Hyperimmunization is preferably achieved by multiple exposures to multiple immunogens, multiple exposure to simple immunogens, or simple exposures to immunogenic libraries. Almost any immunogen can be used to induce the hyperimmune state, which includes, but is not limited to, bacterial, viral, protozoal, allergenic, fungal or cellular substances. Having known of the requirement to develop and maintain a hyperimmune state, it is within the scope of the art to vary the amount of the immunogen administered, depending on the animal genus that produces the egg and the strain employed, in order to keep the animal in the hyperimmune state. . In addition to immunizations with naturally occurring immunogens, immunization can also be performed using immunogens which are synthetically derived by combinatorial chemistries. The basic strategy is to join multiple combinations of chemical building blocks to produce a population of molecules with diversity. Several methods have recently been developed by solid-phase combinatorial synthesis and solution of oligomer libraries (Fodor, S. et al., Science 251: 767 (1991); Houghton, R. et al., Nature 354: 82 (1991 )) as well as small organic molecules (Bunin, B. &Ellman, J., J. Am. Chem. Soc. 114: 10997 (1992)). The synthesis of fast multiple peptides and oligomers can serve as a source for combinatorial derived immunogens. Additionally, an alternative strategy may allow the addition of organic building blocks in the combinatorial form for a major structure molecule for improved immunogenicity. Alternative modes of hyperimmunization of egg producing animals may be used in place of immunogenic vaccines and include the use of genetic vaccines. In particular, any DNA construct (generally consisting of a promoter region and a sequence encoding an antigen) will trigger an immune response. Genetic vaccines consist of vectors encoding antigens, naked DNA fragments, plasmid DNA, DNA-RNA antigens, protein-DNA conjugates, liposome-DNA conjugates, DNA expression libraries, and viral and bacterial DNA supplied to produce an immune response. DNA delivery methods include particle bombardment, direct injection, viral vectors, liposomal and jet injection, among others. When these delivery methods are applied, many smaller amounts may be necessary and generally result in more persistent immunogen production. When such genetic processes are used, the preferred method for introducing DNA into birds is through the intramuscular injection of DNA into the chest muscle. Methods of DNA delivery include, but are not limited to, particle bombardment, direct injection, liposomal, jet injection (Finan, EF et al., Proc. Nati, Acad. Sci. USA 90: 11478-11482 ( 1993)). Nucleic acids encoding known or unknown immunogens, promoter regions (notably CMV cauliflower mosaic virus) and bacterial origin SV40 can be replicated in bacteria to produce plasmid DNA for use in DNA injections. Although several routes of parental DNA administration are effective in chickens, the preferred method is intramuscular injection for the chest muscle. Vaccine tests are carried out on birds that leave eggs, preferably chickens. The Repeated immunizations are given at intervals of one to two weeks for up to six months. It is preferred that the amounts of DNA used are generally in the order of 50-300 ug of DNA in saline by direct injection. For particle bombardment, 4-100 ug of DNA coprecipitated in gold beads is preferred by the addition of 2.5 M CaCl2. Repeated immunizations can be given intradermally by this method of accelerating DNA coated particles in the live animal. The following is a detailed description of a preferred method for bringing an egg producing animal to a high state of immunity from which the resulting egg or hyperimmunized egg product can be administered to a subject: 1. Select one or more immunogens . 2. To produce an immune response in the egg-producing animal by primary immunization. 3. Administer immunogenic booster vaccines of appropriate dose to induce and maintain the hyperimmune state. 4. Test hyperimmune eggs for levels of anti-inflammatory activity. 5. Collect and process the eggs.

The following is a more detailed description of this procedure. Stage 1: Any immunogen or combination of immunogens can be used as a vaccine. The immunogens can be bacterial, viral, protozoan, fungal, cellular or any other substances to which the immune system of an egg-producing animal will respond. The critical point at this stage is that the immunogen must be able to induce the immune and hyperimmune states in the egg producing animal. Although only a single immunogen can function as the vaccine for the method of the invention, a preferred vaccine is a mixture of bacterial and viral polyvalent antigens selected from the following families of antigens: the enteric bacilli and bacteroides, pneumococci, pseudomonas, salmonella, streptococci, bacilli, staphylococci, neiseria, clostridia, mycobacteria, actinomycetes chlamydia, and mycoplasma . Viral antigens are preferably selected from the following families of antigens: adenovirus, picornavirus and herpes virus, although other families of viral antigens will work. In a preferred embodiment, a polyvalent vaccine referred to as PL 100 is used. The bacteria included in the PL-100 vaccine are listed in Table 1 of Example 1. This vaccine has been previously described in U.S. Patent No. 5,772,999 and U.S. Patent Application Serial No. 09 / 233,379 both assigned to DCV, Inc. Stage 2: The vaccine can be either a live or dead attenuated vaccine and can be administered by any method which produces an immune response. It is preferred that the immunization be performed by administering the immunogens through intramuscular injection. The muscle preferred for injection in a bird is the chest muscle. The dose is preferably 0.05-5 milligrams of the immunogenic vaccine. Other methods of administration that can be used include intravenous injection, intraperitoneal, intradermal, rectal suppository, aerosol, oral, topical or ocular administration. When DNA techniques are used for the hyperimmunization process, much smaller amounts are required, usually 300 micrograms. It can be determined if the vaccine has produced an immune response in the egg-producing animal through a number of methods known to those having experience in the immunology technique. Examples of these include immunoabsorbent assays linked to enzyme (ELISA), tests for the presence of antibodies to the stimulating antigens, and tests designed to evaluate the ability of immune cells from the host to respond to the antigen. The minimum dose of antigen needed to induce an immune response depends on the vaccination procedure used, which includes the type of adjuvants and formulation of antigens used as well as the type of egg producing animal used as the host. Step 3: The hyperimmune state is preferentially induced and maintained in the target animal by repeated booster administrations of an appropriate dose at fixed time intervals. The time intervals are preferably ranges of 2-8 weeks over a period of 6-12 months. However, it is essential that booster administrations do not lead to immune tolerance. Such processes are well known in the art. It is possible to use other hyperimmunization maintenance procedures or combination of procedures, such as, for example, intramuscular injection for primary immunization and intravenous injection for booster injections. In addition, the procedures include simultaneously administering microencapsulated and liquid antigen, or injection intramuscular for primary immunization, and booster doses by oral administration or parental administration by means of microencapsulation. Several combinations of primary and hyperimmunization are known to those skilled in the art. Stage . It is appropriate to test the eggs for levels of anti-inflammatory activity. This can be done by any clinical and preclinical evaluation that tests the effects of both the hyperimmune egg, or products derived from it, on inflammation. Stage 5: This stage involves the collection and processing of hyperimmunized eggs. The egg can be harvested by conventional methods. Egg processing can be done in a variety of ways described later in this document. The egg can also be further processed to purify the anti-inflammatory compositions as described in US Serial No. 09 / 233,379. Processing and Administration It is preferred that the eggs or fractions thereof, including the partially purified anti-inflammatory composition, harvested from the hyperimmunized animals be processed to produce a hyperimmune egg product, which may be subsequently administered to an animal subject in combination with glucosamine to treat an inflammatory disorder. The same egg or fractions thereof, including the partially purified anti-inflammatory composition of the present invention, are administered to a subject animal in combination with glucosamine by any means that treats or prevents inflammation, including arthritis, and / or an autoimmune disease in the subject animal. It is preferred that administration occurs by directly feeding the egg or any egg derivative in combination with the glucosamine for the subject animal. It is important to note that the whole egg, egg yolk, and egg white are natural food ingredients which are non-toxic and safe. In an alternative embodiment, the glucosamine and the egg or any fraction thereof, including the partially purified anti-inflammatory composition, are integrated into a nutritional supplement. With particular aspect to the egg, a preferred method to prepare the egg or any fraction thereof to be incorporated in a nutritional supplement involves drying the egg in egg powder. Although several methods for drying eggs are known, spray drying is a method favorite. The process of egg spray drying is well known in the art. Such egg dry powder can be incorporated into beverages in the form of, for example, protein powders, energy-forming beverages, protein supplements and any other nutritional products, associated with athletes. In addition, egg powder can be used in baking mixes, energy bars, candies, cookies, etc. Other examples of egg processing include making an omelet, a boiled or lukewarm egg, baking the egg, or, if desired, the egg can be eaten raw or processed as a liquid egg. The inventors suggest that glucosamine and egg, although preferably administered in combination, do not need to be administered in the same form or in a product. For example, glucosamine can be taken in the form of a pill while the egg product is administered as a beverage. A person should prefer to combine the partially pure anti-inflammatory composition with glucosamine, then the egg can even be further separated to purify the partially purified anti-inflammatory composition, as described above which will allow other modes of administration such as administering separately the egg product parentally, subcutaneously, intravenously, intramuscularly, intraperitoneally, intranasally, orally or topically. In addition, such additional separation will provide the ability to make encapsulated products and pharmaceutical compositions with the egg or fraction thereof. Preparations of the anti-inflammatory composition for parental administration include aqueous or non-aqueous solutions, suspensions or sterile emulsions. Examples of non-aqueous solvents or vehicles are propylene glycol, polyethylene glycol, vegetable oils such as olive oil and injectable organic esters such as ethyl oleate. With particular reference to the partially pure anti-inflammatory composition, oral administration is preferably carried out through the solid dosage forms which include capsules, tablets, pills, powders and granules, among others. In the solid dosage forms, the anti-inflammatory composition is mixed with at least one inert diluent such as sucrose, lactose or starch. Such dosage forms may also comprise, as is normal practice, additional substances other than inert diluent. In the case of capsules, tablets and pills, dosage forms they may also comprise buffering agents, pH sensitive polymers, or any other slow release encapsulants which are typically used as encapsulating compositions. in the food and drug industry. The tablets and pills can be further prepared with an enteric coating. Liquid dosage forms of the anti-inflammatory composition for oral administration include pharmaceutically acceptable emulsions, solutions, suspensions, syrups and elixirs, which contain inert diluents commonly used in the pharmaceutical art. In addition to the inert diluents, the compositions may also include wetting agents, emulsifiers, and suspending agents and sweeteners. Combination of glucosamine and the immunized egg product Glucosamine and the egg product, as described above, work synergistically, when administered concurrently to a subject, to reduce inflammation in that subject. With respect to the administration of both glucosamine and the immunized egg product, in a In an embodiment, an effective amount of glucosamine is administered to the subject independently of an effective amount of the immunized egg product. In an alternative embodiment, the subject is administered a composition which comprises an effective amount of glucosamine and immunized egg product. Any method of administration will effect a synergistic effect. Administration to the subject should be done in an amount that is effective in treating or preventing inflammation. It is preferred that the subject be administered with a higher dose of the glucosamine mixed with a lower dose of the immunized egg product. Depending on the particular disorder, it may be more preferred in reverse, then such unequal doses are appropriate for treatment and prevention, and should be administered in those amounts. Due to the synergistic effect of these two compositions, the administration may need to be adjusted accordingly. Those skilled in the art are familiar with determining the quantities of doses that treat better and avoid the inflammation of interest. The glucosamine and egg of the present invention can be administered by any means that provides anti-inflammatory activity. For example, the administration can be parental, subcutaneous, intravenous, intramuscular, intraperitoneal, intranasal or oral. Oral administration is preferably carried out through solid dosage forms which include capsules, tablets, pills, powders and granules, among others. In the solid dosage forms, the egg product and the glucosamine are mixed with at least one inert diluent such as sucrose, lactose or starch. Such dosage forms may also comprise, as is the practice standard, additional substances other than inert diluent. In the case of capsules, tablets and pills, the dosage forms may also comprise buffering agents, pH sensitive polymers, or any other slow release encapsulants which are typically used as encapsulating compositions in the food and drug industry. The tablets and pills can be further prepared with an enteric coating. The liquid dosage forms of the combination of glucosamine and the egg product for oral administration include pharmaceutically acceptable emulsions, solutions, suspensions, syrups and elixirs, which contain inert diluents commonly used in the pharmaceutical art. In addition to the inert diluents, the compositions may also include wetting agents, emulsifying and suspending agents, and sweeteners. The preparations of the combination of glucosamine and the "egg product for parental administration include sterile aqueous or non-aqueous solutions, suspensions or emulsions Examples of non-aqueous solvents or vehicles are propylene glycol, polyethylene glycol, vegetable oils such as olive oil and Injectable organic esters such as ethyl oleate The dose of the active ingredients may be varied, however it is necessary that the amount of the active ingredient must be such that a suitable dosage form is obtained. selected depends on the desired therapeutic effect, in the route of administration and on the duration of treatment.The dose of administration and frequency will depend on the age and general health condition of the patient, taking into consideration the possibility of side effects. administration will also depend on concurrent treatment with other drugs and the patient's tolerance of the drug administered.

With respect to the administration to a subject of the hyperimmunized egg or egg product, it has been determined, and is detailed in the following examples, that the preferred dose range of hyperimmunized egg or egg product to be given to a subject is between 100 and 100. milligrams at 10 grams per kilogram of subject weight. With respect to . the same partially purified anti-inflammatory composition, it has been determined that the preferred dose range of the partially purified, purified and isolated composition from the whole egg, egg yolk and egg white of a hyperimmunized egg, is between 1 microgram and 400 milligrams per kilogram of the anti-inflammatory composition. With respect to the administration to a subject of glucosamine, it has been determined, and is detailed in the following examples, that the preferred dose range of glucosamine to be given to a subject is between 10 milligrams to 5 grams per kilogram of weight of the subject. And more preferably, 100 milligrams to 2.5 grams of the subject's weight. In a preferred embodiment, a subject of 50 pounds (22.68 Kg) suffering from inflammation should be administered with a tablet, twice a day, which comprises 250 mg of glucosamine HC1, 750 mg of product of hyperimmunized egg and 320 mg of coated ester C. Administration is continued as necessary to reduce or prevent inflammation. The duration and intensity of the treatment will depend on the particular condition and the progress of the condition of the subject. Examples of inflammatory conditions that can be treated by administration of the glucosamine and the egg product of the present invention include all forms of arthritis, which include, but are not limited to, rheumatoid arthritis, osteoarthritis, ankylosing seronegative spondyloarthropathy, reactive arthritis, chronic fatigue syndrome, fibromyalgia (fibrositis) and gout. The egg product of the invention is equally effective in treating autoimmune diseases, such as rheumatoid arthritis, juvenile diabetes, multiple sclerosis, Graves' disease, Meneri's disease, myasthenia gravis, lupus erythematosus, psoriasis, systemic sclerod, rheumatic fever, syndrome of Sjogren among others; acute and subacute bursitis, acute nonspecific tendonitis, systemic lupus erythematosus, systemic dermatomyositis, acute rheumatic carditis, pemphigus, bullous dermatitis, .. herpeteformis, severe erythema, multiform exfoliative dermatitis, cirrhosis, seasonal perennial rhinitis, bronchial asthma, dermatitis ectopic, serum disease, keratitis, ophthalmic iritis, diffuse ureitis, corditis, optic neuritis, sympathetic ophthalmia, symptomatic sarcoidosis, Loeffler's syndrome, berylliosis, hemolytic anemia, mastitis, mastoiditis, contact dermatitis, allergic conjunctivitis, psoriatic arthritis, ankylosing spondylitis, arthritis of acute gout, rheumatoid arthritis of herpes zoster, osteoarthritis, any other degenerative diseases, and any other related autoimmune diseases. In addition, the combination of glucosamine and the egg product can be used to treat individuals who are exposed to potentially inflammatory agents such as allergens. When it comes to the treatment and prevention of a particular disorder, whether for inflammation in general or a form of arthritis or an autoimmune disease, glucosamine in combination with the hyperimmune egg product or any active fraction thereof, which includes the anti-inflammatory composition partially purified, is preferably administered to the subject in an amount that is immunologically effective to treat and prevent the particular disorder. The duration and intensity of the treatment will depend on the particular condition, whether it is present and, if present, the progress of the condition of the subject. Glucosamine in combination with the hyperimmune egg product or any active fraction thereof, including the partially purified anti-inflammatory composition, are also provided in any amount that treats and / or avoids the condition and symptoms of the condition. For example, in some cases, the daily amounts that are in the range of less than one to several hyperimmune, whole eggs (or hyperimmune egg product which contain the equivalent of less than one to several whole, hyperimmune eggs) can be administered in combination with an effective dose of glucosamine to the subject depending on the particular circumstance of the condition. The most potent fractions can be separated and concentrated by methods described herein as well as other methods known in the art. The dose of the active ingredients can be varied; however, it is necessary that the amount of the active ingredient must be such that a suitable dosage form is obtained. It will be recognized that the dosage form selected depends on the desired therapeutic effect, on the route of administration and on the duration of the treatment.

The advantageous properties of this invention can be observed by reference to the following examples which illustrate the invention. EXAMPLES EXAMPLE 1 Preparation of the PL-100 vaccine A bacterial culture which contains the spectrum of bacteria shown in Table 1 below, as obtained from the American Type Culture Collection, is reconstituted with 15 ml of medium and incubated during incubation. night at 37 ° C. Once good growth is obtained, approximately half of the bacterial suspension is used to inoculate one liter of broth with the inoculated one that is incubated at 37 ° C. After a good growth in the culture is visible, the bacterial cells are harvested by centrifugation of the suspension for 20 minutes to eliminate the medium. The obtained bacterial granule is resuspended in sterile saline and the bacterial sample is centrifuged three times to wash the medium from the cells. After the third wash with sterile saline, the bacterial granule is resuspended in a small amount of distilled water twice.

The medium-free bacterial suspension is killed by placing the suspension in a glass flask in a 80 ° C water bath overnight. The viability of the broth culture is tested with a small amount of dead bacteria, incubated at 37 ° C for five days and checked daily for growth to certify that the bacteria are dead. The dead bacteria are lyophilized until dry. The dried bacteria are then mixed with sterile saline at a concentration of 2.2 x 10 8 bacterial cells / ml of saline (1.0 optical density reading at 660 nm). The bacteria contained in the PL-100 vaccine are listed in Table 1 below. TABLE 1 Bacterial List PL-100 Escheric ia coli Escheric ia coli (Aerobacter) Klebsiella pneumoniae Pseudomonas aeruginosa Salmonella typhimurium Salmonella dysenteriae Salmonella enteriditis Salmonella epidermis Salmonella simulans Streptococcus, pyogenes, type 1 Streptococcus pyogenes, type 3 Streptococcus pyogenes, type 5 Streptococcus pyogenes, type 8 Streptococcus pyogenes, type 12 Streptococcus pyogenes, type 14 Streptococcus pyogenes, type 18 Streptococcus pyogenes, type 22 Pseudomonas vulgaris Streptococcus agalactiae Streptococcus mitis Streptococcus mutans Streptococcus salavarius Streptococcus sanguis Streptococcus pneumoniae Propionibacterium acnes Haemophilis influenzae Immunization procedure for the hyperimmunized egg product A dead pathogen preparation is prepared as described above. For the first vaccination, the bacteria are mixed with Freund's complete adjuvant, and 5.6 mg of bacterial material is injected into the breast muscle of a chicken. For the remaining vaccines, the bacterial preparation is mixed with Freund's complete adjuvant and injected into the chickens at two-week intervals for six months. EXAMPLE 2 Objective To evaluate the synergistic anti-arthritic effect of glucosamine hydrochloride and the hyperimmune egg of DCV in established rat adjuvant arthritis, a model of chronic animal inflammation. Results Table 1 shows all the data of paw edema on days 14, 22 and 30 of the study. The results indicate that the group of PL-100., + Glucosamine HC1 show the highest inhibition percentage of inflammation ^ on days 14 and 30 of the disease. The PL-100 egg and glucosamine hydrochloride by themselves show the inhibitory effect on days 14 and 22 of the study, while both show ineffectiveness at day 30 when the disease has progressed rapidly to severe polyarthritis. Table 2 shows all levels of serum fibrinogen on days 16, 23 and 30 of the study. The results indicate that Fibrinogen levels initially increase on day 16 followed by a drop in levels on day 23 and 30. However, the increase in levels on day 16 is at least in the PL group -100 + glucosamine HCl compared to PL-100 and glucosamine HCl alone, and also the inhibition of serum fibrinogen levels is higher in the PL-100 + glucosamine HCl group compared to the PL-100 group and Glucosamine HCl individually. Also, on day 30, the percentage of inhibition of fibrinogen levels in the PL-100 + glucosamine HCl group is 32% compared to 46% in the group treated with indomethacin. Table 3 shows all the histomorphological observations on day 22 and 30 of the study. The results show that tissue inflammation periarticular / soft, (which indicates the infiltration of mononuclear and / or polymorphonuclear inflammatory cells into soft tissues, which include synovial membranes around the joint) is at least affected in the PL-100 + glucosamine group both in the day 22 and 30 compared with the other groups. The hyperostosis condition, (which indicates increased and excessive amounts of new bone growth, particularly in subperiosteal areas) is at least in the PL + 100 + HC1 group of glucosamine on day 22 and low on day 30 compared to the other groups. Cartilage erosion on day 22 and 30 is at least in the PL-100 + HC1 group of glucosamine compared to the other groups. Pannus cartilage, (an accumulation of inflammatory cells, exudate, fibrin or fibrous tissues on the surfaces of the joints) is affected at least on day 22 and 30 in the group treated with PL-100 + glucosamine HC1 compared to other groups. Ankylosis, (which denotes elongated and immobile joints due to the formation of fibrous and inflammatory tissues between the surfaces of the joints, usually with complete loss of cartilage and replacement in this area with fibrous tissue which results in adhesions and joint cavities) is minimal in the PL-100 + HC1 group of glucosamine compared to any other group. Finally, osteolysis (which indicates necrosis and bone lysis) is absent in the group treated with PL-100 + HC1 glucosamine on day 22 compared to the other groups, where there is some degree of lysis present. Table 1 Rat Adjuvant DCV Effect of immune egg preparations, glucosamine, individually and in combinations, and CAF in the rat established adjuvant arthritis model give the test items in 1 ml of deionized water, when not in a combination 1 my extra water is given to each rat b - normal growth of the claw * P < 0.05 from the control adjuvant (Dunnett's test) Table 2 DCV rat adjuvant Effects of immune egg preparations, glucosamine, individually and in combinations with PL-100 and chondroitin S04, and CAF in the established adjuvant arthritis model of rat a - control fibrinogen levels since indomethacin is not dosed until day 16. One of the plasma samples is coagulated < 0.05 of Dunnett's test Table 3 Incidence of histomorphological observations Key: 0 within normal limits 1 minimum degree or amount of change indicated 2 medium degree or amount of change indicated 3 moderate degree or amount of change indicated 4 various degrees or amount of change indicated Summary In the rat adjuvant arthritis model, which is a chronic animal model for inflammation, the egg PL-100 and the HC1 of glucosamine show an additive effect in a) reduce the swelling of the pad of the left leg of the animal, therefore the anti-inflammatory effect is shown in on days 14, 22 and 30, b) reduce the serum levels of fibrinogen (which is an accepted serum marker for inflammation) after day 22 of the injection, and continue until day 30, which is the end of the study, c) minimize the effect on the periarticular / soft tissues from the infiltration of mononuclear and polymorphonuclear cells on day 22, when the intensity of rheumatoid arthritis is at its peak, d) completely protects from hyperostosis on day 22 of the study, e) completely protects cartilage erosion around the arthritic joints, on day 22 and minimizes damage on day 30, f) completely protects the cartilage in the pannus area on day 22, and minimizes damage on day 30, g) completely protects the affected joints from ankylosis on day 22, completely protects the bones in the area of arthritic arthritic activity from osteolysis on day 22. h) Figure 2 shows All data on foot edema on days 14, 22 of the study. The results indicate that the group of PL-100"+ glucosamine HC1 show the highest percentage of inhibition on day 14 of the disease. i) Figure 2 shows the serum levels of fibrinogen on days 16, 23 and 30 of the study. The results indicate that fibrinogen levels initially increase on day 16 followed by a drop in levels on day 23 and 30. However, the increase in levels in the. day 16 is at least in the PL-100 + glucosamine HCl group compared to the PL-100 + glucosamine HCl alone, and also the inhibition of serum fibrinogen levels is higher in the PL-100 + HCl group glucosamine compared to the PL-100 and glucosamine HCl groups individually. Also, on day 30, the percentage inhibition of fibrinogen levels in the PL-100 + glucosamine HCl group is 32% compared to 46% in the group treated with indomethacin. In this way PL-100 + glucosamine HCl not only restricts the severity of inflammation at the onset of the disease, but also inhibits towards the end of the study (as indicated by the levels of inflammatory serum markers). It is noted that in relation to this date, the best method known by the applicant to carry the practice said invention is that which is clear from the present description of the invention.

Claims (45)

1. CLAIMS Having described the invention as above, the content of the following claims is claimed as property: 1. A composition characterized in that it comprises glucosamine and an egg product.
2. 2. The composition according to claim 1, characterized in that the glucosamine is selected from the group comprising HC1 of glucosamine and glucosamine sulfate.
3. 3. The composition according to claim 1, characterized in that the egg product is selected from the group consisting of whole egg, egg yolk, egg white and any fraction thereof.
4. 4. The composition according to claim 1, characterized in that the egg product is obtained from an egg producing animal which has been hyperimmunized with an immunogenic or genetic vaccine.
5. The composition according to claim 4, characterized in that the immunogenic vaccine comprises at least one antigen selected from the group consisting of immunogens bacterial, viral, protozoal, fungal and cellular and mixtures thereof.
6. 6. The composition according to claim 4, characterized in that the genetic vaccine comprises at least one DNA construct encoding an immunogen selected from the group consisting of naked DNA fragments, plasmid DNA, viral DNA, bacterial DNA, DNA expression libraries, DNA-RNA immunogens, protein-DNA conjugates, and liposome-DNA conjugates, and mixtures thereof.
7. The composition according to claim 1, characterized in that the egg product further comprises an anti-inflammatory composition.
8. The composition according to claim 1, characterized in that the amount of the egg product comprises between about 100 milligrams and 10 grams of whole egg per kilogram of weight of a subject to which the composition is administered, or the equivalent thereof for a fraction of the whole egg.
9. 9. The composition according to claim 1, characterized in that the amount of the glucosamine comprises between about 10 milligrams and 5 grams.
10. 10. A method for reducing inflammation in a subject, the method characterized in that it comprises administering to a subject an effective amount of glucosamine and an egg product.
11. 11. The method according to claim 10, characterized in that the glucosamine is selected from the group comprising glucosamine HC1 and glucosamine sulfate.
12. The method according to claim 10, characterized in that the egg product is selected from the group which consists of whole egg, egg yolk, egg white and any fraction thereof.
13. 13. The method according to claim. 10, characterized in that the egg product is obtained from an egg producing animal which has been hyperimmunized with an immunogenic or genetic vaccine.
14. The method according to claim 13, characterized in that the immunogenic vaccine comprises at least one antigen selected from the group consisting of bacterial, viral, protozoan, and cellular immunogens and mixtures thereof.
15. 15. The method according to claim 13, characterized in that the genetic vaccine comprises at least one DNA construct encoding the immunogen selected from the group consisting of naked DNA fragments, plasmid DNA, viral DNA, bacterial DNA, libraries of DNA expression, DNA-RNA immunogens, DNA-protein conjugates, and liposomal-DNA conjugates, and mixtures thereof.
16. 16. The method according to claim 10, characterized in that the egg product further comprises an anti-inflammatory composition.
17. The method according to claim 10, characterized in that the effective amount of the egg product administered is between about 100 milligrams and 10 grams of the whole egg per kilogram of body weight, or the equivalent thereof for a fraction of the whole egg.
18. 18. The method according to claim 10, characterized in that the effective amount of glucosamine administered is between about 10 milligrams and 5 grams.
19. 19. A method for reducing serum fibrinogen levels is the method characterized in that it comprises administer to the subject an effective amount of glucosamine and an egg product.
20. The method according to claim 19, characterized in that the glucosamine is selected from the group comprising the HC1 of glucosamine and glucosamine sulfate.
21. The method according to claim 19, characterized in that the egg product is selected from the group consisting of whole egg, egg yolk, egg white and any fraction thereof.
22. 22. The method according to claim 19, characterized in that the egg product is obtained from an egg producing animal which has been hyperimmunized with an immunogenic or genetic vaccine.
23. 23. The method according to claim 22, characterized in that the immunogenic vaccine comprises at least one antigen selected from the group consisting of bacterial, viral, protozoal, fungal and cellular immunogens and mixtures thereof.
24. 24. The method according to claim 22, characterized in that the genetic vaccine comprises at least one DNA construct encoding an immunogen selected from the group consisting of naked DNA fragments, plasmid DNA, viral DNA, bacterial DNA, DNA expression libraries, DNA-RNA immunogens, protein-DNA conjugates and DNA-liposome conjugates, and mixtures thereof.
25. 25. The method according to claim 19, characterized in that the egg product further comprises an anti-inflammatory composition.
26. 26. The method according to claim 19, characterized in that the effective amount of the administered egg product is between about 100 milligrams and 10 grams of whole egg per kilogram of body weight, or the equivalent thereof for a fraction of the whole egg.
27. 27. The method according to claim 19, characterized in that the effective amount of the glucosamine administered is between about 10 milligrams and 5 grams.
28. 28. A method for reducing or preventing the onset of rheumatoid arthritis The method is characterized in that it comprises administering to the subject an effective amount of glucosamine and an egg product.
29. 29. The method according to claim 28, characterized in that the glucosamine is selected from the group comprising glucosamine HC1 and glucosamine sulfate.
30. 30. The method according to claim 28, characterized in that the egg product is selected from the group consisting of whole egg, egg yolk, egg white and any fraction thereof.
31. 31. The method according to claim 28, characterized in that the egg product is obtained from an egg producing animal which has been hyperimmunized with an immunogenic or genetic vaccine.
32. 32. The method according to claim 31, characterized in that the immunogenic vaccine comprises at least one antigen selected from the group consisting of bacterial, viral, protozoal, fungal and cellular immunogens and mixtures thereof.
33. The method according to claim 31, characterized in that the genetic vaccine comprises at least one DNA construct encoding an immunogen selected from the group consisting of naked DNA fragments, plasmid DNA, viral DNA, DNA bacterial, DNA expression libraries, DNA-RNA immunogens, protein-DNA conjugates, and liposomal-DNA conjugates, and mixtures thereof.
34. 34. The method according to claim 28, characterized in that the egg product further comprises an anti-inflammatory composition.
35. 35. The method according to claim 28, characterized in that the effective amount of the administered egg product is between about 100 milligrams and 10 grams of whole egg per kilogram of subject weight, or the equivalent thereof for a fraction of the whole egg .
36. 36. The method according to claim 28, characterized in that the effective amount of glucosamine administered is between about 10 milligrams and 5 grams.
37. 37. A method for reducing or preventing the onset of osteoarthritis the method is characterized in that it comprises administering to the subject an effective amount of the glucosamine and an egg product.
38. 38. The method according to claim 37, characterized in that the glucosamine is selected from the group comprising glucosamine HC1 and glucosamine sulfate.
39. 39. The method according to claim 37, characterized in that the egg product is selected from the group consisting of whole egg, egg yolk, egg white and any fraction thereof.
40. 40. The method according to claim 37, characterized in that the egg product is obtained from an egg producing animal which has been hyperimmunized with an immunogenic or genetic vaccine.
41. 41. The method according to claim 40, characterized in that the immunogenic vaccine comprises at least one antigen selected from the group consisting of bacterial, viral, protozoal, fungal and cellular immunogens and mixtures thereof.
42. 42. The method according to claim 40, characterized in that the genetic vaccine comprises at least one DNA construct that encodes an immunogen selected from the group consisting of naked DNA fragments, plasmid DNA, viral DNA, bacterial DNA, libraries of DNA expression, DNA-RNA immunogens, protein-DNA conjugates and liposome-DNA conjugates and mixtures thereof.
43. 43. . The method according to claim 37, characterized in that the egg product also comprises an anti-inflammatory composition.
44. 44. The method according to claim 37, characterized in that the effective amount of the administered egg product is between about 100 milligrams and 10 grams of whole egg per kilogram of subject weight, or the equivalent thereof for a fraction of the whole egg .
45. 45. The method according to claim 37, characterized in that the effective amount of glucosamine. administered is between approximately 10 milligrams and 5 grams.