WO1998014209A1 - Administration orale d'anticorps a base de jaune d'oeuf de poule pour le traitement de maladies - Google Patents

Administration orale d'anticorps a base de jaune d'oeuf de poule pour le traitement de maladies Download PDF

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Publication number
WO1998014209A1
WO1998014209A1 PCT/US1997/017722 US9717722W WO9814209A1 WO 1998014209 A1 WO1998014209 A1 WO 1998014209A1 US 9717722 W US9717722 W US 9717722W WO 9814209 A1 WO9814209 A1 WO 9814209A1
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mediator
egg
cell
antibodies
hen
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PCT/US1997/017722
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English (en)
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Marilyn A. Coleman
Mitchell V. Kaminski
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Ovimmune, Inc.
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Priority to AU47419/97A priority Critical patent/AU729502B2/en
Priority to EP97909921A priority patent/EP0930891A4/fr
Priority to CA002267421A priority patent/CA2267421A1/fr
Priority to JP10516847A priority patent/JP2001501622A/ja
Priority to NZ335170A priority patent/NZ335170A/en
Publication of WO1998014209A1 publication Critical patent/WO1998014209A1/fr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/02—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from eggs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Definitions

  • the present invention relates to the preparation of egg antibody products which may be used to neutralize a wide variety of systemic pathogens in both human and non- human species, including those with failing, naive or compromised immune systems. Its most immediate application is believed to be in the support of patients with acquired immunodeficiency syndrome (ADDS), now widely regarded as the most devastating disease in the history of humankind.
  • ADDS acquired immunodeficiency syndrome
  • the AIDS infection is not as prevalent in the US as it is in countries in Africa or the Caribbean. AIDS is slowly spreading to all countries in the world. There were only 223 deaths from AIDS in Japan from July 1, 1992 until July 1, 1993. In the United States, one out of every 100 males and 1 out of every 800 females are currently HTV positive. It is no longer a "homosexual" disease. Today the fastest growing segment of the population is children born to HIV+ women who did not know that they carried the virus. The immunocompromised patient may be defined as an individual who is at increased risk for infection, often to a life-threatening extent.
  • the gastrointestinal tract is centrally involved in the infectious status of the immunocompromised patient. Enteric infections are common and can be accompanied by debilitating diarrhea and nutrient malabsorption. Enteric organisms are further implicated as a source of bacteremias and sepsis in immunocompromised patients. It is estimated that in the US alone more than 130,000 deaths last year are associated with bacteremia. A large proportion of these resulted from microorganisms that normally reside in the gut. Even organisms that normally are considered nonpathogenic may establish local infections of secondary bacteremias. Disabling gastrointestinal symptoms are prominent both in patients with established AIDS and in patients with earlier stages of human immunodeficiency virus (HTV) infection.
  • HTV human immunodeficiency virus
  • the intact immune system consists of two lines of defense which keep potentially pathogenic gastrointestinal organisms from binding to the intestinal lining.
  • immunity is a lymphocyte-dependent system whereby potential disease-causing organisms or substances present in an individual's intestine are "sampled" at thousands of sites throughout the small intestine known as Peyer's patches.
  • lymphocytes that identify proteins on the surface of organisms.
  • the most effective antibodies are those produced against adhesians also known as lectans.
  • Adhesians are the binding sites on organisms which adhere to susceptible receptor sites on tissue, thus becoming infected.
  • a receptor is usually a glycoprotein but can be a glycolipid or a peptide called integrin.
  • Lectans are a class of proteins on the infecting organism that can combine with these receptors rapidly, selectively and reversibly.
  • T-lymphocytes within the Peyer's patches pass anti-adhesian information to B-lymphocytes.
  • the B-lymphocytes pass into the circulating blood where they become plasma cells.
  • Plasma cells travel throughout the bloodstream and concentrate in areas where they produce specific antibody to coat moist surfaces and to prevent adhesion by the offending organisms. If a pathogenic organism cannot adhere to the tissue surface, it cannot proliferate and cause infection, circulatory antibodies perform this function in cells remote to the intestines.
  • mediators of inflammation e.g., tumor necrosis factor (TNF), interleukins 1, 6, and 8 (EL-l, -6, -8), etc.
  • TNF tumor necrosis factor
  • EL-l, -6, -8 interleukins 1, 6, and 8
  • EL-l, -6, -8 interleukins 1, 6, and 8
  • the resultant "cascade" is associated with the metabolic and physiologic changes of illness.
  • An incompetent intestine allows translocation of organisms and disease-associated factors, such as inflammatory mediators and endotoxins, from the intestinal lumen into the systemic circulation to cause disease at sites remote to the intestinal lumen.
  • Plasma cells are destroyed in HIV infection either directly or as a result of destruction of lymphocytes and pathways needed for their production.
  • HTV virus cannot be eradicated, the negative effects of reduced immunity to opportunistic infections can be controlled to some extent. Infection by these opportunistic organisms stimulates the production of inflammatory mediators, as described supra. Principal among them is TNF. In addition to being a major stimulator of metabolic and physiologic changes associated with illness, TNF turns on replication of the HTV virus. Thus, there exists a symbiotic relationship which results in progression of the HTV-infected patient toward AIDS.
  • TNF has also been identified as an important factor in causing deterioration of the brain and nervous system, pulmonary function, loss of appetite and further deterioration of the intestine leading to further opportunistic organism adhesion, diarrhea, and malabsorption.
  • the ensuing malnutrition itself is known to depress production of antibody and lymphocyte count.
  • the lymphocyte count drops acutely in response to any infection, particularly in response to TNF.
  • the systemic effect of an increasing rate of recurrent infections by opportunistic organisms will further suppress the lymphocyte count. It is the gut's involvement in the inflammatory process that causes the patient to lose his or her appetite and develop malabsorption, leading to malnutrition.
  • the patient suffers from a triple indemnity, viz., suppressed lymphocyte count from the virus, leading to a suppressed lymphocyte count from infection, which is then potentiated by malnutrition.
  • a triple indemnity viz., suppressed lymphocyte count from the virus
  • suppressed lymphocyte count from infection leading to a suppressed lymphocyte count from infection, which is then potentiated by malnutrition.
  • This is the mechanism whereby HTV-infected patients develop AIDS, waste, and die.
  • the virus itself does not cause the wasted appearance, nor is the individual's body mass being consumed by the virus. Rather, the wasted appearance is caused by the above chain of events leading to chronic infection, malnutrition and death.
  • Viruses include cytomegalovirus (CMV), herpes simplex virus (HSV), and papovavirus, of which CMV is by far the most devastating.
  • CMV infection may simultaneously or sequentially involve the entire gastrointestinal tract, and is extremely invasive and serious, producing systemic and localized symptoms of dysphagia, odynophagia, vomiting, abdominal pain, nausea, diarrhea with or without blood and mucus, episodes of megacolon and localized peritonitis, biliary obstruction, dementia and blindness.
  • Bacterial pathogens include the various forms of TB, Mycobacterium avium intracellulare (MAI), E. coli, Hemophilus, N. gonorrhoeae, Salmonella typhimurium, Campylobacter jejuni, Shigellaflexneri, and cholera. Patients with AIDS are especially susceptible to infection by S. typhimurium, which may result in life-threatening diarrhea and recurrent systemic bacteremia resistant to antibacterial therapy. MAI is the most common cause of disseminated bacterial infection in patients with AIDS. In normal or non-immunocompromised hosts, disease due to this organism is rare and clinical manifestations, if any, are primarily pulmonary.
  • MAI Mycobacterium avium intracellulare
  • E. coli E. coli
  • Hemophilus Hemophilus
  • N. gonorrhoeae Salmonella typhimurium
  • Campylobacter jejuni Salmonella typhimurium
  • MAI In AIDS patients, MAI typically causes a widespread infection with involvement of the bone marrow, spleen, lungs, lymph nodes, intestinal tract, brain, and adrenal glands.
  • Protozoa include Isospora, Pneumocystis carinii, Toxoplasma, Entamoeba histolytica, Giardia lamblia, and coccidia.
  • Symptoms of Paracytoxis infection in immunocompetent individuals are usually of short duration, with intestinal involvement resulting in moderate to severe diarrhea and possible weight loss. In immunocompromised individuals, however, infections can become persistent and life- threatening.
  • parasites In a small percentage of AIDS patients, parasites are invasive and can produce a syndrome of overwhelming chronic and large volume diarrhea, abdominal pain, hypovolemia, electrolyte disturbances, and nutritional deficiency.
  • Fungi include Candida albicans, and Cryptococcus, Histoplasma. Persistent oral candidiasis is seen in a large percentage of AIDS patients and is usually thought to herald the onset of "end stage” AIDS as it invades progressing to fungal septicemia and death.
  • Neutralizing antibody against a variety of pathogens e.g., rotavirus, cholera, enterotoxigenic E. coli, Streptococcus mutans, Salmonella, N. gonorrhea, HIV, TNF, EL-l, B -6, endotoxin, spider and snake venom, etc.
  • pathogens e.g., rotavirus, cholera, enterotoxigenic E. coli, Streptococcus mutans, Salmonella, N. gonorrhea, HIV, TNF, EL-l, B -6, endotoxin, spider and snake venom, etc.
  • Methods of production include genetically engineered bacteria, monoclonal hybridomas, and hyperimmunization of chickens and cows.
  • Such antibodies have been shown to neutralize the targeted pathogens in vitro and in vivo in the intestine at the pathogen/mucosa interface.
  • Recent publications have shown that in both animal species
  • hens Polyclonal antibodies (the type produced by hens) are not destroyed by the upper intestines. b. Since hyperimmunized hens produce polyclonal antibodies, there are many more sites for adhering to the disease-causing agent and the antibodies will perform better through multiple mutations of a disease, c. Each hen produces a relatively small volume of hyperimmune yolk. The product of multiple hens is blended to give a more uniform product.
  • Antibody from hyperimmunized hens have not been used in the past because there were concerns that the antibodies would not work across species. Experiments conducted in connection with the present invention have disproved this fear.
  • the present invention is directed to the use of egg antibody preparations in the treatment of systemic disease in human and non-human mammals.
  • IgY antibodies are first obtained from the egg of a domestic fowl hen which has been actively immunized against said one or more pathogenic organisms or noxious agents by injection with an immunogen containing immunogenic determinants specific to elicit such antibodies.
  • the procedure for injecting the hens with the immunogens was taken from Fertel et al, "Formation of antibodies to prostaglandins in the Yolk of Chicken Eggs," Biochem. Biophys. Res. Comm., 1981, 102: 1028-1033.
  • the antibodies then are administered orally to a mammal suffering from or to prevent an infectious or non- infectious systemic disease caused or exacerbated by such pathogenic organism or organisms or noxious agents.
  • This invention is thus capable of providing systemic passive immunity. Concentration of the antibody can be done, but it is unnecessary to separate the antibodies from the egg yolk, so processing and administration are convenient and inexpensive.
  • Antibody produced from egg yolks of hens immunized against specific antigens are effective in controlling noxious agents, whether viral, bacterial, fungal, protozoal, toxins, inflammatory mediators, prostaglandins, leukotrienes, thromboxines, sarcomas or carcinomas, not only within the bowel but also in tissues remote thereto.
  • the immunogenic determinant may comprise only a specific portion of the pathogenic organism, e.g., the loop or coat of a virus or the fimbria of a piliated bacterium.
  • the method of this invention has been shown to be efficacious in the treatment of septic shock in mice, and in lowering somatic cell count in dairy cattle.
  • the discovery disclosed herein shows that an egg antibody raised against any of the pathogenic organisms or molecules discussed in the Background can be effective in controlling this disease in tissue remote from the intestine, i.e., systemic disease.
  • the mucous membranes including the gastrointestinal tract, share in immunoglobulin secretion, a function distinct from other lymphoid tissues in the body.
  • Secretory immunoglobulins prevent the adherence of pathogens and other mucosae or most surfaces of the body and, thus, prevent their ability to cause disease. Proper function of the secretory immune system requires the coordinated activity of mucosae cells, antigen-processing cells, several classes of T cells, and plasma cells. A deficiency of secretory IgA, the major secretory immunoglobulin, may be associated with recurrent intestinal,
  • T-cell lymphocytes found in Peyer's patches process a pathogen's surface proteins, which are responsible for its binding to the intestinal mucosa. If there is no adhesion, there can be no disease. Thus, an antibody against these surface proteins can prevent binding and disease. Intestinal opportunistic organisms are not killed by such an antibody, but the antibody neutralizes the organisms preventing binding to the mucosa. While several factors interact to prevent potential pathogens from adhering to the mucosa, secretory IgA is specific and the cornerstone of all the defense mechanisms.
  • the primary defect in AIDS is felt to be the destruction of specific subsets of helper T lymphocytes, due to infection by the retrovirus HIV.
  • the immunological derangement is widespread, including functional abnormalities of T cells, B cells, antigen-processing cells, and macrophages.
  • mucous membrane infections such as CMV and MAI leading to invasion and disseminated disease or septocemia, implies that secretory immunity is impaired in patients with AIDS.
  • a newborn mammal is a good example of an immunologically incompetent individual and the benefits of passive immunity by the oral ingestion of antibody.
  • a newborn 's intestinal immunity is not capable of adult immunologic behavior, the neonate does not ordinarily succumb to organisms ingested from its environment that are potentially disease-causing and lethal. This is because the neonate's mother has already developed immunity against the organisms in her environment. She passes that immunity on to her offspring in the form of antibodies, by delivering high concentrations of antibody via her mammary gland into the mouth and intestine of the suckling neonate.
  • bovine secretory antibody provides passive immunity to an immunologically naive calf that renders the calf safe from all barnyard parasites, bacteria and fungi which the mother cow has ingested and has in her intestinal environment. It has been shown that, for the first 12 hours, the colostrum ingested by a calf passes directly into the blood as if it were given intravenously. Chickens also produce antibody to protect the baby chick from the barnyard's organism environment. In avian species, the progeny acquire passive immunity by the absorption of maternal antibodies transferred to the egg, particularly the yolk. Thus, baby chicks are born immunologically naive in terms of their own antibody production but are not harmed by barnyard pathogens because their mother has actively provided antibodies against all such pathogens in the yolk.
  • the antigen used in immunization of the hen is a bacterium which causes intestinal infectious diseases such as colibacillosis in calves or piglets
  • the antibody-containing yolk obtained from an egg of the immunized hen in the aforedescribed manner has an activity against the antigen and thus is effective in protection of calves or piglets from attack by the same bacterium used in the immunization.
  • laying hens may be immunized with a vaccine for pregnant sows in order to obtain high amounts of specific antibodies against porcine enteropathogenic E. coli strains.
  • the resultant antibody-containing eggs are then mixed with milk replacer and fed to piglets to treat intestinal colibacillosis.
  • the average egg contains 15 ml of yolk having 8 mg/ml of IgG, also referred to as IgY, or "yolk immunoglobulin.” This makes the chicken a much more efficient antibody producer than the cow. Chickens produce approximately 20 times more antibody per kg body weight than a cow does in colostrum. In addition to chickens, other domesticated fowl may also serve as sources of eggs, e.g., turkeys, ducks, geese, and the like.
  • the laying hen transfers all antibody isotopes found in the chicken to the egg, i.e., IgY, IgM, an IgA antibodies.
  • the yolk contains only IgY while IgM and IgA are found only in the white.
  • the chicken's serum IgY antibody level is reflected in the egg yolk shortly after a single administration of antigen (about one week).
  • Egg yolk contains 3-25 mg IgY/ml. Depending on its weight, therefore, each egg could provide 40-500 mg IgY.
  • egg yolk antibodies are numerous. Chicken antibodies do not react with mammalian complement, Fc receptors, protein A or protein G. Yolk antibodies show great acid and heat resistance. Extraction of yolk antibodies can be performed even on a large scale without costly investment. Concentrating the antibody from egg yolk is a relatively straightforward process. The antibody is not harmed by pasteurization. The FDA regards egg antibody as a food rather than a drug and has granted GRAS (generally accepted as safe) status thereto. Approval by the FDA for human use of egg antibody in the AIDS or other diseases is relatively unencumbered.
  • the net effect of treating the HIV patient with egg antibodies is not to prevent the virus from replicating, binding and translocating into the patient from the intestine, but rather to neutralize the virus in areas remote to the intestines. Regardless of the manner in which a patient becomes infected with the HIV virus, eventually the highest concentrations are found in the intestinal lamina intestinal. The virus incubates in this environment requiring TNF to initiate and speed replication. Thus, production of antibody to neutralize the HIV virus itself and the inflammatory mediator TNF is as important in slowing the disease as is neutralization of opportunistic organisms. Another approach might be described as "personalized" avian surrogate secretory IgA.
  • the stool of an HIV-positive patient contains the organisms from which that patient is likely to die. Therefore, in addition to producing antibody to neutralize the HIV virus and TNF, the stool of a patient could be collected, subcultured, combined, and sterilized and used to raise antibody in a colony of chickens dedicated to that individual.
  • Experiments have been performed comparing the antibody levels and effectiveness in fresh eggs, pasteurized egg yolk and dried egg yolk that indicate that the product is stable in all of these environments. The yolk would then contain antibody against everything in the intestine that would cross into the blood stream and make that individual "ill” as the immune system deteriorated. Just as a mother chicken passes immunity to its chick, this colony of chickens would pass the same immunity to the HIV-positive patient.
  • the stool of a patient positive for HIV could be cultured.
  • a "cocktail" of avian antibody raised against each organism would be blended to neutralize their ability to create systemic disease.
  • the fact that the egg antibody preparations disclosed herein have been found to be exceptionally useful with respect to the special needs of HIV patients should in no way be construed as limiting the invention to this particular class of patient. Burn patients, organ transplant patients, patients in intensive care units, and patients with autoimmune diseases provide further examples of individuals that might benefit from the present invention. Enteric infections which translocate systematically are major causes of problems in these patient populations as well.
  • Veterinary applications of the present invention include, surprisingly, the treatment of mastitis in dairy cattle, as disclosed in U.S. Pat. No. , cited above.
  • the hyperimmune yolk antibody works in the following manner, Note Fig. 1, 2.
  • the IgY molecule has a "Y" shape.
  • the tail of the Y has three constant amine acid configurations or domains on it that identify the chicken origin. We will call these CI, C2 and C3.
  • the higher of the "v" portion of the Y contains active particles of less than 100 amino acid units. This is called the hypervariable area (VlVh) and is the actual portion of the antibody that attaches to the noxious agent.
  • the units that make up the Y molecule are linked by disulfide bonds. These bonds are attacked in the intestines by papain and pepsin.
  • the "tail" of the Y molecule is sent through the digestive as any protein.
  • the VlVh is now a negatively charged.
  • the negative charged hypervariable segment peptide binds to positively charged areas on human globulin protein.
  • the human globulin carries the antibodies to the target organ. When the specific amino acid sequence portion of the v finds its complement, it locks into the receptor of the noxious agent and neutralizes it. If attached to the patient's globulin, the complex may activate a complement.
  • the complement causes monocytes to adhere to the compound and phagocytosis occurs.
  • the large peptides of the VI Vh circulate carried by other proteins, such as alburnum. They bind to the target pathogen they were formed against and compromise adhesion to body tissues. If there is no adhesion, there is no disease and pathogen is cleared from the body.
  • adhesian to the host is an important factor of primary virulence.
  • a variety of adhesive structures, broadly referred to as adhesions or lectans, on the surfaces of microorganisms serve to bind them to complementary adhesive structures on the surfaces of host cells known as receptors. This is very specific and similar to a lock and key.
  • Some pathogenic organisms have also developed proteinaceous surface structures, such as the fimbriae, or pili, like E. coli and c. albicous. Such structures play a role in the interaction of the organism with the glycoprotein receptor of host cells.
  • Adhesion of the pili lectan to the host cell surfaces glycoprotein receptor or basement membranes serves as an essential first step in the pathogenesis of disease.
  • Antibody can be raised against certain portions of pathogenic organisms adhesans rather than the organisms in entirety.
  • an enteropathogenic organism e.g., the pilus in fimbriated bacteria such as E. coli, Cholera vibro, salmonella, gonococcus, H. flu, proteus mircobilis and actinomyces viscosus
  • the cell receptor is now known for the most part to be a glycoprotein or glycolipid, two types of complex carbohydrates in which sugars are linked to proteins and lipids, respectively. Several thousand such receptors have been found.
  • the adhesan of the pathogen is now known to be a lectin once thought to be found only in plants. They are found on the surface of pathogens strategically positioned to combine with very specific carbohydrate receptors of the susceptible cell.
  • Lectans can be identified on toxins, viruses, bacterium, fungus, cancer cells, and other molecules identified as causing disease. It has been shown that antibody could thus be effectively raised against analogous structures. Examples of such structures might include the "coat" of CMV virus, the "gpl20 " or "V 3 " loop of HIV virus, etc. Specifically, the V loop of the gpl20 portion of the protein coat of the HIV virus is the site which specifically combines with the CD4 receptor of the T-cell lymphocyte.
  • TNF neutralizes its ability to bind to and infect a T-cell. This will be supplemented with anti-TNF antibody. Neutralizing TNF will suppress HIV replication in that TNF turns on the replicating gene of the HIV virus. TNF also is a mediator of metabolic and physiologic changes associated with illness in general. These effects occur throughout the body and primarily in the lamina intestinal of the intestine which is a site remote to the intestinal lumen. Similarly, glycoprotein B is the lectin for CMV. CMV has an affinity for nerve tissue, especially the optic nerve. Prophylaxis is thus important for all immune suppressed individuals, especially transplant patients where 25% have evidence of the disease. Candida albicans has a fimbriae adhesan.
  • the lectin is located at the end of the structure.
  • Candida pharyngitis or esophagitis is painful but Candida septicemia is potentially lethal. It is common in immune suppressed populations and in diabetic patients. IgY raised against lectans of this pathogen will control local and systemic manifestations of this disease.
  • the techniques for immunization of a hen against selected antigens are well- known to those in the art. Briefly, immunization may be performed by inoculation with the antigen by any appropriate route such as subcutaneous, intraperitoneal, intramuscular, or intravenous injection, or oral administration.
  • the preferred method of immunization is by intramuscular injection, preferably subcutaneous on the neck.
  • a suitable adjuvant is administered in conjunction with the antigen to enhance the immunization.
  • An adjuvant useful for this purpose is a water-in-oil emulsion adjuvant such as complete Freund's adjuvant (CFA). It has been found that the use of a suitable adjuvant is highly effective in maintaining a high antibody titer in the eggs of an immunized hen for a prolonged period, thereby making it possible to produce the desired antibody-containing substance efficiently.
  • the dose of the antigen is determined depending on the type of the antigen and adjuvant and the administration route in such a manner that an immune status is induced in the hen without development of excessive antigen toxicity.
  • the hen becomes sensitive to the antigen, i.e., immunized against the antigen.
  • a specific antibody against the antigen is produced within the body of the hen, and an egg laid by the hen contains the specific antibody.
  • the presence and the titer level of the specific antibody against the antigen in the hen and in eggs of the hen can be confirmed by a number of methods known to those skilled in the art of immunological tests.
  • one or more boosters at an appropriate dose level may be administered in order to maintain a high antibody titer in the hen.
  • a suitable adjuvant may be used in conjunction with the antigen.
  • the interval between the initial immunization and the first booster administration and between individual booster administrations depends on the specific characteristics of the antigen and is preferably at least two weeks.
  • an egg laid by the hen is collected and, if necessary, stored until use.
  • a plurality of eggs laid by one or more hens which have been immunized against the same antibody are collected and processed together to produce the desired substance which contains the antibody.
  • the yolk is usually separated from the collected egg or eggs for use in the production of the desired antibody. These antibodies then can be digested in vitro and the peptides of the hypervariable segments used to neutralize targeted molecules.
  • Soaps or other cleaning agents which might disinfect deeper tissues of wounds of patients contaminated with organisms, such as, for example, anti staph, anti E. coli and anti C. deficeal, MRSA (methicillin resistant staph aureus major help problem when patients are moved between different health residencies).
  • MRSA methicillin resistant staph aureus major help problem when patients are moved between different health residencies.
  • Mouth washes which could be used by dental patients and practitioners to protect against transmission of HIY or help treat gum tissues affected by periodontal dieases.
  • T cells For example, one could be made to pull out T cells; if we made an anti CD4 antibody we could then give healthy CD4 cells to transplant patients. This would be good for leukemics or other patients who have been chemically devoid of T cells by immunosupressive therapy. This will cut hospitalization and costs.
  • h Tablets taken on trips to protect patients against travelers' diarrhea and diseases causing suppressive diseases, such as cholera and salmonella.
  • i As part of a nutritional formula given to patients in ICU or during recuperation of intestinal surgery as protection from systemic sporead from the digestive tract during period of reduced consumption.
  • j Can be highly purified non-antigenic pepetides to be given either by pill for those patients who can not take the volumes needed or IV in those patients which are not able to receive any nourishments any other way
  • mice challenged with LD 100% dose of LPS by intrapoeritoneal injection Twenty animals were in each group. The animals were fed either TNF IgY (produced as described in U.S. Pat. No. , cited above) orally or saline control by holding the animal upright and then using a specifically designed feeding syringe with a blunt end to adminster the solution into the stomach.
  • TNF IgY produced as described in U.S. Pat. No. , cited above

Abstract

Globalement, l'invention concerne l'utilisation de préparations d'anticorps à base d'oeuf pour le traitement de maladies touchant l'organisme entier, chez l'homme et chez d'autres mammifères. On obtient d'abord les anticorps IgY à partir d'oeufs d'une pondeuse domestique immunisée activement contre un ou plusieurs des organismes pathogènes considérés, par injection d'un immunogène contenant des déterminants immunogènes propres au déclenchement des anticorps. On administre ensuite oralement ces anticorps à un mammifère souffrant d'une maladie infectieuse touchant l'organisme, laquelle est provoquée ou accentuée par le ou lesdits organismes pathogènes. Il en résulte une immunisation passive pour les sujets à système immunitaire défaillant ou naïf. Il n'est pas nécessaire de séparer les anticorps du jaune d'oeuf, si bien que le traitement et l'administration sont pratiques et peu onéreux. Les anticorps à base de jaune d'oeuf provenant de poules immunisées contre des antigènes spécifiques sont efficaces pour lutter contre des agents toxiques de type viral, bactérien, fongique ou protozoaire et contre les toxines, les enzymes, les médiateurs inflammatoires, les prostaglandines, les leucotriènes, les thromboxines et autres molécules messagers, les sarcomes ou les carcinomes, non seulement dans l'intestin, mais encore dans les tissus éloignés de l'intestin. Le déterminant immunogène peut renfermer uniquement une partie spécifique de l'organisme pathogène, par exemple la boucle ou l'enveloppe d'un virus ou la fimbria d'une bactérie ciliée. L'efficacité du procédé est avérée dans le traitement du SIDA chez l'homme, le choc septique à médiation par facteur de nécrose tumorale (TNF) chez la souris, et dans l'abaissement du nombre des cellules somatiques chez les bovins laitiers.
PCT/US1997/017722 1996-10-02 1997-10-02 Administration orale d'anticorps a base de jaune d'oeuf de poule pour le traitement de maladies WO1998014209A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU47419/97A AU729502B2 (en) 1996-10-02 1997-10-02 Oral administration of chicken yolk antibodies to treat disease
EP97909921A EP0930891A4 (fr) 1996-10-02 1997-10-02 Administration orale d'anticorps a base de jaune d'oeuf de poule pour le traitement de maladies
CA002267421A CA2267421A1 (fr) 1996-10-02 1997-10-02 Administration orale d'anticorps a base de jaune d'oeuf de poule pour le traitement de maladies
JP10516847A JP2001501622A (ja) 1996-10-02 1997-10-02 病気を治療するための鶏卵黄抗体の経口投与
NZ335170A NZ335170A (en) 1996-10-02 1997-10-02 Oral administration of chicken yolk Ig-gamma antibodies to treat disease

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72440896A 1996-10-02 1996-10-02
US08/724,408 1996-10-02

Publications (1)

Publication Number Publication Date
WO1998014209A1 true WO1998014209A1 (fr) 1998-04-09

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PCT/US1997/017722 WO1998014209A1 (fr) 1996-10-02 1997-10-02 Administration orale d'anticorps a base de jaune d'oeuf de poule pour le traitement de maladies

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Country Link
EP (1) EP0930891A4 (fr)
JP (1) JP2001501622A (fr)
KR (1) KR20000048855A (fr)
AU (1) AU729502B2 (fr)
CA (1) CA2267421A1 (fr)
NZ (1) NZ335170A (fr)
WO (1) WO1998014209A1 (fr)

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EP1085906A1 (fr) * 1998-06-10 2001-03-28 Ophidian Pharmaceuticals, Inc. Anticorps anticytokiniques utilises en prevention et traitement de maladies intestinales inflammatoires
US6395273B1 (en) 1998-06-10 2002-05-28 Promega Corporation Prevention and treatment of inflammatory bowel disease
EP1225915A2 (fr) * 1999-10-28 2002-07-31 Ophidian Pharmaceuticals, Inc. Prevention et traitement de maladies auto-immunes par administration luminale d'anticorps polyclonaux
WO2002078742A2 (fr) * 2001-01-30 2002-10-10 The Lauridsen Group, Incorporated Procedes et compositions destines au traitement de dysfonctions immunitaires
WO2002078741A2 (fr) * 2001-01-30 2002-10-10 The Lauridsen Group, Incorporated Procedes et compositions destines a moduler le systeme immunitaire des animaux
KR100364198B1 (ko) * 2000-06-09 2002-12-12 영농조합법인다한 헬리코박터 파이로리에 대한 개선된 ｌｇＹ 생성의유도방법 및 이에 의해 제조된 계란
KR100392566B1 (ko) * 2001-11-13 2003-07-23 주식회사 에그 바이오택 여드름질환에 관한 프로피오니박테리움 아크네스, 스타필로코커스 에피더미디스, 대장균에 대한 항-혼합균 공유 복합특수면역단백질(IgY) 함유 계란생산 및 항-혼합균 공유 복합특수면역단백질(IgY) 제조방법
WO2003105873A1 (fr) * 2002-06-13 2003-12-24 株式会社 トーカイビケン Preparation sur mesure et procede de production de ladite preparation
KR20040005541A (ko) * 2002-07-10 2004-01-16 선우선영 여드름 원인물질에 대한 효과적인 여러형태의 복합특이난황항체의 생산법
KR20040005540A (ko) * 2002-07-10 2004-01-16 백반석 장염과 식중독의 원인물질에 대한 복합 특이 난황 항체의생산 방법
KR20040005539A (ko) * 2002-07-10 2004-01-16 백반석 이온수와 당을 이용한 계란 난황내의 수용성 특수면역단백질의 분리 및 제조
EP1476184A1 (fr) * 2001-12-28 2004-11-17 Camas, Incorporated Adherence d'immunogenes et sa methode d'elaboration et d'utilisation
WO2008025099A1 (fr) * 2006-08-31 2008-03-06 A.C.N. 135 493 391 Pty Ltd As Trustee For Conca Unit Trust Traitement et/ou prévention des affections médicales non infectieuses en utilisant des compositions contenant des anticorps
US7355092B2 (en) 1999-12-27 2008-04-08 Ronald Marquardt Genetic vaccines for the production of chicken egg-yolk antibodies against enterotoxigenic Escherichia coli and other pathogens
US7445782B2 (en) * 2001-03-15 2008-11-04 Valorisation-Recherche, Societe En Commandite Antibodies for preventing and treating attaching and effacing Escherichia coli (AEEC) associated diseases
US7494652B1 (en) * 1998-06-10 2009-02-24 Promega Corporation Treatment of sepsis
US7883703B2 (en) * 2003-11-14 2011-02-08 The Brigham And Women's Hospital, Inc. Methods of modulating immunity
US20130011410A1 (en) * 2011-07-07 2013-01-10 Amicus Biotech Inc. Egg White Antibodies for Prevention and Treatment of Specific Localized Intestinal Infections and Diseases Associated with a Pathogenic Organism or Molecule
CN106749650A (zh) * 2016-12-19 2017-05-31 姚善龙 抗感冒病毒及肺链菌、葡萄球菌复合IgY抗体制备方法及其应用
US9701735B2 (en) 2010-11-23 2017-07-11 Pantheryx, Inc. Compositions and methods for treatment in broad-spectrum, undifferentiated or mixed clinical applications
US9828419B2 (en) 2011-08-19 2017-11-28 Ostrich Pharma Kk Antibody and antibody-containing composition

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KR100489615B1 (ko) * 2002-01-30 2005-05-17 주식회사 단바이오텍 리스테리아 모노사이토제네스 감염의 예방 및 치료를 위한항체, 이를 포함하는 알 및 이들의 제조방법
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JP2007084495A (ja) * 2005-09-22 2007-04-05 Daikin Ind Ltd ウイルス感染細胞処理方法
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US8282928B2 (en) 2007-05-30 2012-10-09 The Governors Of The University Of Alberta Anti-gluten egg yolk antibodies for the treatment of celiac disease
KR102200721B1 (ko) * 2019-11-18 2021-01-13 (주)애드바이오텍 연어 리케차성 패혈증 예방 또는 치료용 난황항체의 제조방법
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EP1085906A4 (fr) * 1998-06-10 2002-02-06 Ophidian Pharm Inc Anticorps anticytokiniques utilises en prevention et traitement de maladies intestinales inflammatoires
US6395273B1 (en) 1998-06-10 2002-05-28 Promega Corporation Prevention and treatment of inflammatory bowel disease
US7261891B2 (en) 1998-06-10 2007-08-28 Promega Corporation Antibodies to cytokines in the prevention and treatment of inflammatory bowel disease
US7494652B1 (en) * 1998-06-10 2009-02-24 Promega Corporation Treatment of sepsis
EP2033658A1 (fr) * 1998-06-10 2009-03-11 Ophidian Pharmaceuticals, Inc. Anticorps aux cytokines pour la prévention et le traitement des maladies intestines inflammatoires
WO2000052055A1 (fr) * 1999-02-26 2000-09-08 Hartmut Kobilke ANTICORPS DE CLASSE IgY SPECIFIQUES DE JAUNES D'OEUFS, LEUR OBTENTION ET LEUR UTILISATION
EP1225915A4 (fr) * 1999-10-28 2004-06-16 Ophidian Pharm Inc Prevention et traitement de maladies auto-immunes par administration luminale d'anticorps polyclonaux
JP2003535033A (ja) * 1999-10-28 2003-11-25 オフィディアン ファーマシューティカルズ，インコーポレーテッド 腸管腔に投与されるポリクローナル抗体による自己免疫疾患の予防および治療
EP1949914A1 (fr) * 1999-10-28 2008-07-30 Promega Corporation Prévention et traitement d'une maladie auto-immune à l'aide d'anticorps polyclonaux administrés au niveau de la lumière
EP1225915A2 (fr) * 1999-10-28 2002-07-31 Ophidian Pharmaceuticals, Inc. Prevention et traitement de maladies auto-immunes par administration luminale d'anticorps polyclonaux
US7355092B2 (en) 1999-12-27 2008-04-08 Ronald Marquardt Genetic vaccines for the production of chicken egg-yolk antibodies against enterotoxigenic Escherichia coli and other pathogens
KR100364198B1 (ko) * 2000-06-09 2002-12-12 영농조합법인다한 헬리코박터 파이로리에 대한 개선된 ｌｇＹ 생성의유도방법 및 이에 의해 제조된 계란
WO2002078741A3 (fr) * 2001-01-30 2003-05-01 Lauridsen Group Inc Procedes et compositions destines a moduler le systeme immunitaire des animaux
WO2002078741A2 (fr) * 2001-01-30 2002-10-10 The Lauridsen Group, Incorporated Procedes et compositions destines a moduler le systeme immunitaire des animaux
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WO2002078742A3 (fr) * 2001-01-30 2003-03-13 Lauridsen Group Inc Procedes et compositions destines au traitement de dysfonctions immunitaires
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EP0930891A1 (fr) 1999-07-28
AU4741997A (en) 1998-04-24
AU729502B2 (en) 2001-02-01
KR20000048855A (ko) 2000-07-25
CA2267421A1 (fr) 1998-04-09
JP2001501622A (ja) 2001-02-06
NZ335170A (en) 2001-08-31
EP0930891A4 (fr) 2001-07-04

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