WO1997011667A2 - Utilisation therapeutique de serums d'animaux, en particulier du cheval, pour le traitement du sida, du cancer et d'autres maladies virales et bacteriennes - Google Patents

Utilisation therapeutique de serums d'animaux, en particulier du cheval, pour le traitement du sida, du cancer et d'autres maladies virales et bacteriennes Download PDF

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Publication number
WO1997011667A2
WO1997011667A2 PCT/IB1996/001115 IB9601115W WO9711667A2 WO 1997011667 A2 WO1997011667 A2 WO 1997011667A2 IB 9601115 W IB9601115 W IB 9601115W WO 9711667 A2 WO9711667 A2 WO 9711667A2
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Prior art keywords
animal
cancer
disease
antiserum
cells
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PCT/IB1996/001115
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English (en)
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WO1997011667A3 (fr
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Samir Chachoua
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Samir Chachoua
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Priority to AU71431/96A priority Critical patent/AU7143196A/en
Priority to EP96932773A priority patent/EP0853486A4/fr
Publication of WO1997011667A2 publication Critical patent/WO1997011667A2/fr
Publication of WO1997011667A3 publication Critical patent/WO1997011667A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/145—Amines having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2)
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Definitions

  • the present invention is directed to novel uses of horse serum and other animal sera in the treatment, diagnosis and clinical management of viral and bacterial diseases including AIDS, cancer, and autoimmune diseases.
  • Prior art in the use of horse/animal serum in the treatment of cancer has some use as in the case of the Glover antitoxin where antiserum raised against a microorganism associated with cancer was used to treat cancer with minimal success.
  • HIV human immunodeficiency virus
  • Current therapies directed at the chemical, physical and biological aspects of this disease have failed for a variety of reasons.
  • HIV has a high mutation rate.
  • normal human immunological responses to HIV are currently ineffective, if not counterproductive. Further stimulation without some alteration in mechanism or function only promotes inappropriate responses.
  • major failures are all too common with all current broad spectrum immunological stimulation.
  • use of lymphokines in current vaccine therapy is aimed at the use of HIV or viral particles of the same.
  • effective antiviral therapies are lacking in current treatments as well as an ineffectiveness with existing antibiotics in the absence ol an effective immune response
  • the present invention is directed to the use of immune sera including horse serum and other animal sera in the treatment of AIDS, cancer and other opportunistic infections
  • immune sera including horse serum and other animal sera in the treatment of AIDS, cancer and other opportunistic infections
  • cancer and AIDS are used repeatedly throughout this disclosure as the targeted diseases or conditions This is not for illustration purposes onl> and is not intended to limit the scope of this invention
  • the immune sera may be unmodified as it is the inventor ' s contention that anti-disease activity may be inherent or may be elicited in response to a challenge
  • the serum may be further purified electrophoretically Electrophoresis, and any other system of selective separation, are used to carry out this invention in novel ways to isolate active components from virgin/unchallenged organisms
  • Mature organisms tend to have superior development of their immunological parameters However, this is often accompanied with a greater possibility of incompatible antigens and allergic or rejection phenomenon when applied to other host organisms
  • Another potential serum source is immature fetal and embryonic sera These sources possess inherent resistance or other useful anti-disease activity, but are not likely to be as specific or as developed as those of the mature organisms Benefits may include a decreased risk of allergic or rejection phenomenon when applied to other organisms and may confer non-specific rejuvenation effects
  • the present invention relates to cellular, intracellular extracellular phenomenon as applied to immunologic and other systems, where a beneficial or useful property may be conferred directly or indirectly from in vivo or in vitro source animal or other, the following discussion is limited to the use of horse serum It should be noted that this is done for convenience purposes only, and is not intended to limit the scope of the present invention
  • the present invention is based in part on the idea that antibodies as well as other factors present in horse serum may be of benefit in the diagnosis and therapy of a number of viral and bacte ⁇ al diseases
  • current treatment with human serum extract is restricted to IgG
  • acute infections are initially addressed by other immunoglobulins
  • Immune memory is usually achieved with the IgG immunoglobulin
  • IgG activity is optimal as a memory response after other modifications have taken place in the body following the initial infection, initial immunoglobulin cellular and other responses Immunoglobulins have been shown to carr> more than a simple action of attachment and neutralization of the offending antigens Communication and modification may be among the other functions
  • Restricting the therapeutic field to the IgG is at best narrow-minded
  • Other immunoglobulins may be superior at certain immunological responses
  • a shark ' s resistance to cancer may be related to its specific serological immunity
  • Purification techniques refer both to the testing of serum sources and content for allergens, pathogens and pyrogens by standard laboratorv procedure as well as the further purification of product to minimize anti-human component (or component against whatever species to be treated)
  • the present invention does not solely relate to humans and human disease but applies wherever the host of a particular disease is unable to repel a disease as well as an outside source of the same or other specie when the disease is presented in the same or altered format
  • the present invention is further related to the idea of tagging and targeting where disease appearance may be altered so that the tagging component is then attacked by antiserum (see section on transfer factor and antiserum to primary, secondary and latter manifestations of disease as well as regression anticipation in therapy)
  • Purification procedures to minimize allergic or other undesirable potentials range from the primitive precipitation of certain fractions of serum by simple storage in refrigeration over 6 months at 3 degrees celsius
  • Serum solution from any animal is vaccinated against any single or mixture of diseases, for example, cancer, AIDS, he ⁇ es, leukemia, etc can pool multiple diseases or animal sources 20-30cc of serum solution added to 800-900 ml of saline B Heat at 55°C Add 15ml of 2% NaOH and heat an additional 30 minutes Add 10ml of 5% HCL and filter through number 1 filter paper, use gravity or negative pressure. 0 45 micron will probably do Add 1200 ml of saline A Add 30ml of 10% ammonium carbonate and boil on a hot plate Boil the serum solution once daily for three days The serum should be sealed to avoid evaporation and microbiological contamination 450ml of serum solution needed for process STEP 3-
  • the present invention provides some basic new methods and all modifications
  • An animal such as a horse can be injected with disease- causing and/or synergistic and/or promoting organisms and factors
  • Cells, serum and other physical, chemical and biological factors can be observed for changes which assist in the organism's rejection of the offending agent, for example, temperature immunological pH changes, etc
  • changes can then be used or duplicated in whole part, in an extract derivative or product thereof
  • RNA, protein, enzymes, carbohydrates, lipids, organelles, chemical, immunoglobulin changes or changes in the cell tissues or structures which produce them our examples will be confined for discussion purposes only to animal sera, particularly that of the horse Testing of pooled serum is used to identify the serum fractions with specific anti-disease activ
  • One way is to expose a test sample of pooled or other serum to the disease or antigen that is to be targeted After exposure, the serum electrophoretic or other spectrum is compared to the unexposed sample
  • the fractions that are missing or diminished are the serum disease specific fractions (SDSFs) Isolating the SDSFs and then treating the patient with SDSF allows for increased efficacy and higher dosage of the specific fraction
  • Treatment with SDSF minimizes the risk of allergy, contamination or other side effects
  • Further purification and safety techniques involve exposing pooled serum to normal cell, tissue, etc antigens from patient and then removing the fraction which attaches to these components from the treatment fraction Similar isolation and
  • horse sera have been used as example in this invention, the present invention applies to many organisms whole, part, extract, product or derivative thereof immunological or other system whole, part, extract, product or derivative thereof
  • Horses and their sera are used to indicate that there are animals and sera with more efficient resistance to certain diseases which may be inherent or cultivated in animals by techniques that could not be done in humans for ethical and other consideration
  • Horses and many other animals and organisms appear to have inherent and/or inducible anti-disease activity which may be different (and thus beneficial) if not superior to human responses, or with abilities which may be augmented by in vivo or in vitro manipulation or altered by such means to develop beneficial diagnostic, clinical or therapeutic applications including compositions and methods/or producing same
  • Such products may be used to educate or modify human (or other) immune responses, e g . by transfer of genetic information, transfer factor, across interspecies or by other pathways of modification of other diseases or responses to disease Alternatively or simultaneously, direct anti-disease activity may be utilized
  • the essence of this invention is to use an exogenous system superior to endogenous responses either solely or in combination with the endogenous system, directly or by education of the endogenous system
  • An embodiment of this invention involves the use of horse serum in the treatment of AIDS
  • Animal sera have been used unsuccessfully in the past in the treatment of cancer, however, horse sera have been demonstrated to be effective in the treatment of various infections prior to the advent of antibiotics
  • This invention also covers the use of such sera and their application against any disease-related ⁇ nfect ⁇ on(s), direct, induced or modified, with or without interplay with other exogenous or endogenous system, direct anti-disease activity-direct, included, modified with or without interplay with other exogenous or endogenous systems against disease in normal or altered presentation
  • the latter point refers to a tagging concept which is covered later Tagging essentially distinguishes between the use of effective responses against disease or disease-related organisms or conditions and the use of immune or other responses aimed not against the disease but against factors which have been made to tag to it
  • This embodiment relates to any condition but it will be broadly exemplified in the treatment of AIDS as explained below
  • Polyphasic therapy increases the efficacy of any one modality, and polyvalent therapy allows for the combination of effective therapeutic agents to improve desired results and minimize dosages of therapeutic agents which may have toxicity, e g , AZT
  • Another advantage is a multiple step process for eliminating the targeted condition whereby step one is the tagging of that condition with antigenetically powerful and specific agents These may induce attach by a different immunological arm. perhaps more effective than the prior one and exhibiting more resistance Passive antisera/transfer factors and other agents may be raised against the tagging component. and/or the tagging complex with the targeted condition
  • An antiserum administered may further add to the antigenicity of the complex, and itself be viewed as a tagging agent, allowing for the repetition of the above steps
  • a sarcoma may develop on the outside of the carcinoma or a sarcomatous- like change, whereby the development of a fibroblast reaction occurs which restricts the carcinoma development Therefore, a sarcoma can be viewed as a response to a carcinoma and a carcinoma can be seen as a immunological response to a sarcoma This may explain why, if you inject an animal which has one with the other, you aggravate the animal's condition
  • TIL in animals such as a pig can easily be transplanted into a human without harmful or allergic responses
  • One mechanism for amplifying the amount of TILs in the human body is to extract out a biopsy of the patient ' s cancer and implant it into an animal That animal will attack the cancer with an antiserum which can be used, stored and purified The animal will attack the cancer with an antiserum which will be of special use if the antiserum also relates to the causative organism, or if the animal is also vaccined against the causative organism
  • the animal will produce a cellular response within hours of injection of the cancer, which is largely neutrophilic This cellular response can lead to cells which can cause massive tumor destruction but may have significant side effects
  • TILs TILs from the animal in the cancer can then be extracted and amplified
  • TILs TILs from the animal in the cancer can then be extracted and amplified
  • These cells will amplify to a much greater extent than ordinary human TILs because, in the animal, these cells should be at a very young stage of clonal exhaustion In other words the TILs are very far from being clonally exhausted as compared to the human TILs Therefore, implantation of a tumor into an animal will give us the systemic immunological response which can be used in the way of cells, serum transfer factors, or various types It will provide us extracts from Peyer ' s patches in the spleen, thymus and other organs which are distant to where the tumor has been implanted, but which have strong anti-cancer activity Transplantation of tissue may yield a localized fibroblast scarring tissue formation response, which is capable of enclosing the cancer TILs and other cells will also be present These may be used whole, transfer factors taken therefrom,
  • TILs isolated in this manner should be able to demonstrate strong anti-cancer activity and should be regenerable when needed
  • the transfer factor from these TIL's can also have strong activity in stimulating the human immune system TIL s, although near extinction, may have transfer factor overlap in activity with other lymphocytes so that different clones of cells can be recruited as TIL's
  • the farther down the evolutionar scale, the animal implanted with the human cancer is from the human, the more varied the immune response against the cancer and the greater the generation of a resistant transfer factor and transformation factor The chances are that the cells generated in answer to this cancer will not overlap with human cells
  • the primary response of the animal will deal with a cell type that is not generallv used in the fight against cancer
  • transfer factor taken in the early stages of tumor inoculation in several animals will yield transfer factor from neutrophils and this will in turn, stimulate neutrophi a against the cancer in the human
  • Prior art involves the isolation of TIL ' s from the tumor mass and its external in vitro amplification using interferon, interleukin and other agents
  • P ⁇ or art also involves implanting genetics of tumor necrosis factor, interferon. interleukin, etc into tumor cells in an attempt to stimulate the TILs
  • the prior art also involves the raising of TIL ' s from animal cancers and injecting them back into human beings
  • Prior art fails in that TIL's are assumed to be near the end of their clonal numbers or virtuallv clonally exhausted That is why the TILs cannot be amplified indefinitely That is why outside of the in vitro situation when re-implanted into the human TILs fail to further amplify and maintain a lasting effect
  • Prior art in taking TIL's from animal tumor models and using them to treat human cancers fails to recognize that there is a difference between the TIL attacking an animal cancer and anticipating that they will automatically attack a human cancer The difference here in the prior art is that it is
  • a tumor infiltrating B-cell or a tumor attacking B- cell from a bird will elicit antibody formation which is cancer specific
  • the inventor also adds the organism or the causative factor and elicits the raising of antiserum cellular responses, humoral responses, endocrine responses and transfer factor responses against the cause as well as the symptoms of the disease, the cells themselves
  • the animal responses are subjected to an intermediate stage, whereby they are incubated in vino with the human cancer so that the surviving human cancer cells can then be re- moculated into the animal
  • multiple generations of tumor anti-cancer specific cellular, humoral and other responses are. therefore, elicited
  • the human cancer Upon treatment with the immune response from the animal, the human cancer will change in vivo and the dynamic format can be used and anticipated, whereby the resistance cells are repeatedly implanted into the animal to raise new clones of cells Cancer is therefore attacked immunologically by a range of specie responses which may be done simultaneously or in sequence to extend the duration of the administered therapy Cancer may be brought under fire from systems which are totally foreign in the anti-cancer defense mechanisms in the human, depending on how far removed the specie used to generate the response is from the human
  • a further object of this invention is to extract from the patient ' s blood his/her own private cells and treat them with the transfer factor raised in the animal and then re-infuse them with or without p ⁇ or amplification of the transfer factor into the host of the disease
  • Such therapy may be produced on an autogenous basis
  • accurate elimination of the disease may be made by tagging the disease with an agent against which an antiserum, a transfer factor, and a cellular response in the animal system has been raised and humanized so that the tagged disease can be anticipated, tagged, and then attacked with the anti-tag therapy previously raised
  • the transfer factor is administered prior to and the antiserum and cellular response can be administered post-tagging with tagging agents
  • organs and organisms which are resistent to certain diseases It is known that animals, such as the horse, have a superior immunological response against several diseases, particularly bacterial and viral infections A century ago, it was common to vaccinate a horse against a particular bacteria or virus in order to induce formation of an antiserum which, with minimal purification was then injected back into the patient The antiserum raised against human tissue whether it be healthy
  • horse serum can be used in its raw unpurified form or it can be purified in any number of ways so as to remove the anti-human component Resistance may be inherent or may be induced by vaccination of the animal
  • the present invention is directed to extensive purification techniques to yield the anti-disease fraction of the antiserum
  • One method involves the raising of an anti-human antiserum so that an animal of the same or other specie is vaccinated with normal human tissue and cellular components in order to raise a large titer of anti-human antiserum
  • the anti-human antiserum is then introduced into another animal in order to raise anti anti-human antiserum and when the disease fraction is vaccinated into a third animal prior to its use, it is treated with the anti anti- human antiserum in order to precipitate out the fraction of the antiserum which is directed against healthy cells, resulting in an
  • a simpler method is to take the resulting therapeutic agent, the antiserum or anti-human antiserum or anti-human cellular component and wash it against normal human red blood cells including the patient's normal cells, providing that these cells are not effected by the disease situation or antigenically marked by the disease
  • the therapeutic agent will lose the anti-serum against the normal human cells and will lose the cells against the normal human tissue and will be left only with a therapeutic agent in solution
  • Techniques may also be done whereby the disease agent is introduced into the therapeutic solution and by repeated washings, the anti-disease fraction with high affinity for the disease is removed This anti-disease fraction is then washed against normal human cells in order to remove any fraction of it with anti-normal human cell activity
  • the common laborator) techniques of washing against red blood cells and washing against the patient s own blood components and pyrogen assa> s were also combined with horse serum extraction to produce a novel method of therapy
  • horse serum is vaccined against the particular diseases including AIDS and Ebola virus
  • the horse, or any animal, once vaccinated against the AIDS virus, for example will yield a rise in the electrophoresis pattern relating to the area affected Peaks will appear that correlate to a possible pre-existing inherent resistent factor
  • animals which have never been exposed to the disease can still have that fragment ot their serum purified and raised to produce anti-disease activity with such a method there is virtually no risk of contaminating the animal serum p ⁇ or to treatment
  • Another way of assuring that the patient will not be contaminated with another persons organism or disease is to devote one animal per patient
  • Dynamic flow mechanism can easily be realized when a living system is donating the therapeutic agent
  • One of the major problems with producing an AIDS vaccine is that the AIDS virus repeatedly and rapidly mutates A living system donating the therapeutic agent can then be vaccined with the mutated agents so that a new anti-serum can be developed so that the line of therapy is never ending So long as the horse is alive, you can repeatedly vaccinate it with a new virus that is emerging This is dynamic flow mechanism of ensuring therapy is maintain for the particular patient
  • the purification process may be to the advantage of the patient for the treating cells and serum, etc
  • repeated “purification” presents some problems
  • an antiserum from a horse tags a diseased human cell which has been tagged, it provides a secondary tagging from the horses antigens themselves which are in proximity to the diseased cell It can induce a graft rejection phenomenon .
  • the transfer factor can be administered prior to any of the antiserum being given so that the bodv ' s old immune system can be "warned" and prepared for everything that will arise
  • the transfer factor may be a curative transfer factor, transformation transfer factor, transfer factor of resistance, etc against the new factors to arise
  • the antiserum raised from the horse and the transfer factor and the transformation factor raised from the disease condition with prior exposure to other agents creates a multivalent, multi-phasic therapy
  • primary horse serum may be raised against the disease
  • secondary horse serum may be raised against the appearance of the disease once the disease is treated with 2-MEA or an other agent, or AZT or whatever the agent You anticipate the changes caused either by the horse serum therapy itself and/or by other agents which may be used in parallel or in series with the horse serum Seeing the changes as the> happen and providing
  • ascites from a breast cancer patient would be expected to have the best effects against breast cancer
  • the inventor found that there is much cross reactivity between ascites fluid
  • the inventor further observed an optimal anti-breast cancer effect with prostate cancer fluid and vice versa
  • the ascites fluid appears to have more activity if it was bearing cancer cells at the time of implantation into animals
  • ascites fluids seem to have even more activity when it was obtained from a separate species It appeared that the effect was more than an immunologic effect Cancer masses from prostate cancer disappeared, masses of grapefruit size melted away within 6 to 12 hours without significant side effects
  • This remission is too fast for an immunologic reaction, however, if the cancers were varied and in type but belonged to broad categories such as carcinoma or sarcoma, and provided that they did not cross this category, because when the category was crossed and carcinoma was treated with sarcoma or vice versa occasionally improvement occurred but that was usually short lived and deterioration was usually rapid following So long as we stayed within the main headings it seemed that the more
  • One object of the invention is to identify and define human anti-serum extracted from ascites plural effusions and other bodily effusions which can best match and destroy cancer cells of different types
  • ascites effusions and plural effusions carry some factor which is strongly regenerative both in the immune stimulation and as an anti-cachectic agent
  • Anti-cachexia factors may be isolated from ascitic fluid and both fresh and old preparations of lysed cancer cells
  • Many of these anti-cachexia factors are filterable through a 0 2 micron filter, and may coincide with or also carry the function of pain-relieving and anti-inflammatory factors isolated from the same sources
  • Anti-cachexia factors prevented disastrous effects of weight loss and starvation in cancer patients
  • This also ties in with the theory that the cancer response is an anti-disease response in that dead cancer cell extracts injected into the patient from which they were removed, or into other patients, often resulted in weight gain, disappearance of pain, and shrinkage of tumor So it appears that cancer cells themselves possess an anti-
  • the present invention also includes pleural effusions, inflammatory effusions, as well as other bodily fluids and sera Ascites fluid was used from patients who had long term disease and appeared to be fighting it well, and was used largely in patients of similar disease
  • ascites fluid is superconcentrated and lyophilized so that the dosages of hundreds of mis can be obtained within lOcc and much higher doses can, therefore, be used
  • Ascites fluid is also not only raised in humans, but also in animals against not only the cancer but also the causative organism and also against tagged forms of the cancer
  • Ascites fluid from humans has the capacity of being able to attack and destroy cancer cells without causing any anti-human reaction It is an agent which is freely available and disposed of in thousands of liters every day in hospitals around the world
  • One of the novel points in the present invention is to lyophihze the fluid crude and/or purify and then lyophihze the ascites fluid
  • a feature of the present invention is
  • ascites fluid Another important factor about ascites fluid is that the cells existing in the acidic fluid are unlike other cancer cells in the body It is either that, or one of the basic theories may be flawed A few years ago constant drainage was said to be so damaging on the heart and system in general that doctors developed what is called the ascites shunt, whereby a catheter was passed from the peritoneum into the right atnum of the heart Ascites fluid was pumped through the heart and out into the circulatory system so that the tension was minimized and so that the protein, instead of escaping to the peritoneum, stayed in the circulation to stop swelling effects and heart failure, circulatory failure, and respiratory failure
  • I e cancer spreads as single cells freely circulating in the bloodstream settling down in areas and growing would have been cancer metastases Yet with the shunt technique, it appears that no further metastases resulted in several cases
  • Another therapy used in the present invention is extraction of the single cells from ascites fluid, centrifugation of the cells, which are also washed and purified These single cells have been attacked by the body s antibodv response inherent to the ascites fluid These cells form an excellent basis for the formation of vaccines both against that type of cancer and other types Cells extracted from ascites fluid can be processed so that they do not seed in other animals Cells extracted from ascites fluid and injected into animals bearing tumors will not seed However, these cells can cause a localized response which can cause rapid and dramatic shrinkage of cancer
  • Prior art included injection of one person ' s cancer into someone else who was bearing cancer or grafting of one person's cancer into someone else who is bearing cancer An immunological response follows which destroys the transplanted cancer It was believed that the immune system would be so angered that some of this would have a cross over effect, and destroy some of the patient ' s primary cancer as well, so that one could use cancer against cancer This often occurred to some extent With ascites fluid injection and asci
  • Death sequence complexes also seem to have something in common with phages and plasmids from bacteria which are dying as they too carry out the same effect. Death sequence complexes in dying bacteria and other micro organisms can simply be defined as phages and plasmids carrying the death sequence. When the bacteria dies, these death sequences are released and cause the death of similar bacteria in the vicinity. These are the mammalian counterparts of the death sequence.
  • ascites fluid is purified.
  • Ascites fluid can also be used as a very broad spectrum, anti-inflammatory agent.
  • Ascites fluids and extracts of ascites cells added to normal human cell cause extension of the Hayflick limit and culture. Extracts of cytoplasm of cancer cells of ascites fluid and of ascites fluid cells cause significant extension of cell survival in some normal cell lines dependant on the continued supply of those factors. In other words, when this factor is removed from a healthy cell, the healthy cell returns to normal, lives a normal life span and then dies. But ascites fluid in cancer cytoplasmic extract can be used to extend the Hayflick limit.
  • the death sequence released by the Hayflick limit of normal cells can be immunized against or neutralized by cancer cell extracts in a passive way, whereby a constant supply of cancer cell extract can maintain a healthy system for a very long period of time (other mechanisms of neutralizing the death sequence accomplish the same.
  • ascites fluid in the treatment of cancer in accordance with the present invention is not only amplified to produce more concentrated sera, but multivalent sera from various types of cancer is produced to account for various antigen antibody responses Ascites fluid is purified One can also quantitate the particular fraction of the ascites fluid which has the anti-cancer activity More importantlv .
  • cancer cells as they exist in the acidic fluid may form excellent vaccines because ascites fluid is usually one of the terminal stages of cancer Therefore if someone has lung cancer in its initial stages and you vaccinate him with cells from lung cancer and ascites fluid, he is essentially vaccinated against his own terminal stage P ⁇ or art differs from the present invention in that now we can purify components farther, check farther for contaminates, concentrate further, and perform a much broader spectrum ascites fluid preparation
  • An ascites fluid screen can be performed, wherebv in the same way as with antibiograms, cancer cells are cultured in a petri dish or placed in culture bottles and different types of ascites fluid and combinations arc added from different diseases and different sources including different species to see which has the greater cancer cell destruction
  • Ascites fluid can also be combined with ascites fluid raised against the organism in animals, ascites fluid raised against the organism with the tagged cells in animals or in people, antibiotics against the organisms, anti-serum against the organisms, phages against the organisms
  • Rats bearing Morris TC-hepatitis showed survival after application of lOcc of human breast ascitic fluid intrape ⁇ oneally every second day Having the animal model enables us to raise ascitic fluid as tagging complexes and the cancer or targeted disease as it would appear after tagging, this yields ascitic fluid of greater efficacy in destroying a targeted condition.
  • Ascitic fluid extracted from humans treated with vaccines which tag cancers with microorganism extracts will be rich in antiserum against the tagged manifestation of the targeted condition
  • Organisms may be seen in many disease conditions including cardiovascular as well as acute and chronic degenerative diseases Whether the organisms isolated from AIDS or other diseases play a role in cause or simply synergize with the disease. Raising vaccines and antisera against them appear beneficial, even in absence of anti- HIV antisera in therapy Blood from AIDS patients can be lysed by physical/chemical/biological means as previously described Plating on blood agar and or inoculation into TSB as well as many other media may be used 500cc of TSB are inoculated and cultured for three days Bacterial growth is centrifuged and resuspended in 30cc of normal saline Suspension is boiled for 15 minutes every three days then used to immunize an animal (horse) by injections intradermally of l cc every three days Animals can also be injected with living organisms or those prepared in vaccine format to anticipate a physical, chemical or biological therapy which the patient will undergo For example, targeted condition and/or associated organisms or factors
  • Targeted condition and/or associated organisms or factors may be irradiated and administered to the patient prior to the patient receiving radiotherapy
  • the vaccine response which may be further aided by various transfer factors will augment the other therapy by joining the therapy in its attack against the targeted condition and by providing an immunological modality for elimination of cells which are resistant to the other physical, chemical and biological therapies
  • Vaccines referred to above may be active (inducing host immunological response) or passive raisin antisera and other useful immunological fractions from outside the host Attenuation Factor
  • cancers in culture and in living systems have the capacity to attenuate many forms of microbial infections Although this capacity for production of attenuation factors is not unique to cancer cells, the attenuation factor in this invention may be isolated from other cell types
  • cancer cells appear to have an enormous propensity for attenuation of infectious agents in vivo and in vitro
  • leukemia cells infected with feline panleukopenia virus will be destroyed and the animal may appear in remission for a short period of time, usually measurable in weeks
  • vacuolation will still be seen in a significant percent of cells, suggesting that whereas the v irus initially cause vacuolation and extensive destruction, the virus is now incapable of destruction of the leukemia as previously
  • the virus appears to exist in synergy or a non-threatening manner in the cells
  • the virus appeared to be no longer as infective as initially This is evidenced b> a lower percentage of affected cells, suggesting a) higher cellular resistance, and b) viral attenuation Cell
  • Attenuation factor is evident as successive generations of infected cancer cells yield viruses of diminished ineffective capacity Attenuation factor exists m many cancer cell types and cancer-related fluids, and may be of assistance in placing viruses in a proviral state Ascitic fluid extracted from a patient with hepatoma who had been treated by tagging with various microbial factors and extracts showed greater than 99% inhibition of HIV cultured in vitro in human T-cell lives Other ascitic extracts have shown strong attenuation features in that, despite a rise in HIV yield, the T-cells remained largely unaffected In every animal species, there is an immunological response with great specificit and affinity In a diseased host, that response may be depleted TILs.
  • TILs isolated from animals bea ⁇ ng similar cancers and/or from animals inoculated or transplanted with the human cancer may be used to yield an effective cellular immune response which can be tolerated by the patient by any means of administration depending on the cancer and/or transfer factors isolated from the TILs against the disease and as it exists or as it may be anticipated or as it may appear tagged maj be of use
  • a transfer factor of resistance which is isolated from surviving animal or human cells exposed to certain conditions such as radiotherapy and chemotherapy, wherein the cells are normal cells of the diseased host being treated, surviving members can be used to yield transfer factors of resistance to augment and support similar cells in the host Cells which are damaged or killed by certain conditions such as the therapeutic modalities named above can be used to yield transfer factors of sensitivity These would be of use in specifically programming cancer cells to be more sensitive to therapy
  • Multimodal Therapy Multiphasic therapy may be used in synergistic multimodal approach That is to say that various modes may be used to augment each other's function Phages raised against or with activity against penicillin resistant organisms will augment the function of said antibiotic Function is even augmented against penicillin sensitive organisms
  • An example of this is the plating on blood agar of streptococcal culture with penicillin sensitivity Streptococcus was isolated from skin sample and possessed penicillin sensitivity (test was repeated on several occasions using penicillin as well as other types of antibiotics and streptococcal, staphylococcal and other host organisms as well as their phages as supplied by ATCC and/or raised independently, with similar results) after plating and culturing for 3 days at room temperature, the plate was covered with many purely streptococcal colonies On the third day, a disk saturated with procaine penicillin was placed in the center of the agar plate Within 24 hours a zone of clearance was evident around the disk as a halo measuring 2mm in depth The following
  • Multiphasic therapy in multiple modes can enhance each others function as well as offer prevention against the development of resistance
  • Phages can be raised specifically against antibiotic resistant strains of target organism Immune response such as antiserum, may be raised against organisms
  • Other techniques including selective filtration, electrophoresis and other technologies including isolation and genetic amplification technology including monoclonal antibody production and other mechanisms involving hybrid and other cell lines
  • the patent covers the use of anti sera/white blood cell extract/immunostimulation as adjunct to antibiotic therapy both directly and by raising response against target previously treated with antibiotic so that there is a passive as well as a latter active immune response against therapy resistant organisms It is possible to incubate patient cells with transfer factor from immunized cells of other source, to induce their activity against target organism, to recognize, isolate and amplify using interferon, interleukin and/or other modalities patient cells with activity against target
  • Table A below represents activity of animal sera, ascitic fluid, phages. attenuation factors (not restricted to those derived from cancer cells), and other agents as prepared in accordance with the methods outlined in the present invention
  • Table B demonstrates the safety and non-toxicity against normal tissue of products of the present invention.
  • Antisera raised against the heat killed organisms as described above is combined with antisera raised against the living bacteria (same preparation technique without the heat killing after resuspension in saline) vaccination is intradermal 0 5cc three times a week for three weeks, followed by antiserum preparation as previously described Antisera raised against these organisms appear capable of maintaining immune status and at least preventing deterioration in the cases studied Patient age 42 diagnosed for three years T-cell count dropping 80- 100 points per month over past four months T- cell count 31 1 1 4 8 ratio 0 2 Patient was treated with antiserum (0 6ct intradermal three times a week) raised against organisms isolated from his blood as per previous discussion
  • T4/T8 ratio 0 3 Fatigue and rapidly decreasing T-cell count Readings taken over the previous months had shown a monthly drop in T-cell counts by 150-200 per month At presentation T- cell count total 350, T4/T8 ratio 0 8 Specific antiserum (raised against pooled aids blood treated with antihuman antiserum) 0 6cc were administered intradermally three times a week
  • T4/T8 ratio 0 4 Goat serum - 0 lcc injected intradermally Day 3 - T-cell count 90 T4/T8 ratio 0 3 Day 10 - T-cell count 210 T4/T8 ratio 0 6
  • the initial drop may be attributable to either the antihuman effect of animal blood and/or to the lysis of infected/diseased cells
  • Antihuman antiserum was raised against normal human blood Pooled blood from aids patients were treated with antihuman antiserum and incubated for three hours (l cc of antiserum to 10cc of aids blood) lcc of supernatant was used to vaccinate horse intradermally three times a week for three weeks l OOcc of animal blood were then drawn and serum separated and stored for nine months to allow for antihuman fragment separation
  • animal immune response such as that of a horse also includes in patent the use of cells and cellular components including transfer factor
  • Efficacy is amplified when antiserum is used as part of multiphasic/multimodal therapy and new pathways/mechanisms are also generated It is possible, for example to tag diseased cells with fractions and then vaccinate animals against either the tagging agent alone or against the tagging agent-disease complex This is of particular importance in the treatment of cancer but is mentioned here to cover the use of antisera bv this mechanism in aids

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Abstract

L'invention concerne de nouvelles utilisations de sérums d'animaux, en particulier du cheval, pour le traitement, le diagnostic et la gestion clinique du SIDA, de cancers et d'autres maladies virales et bactériennes.
PCT/IB1996/001115 1995-09-25 1996-09-25 Utilisation therapeutique de serums d'animaux, en particulier du cheval, pour le traitement du sida, du cancer et d'autres maladies virales et bacteriennes WO1997011667A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU71431/96A AU7143196A (en) 1995-09-25 1996-09-25 Therapeutic applications of animal sera including horse serum in the treatment of aids, cancer, and other viral and bacterial diseases
EP96932773A EP0853486A4 (fr) 1995-09-25 1996-09-25 Utilisation therapeutique de serums d'animaux, en particulier du cheval, pour le traitement du sida, du cancer et d'autres maladies virales et bacteriennes

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Application Number Priority Date Filing Date Title
US428195P 1995-09-25 1995-09-25
US60/004,281 1995-09-25

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WO1997011667A3 WO1997011667A3 (fr) 1997-06-12

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PCT/IB1996/001115 WO1997011667A2 (fr) 1995-09-25 1996-09-25 Utilisation therapeutique de serums d'animaux, en particulier du cheval, pour le traitement du sida, du cancer et d'autres maladies virales et bacteriennes
PCT/IB1996/001059 WO1997011666A2 (fr) 1995-09-25 1996-09-25 Utilisation de 2-mercaptoethanolamine (2-mea) et de composes aminothiols similaires, en combinaison avec du 3,5-diisopropyl-salicylate de cuivre (ii) et des composes similaires, pour le traitement et la prevention de differentes maladies

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KR20030077743A (ko) * 2002-03-26 2003-10-04 변현규 In½
WO2004024129A1 (fr) * 2002-09-10 2004-03-25 Samir Chachoua Therapie induisant une remission
US20110311557A1 (en) * 2009-02-11 2011-12-22 Martin Heath Bluth Reciprocal serum/plasma exchange for the treatment of cancer

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US5994409A (en) 1997-12-09 1999-11-30 U.S. Bioscience, Inc. Methods for treatment of neuro--and nephro--disorders and therapeutic toxicities using aminothiol compounds
US6384259B1 (en) 1998-11-16 2002-05-07 Medimmune Oncology, Inc. Stable amorphous amifostine compositions and dosage form
US7939109B1 (en) * 1999-10-04 2011-05-10 John Carter Method of treating neoplastic disease in a human or animal patient
US7927612B2 (en) 2000-01-19 2011-04-19 Baofa Yu Combinations and methods for treating neoplasms
US6811788B2 (en) 2000-01-19 2004-11-02 Baofa Yu Combinations and methods for treating neoplasms
US6506413B1 (en) * 2001-04-30 2003-01-14 Joseph C. Ramaekers Compositions for treating animal diseases and syndromes
US7053072B2 (en) 2001-05-11 2006-05-30 Medimmune Oncology, Inc. Methods for the administration of amifostine and related compounds
FR2825923B1 (fr) * 2001-06-15 2006-04-07 Oreal Inhibiteur de no-synthase et utilisations
US7629333B2 (en) 2002-03-29 2009-12-08 Medimmune, Llc Stable amorphous amifostine compositions and methods for the preparation and use of same
GB2398497A (en) * 2003-02-19 2004-08-25 Walcom Animal Science Composition for improving immunity of animals
US9125874B2 (en) 2007-11-30 2015-09-08 The Ramaekers Family Trust Administration of transfer factor for improving reproductive health
CN101138634A (zh) 2006-09-07 2008-03-12 于保法 用于治疗肿瘤的组合物
EP2278984A4 (fr) 2007-11-30 2013-02-27 Ramaekers Family Trust Compositions et procédés d'amélioration de la fertilité
US11110303B2 (en) 2014-11-26 2021-09-07 Baofa Yu Hapten-enhanced chemoimmunotherapy by ultra-minimum incision personalized intratumoral chemoimmunotherapy

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20030077743A (ko) * 2002-03-26 2003-10-04 변현규 In½
WO2004024129A1 (fr) * 2002-09-10 2004-03-25 Samir Chachoua Therapie induisant une remission
US20110311557A1 (en) * 2009-02-11 2011-12-22 Martin Heath Bluth Reciprocal serum/plasma exchange for the treatment of cancer

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EP0853486A2 (fr) 1998-07-22
AU6999096A (en) 1997-04-17
EP0858327A2 (fr) 1998-08-19
WO1997011667A3 (fr) 1997-06-12
EP0853486A4 (fr) 2001-09-26
CA2233445A1 (fr) 1997-04-03
WO1997011666A3 (fr) 1997-06-19
JPH11514990A (ja) 1999-12-21
AU7143196A (en) 1997-04-17
CA2233015A1 (fr) 1997-04-03
WO1997011666A2 (fr) 1997-04-03

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