Classifications

• • 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
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/0005—Vertebrate antigens
  • A61K39/0011—Cancer antigens
  • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P35/00—Antineoplastic agents
  • A61P35/02—Antineoplastic agents specific for leukemia
• • 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
  • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
• • 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
  • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
  • A61K2039/55505—Inorganic adjuvants
• • 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
  • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
  • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response

Definitions

• the immunogen is provided in an initial administration to the individual, thereby forming a response that includes IgM production.
• the present invention provides an alternative and or improved treatment regime for the reason that endogenous immune components such as antibodies and antigen specific cells that arise from immunisation have a longer and greater exposure to cell surface P2X 7 receptors, after the administration of antigen binding sites has been completed and the circulating level of non self anti-P2X 7 antigen binding sites has become undetectable.
• a “non self molecule, such as a "non self antigen binding site, or "non self antibody generally refers to a molecule that has been produced outside of, or exogenous to, a body in which the molecule is to be provided, for example, for treatment.
• synthetic or recombinant molecules are "non self.
• a molecule that is generated in one individual and administered to another individual for treatment is “non self.
• Non self antigen binding sites and antibodies may be used in accordance with the invention for adoptive transfer of immunity, for example, as occurs in antibody infusion.
• a molecule that is generated inside an individual that is to be treated with that molecule is generally a "self or "endogenous” molecule.
• One example of a "self molecule is an antigen binding site or antibody that is generated, or arises from an adaptive immune response to immunogen.
• the individual may have received immunotherapy leading to undetectable tumour mass and no longer has detectable circulating exogenous antibody at the time of immunisation.
• the individual selected for treatment according to a method described above may or may not have detectable cancer at the time of treatment. Where the individual does not have detectable cancer, a primary or secondary humoral response is more easily detected because, with the cancer being present in substantially undetected amount, there is very little non- functional P2X 7 receptor available to remove IgM or IgG from body fluid. This point is demonstrated in Figures 1 and 2.
• the antibody immunotherapy is allowed to continue to the desired clinical endpoint.
• the desired clinical endpoint is a reduction of cancer to substantially undetectable levels.
• the capacity of the individual to form, or generate an immune response to a P2X 7 receptor is then assessed. Where the assessment reveals that the individual is likely to benefit from immunisation with P2X 7 immunogen, the individual is then administered with immunogen.
• the antigen binding site may take the form of a whole antibody, or a whole antibody fragment such as a Fab, a Fab', a F(ab') 2 , and Fv, a single chain Fv, or a single variable domain.
• the antibody fragment is selected from the group consisting of a dAb, Fab, Fd, Fv, F(ab')2, scFv and CDR.
• the proper fluidity can be maintained, for example, by the use of a coating such as lecithin, by the maintenance of the required particle size in the case of dispersion and by the use of surfactants.
• a coating such as lecithin
• surfactants Suitable formulations for use in the therapeutic methods disclosed herein are described in Remington's Pharmaceutical Sciences, Mack Publishing Co., 16th ed. (1980).
• Prevention of the action of microorganisms can be achieved by various antibacterial and antifungal agents, for example, parabens, chlorobutanol, phenol, ascorbic acid, thimerosal and the like.
• isotonic agents for example, sugars, polyalcohols, such as mannitol, sorbitol, or sodium chloride in the composition.
• Prolonged absorption of the injectable compositions can be brought about by including in the composition an agent which delays absorption, for example, aluminum monostearate and gelatin.
• sterile injectable solutions can be prepared by incorporating an active compound (e.g., antigen binding site) in the required amount in an appropriate solvent with one or a combination of ingredients enumerated herein, as required, followed by filtered sterilization.
• an active compound e.g., antigen binding site
• dispersions are prepared by incorporating the active compound into a sterile vehicle, which contains a basic dispersion medium and the required other ingredients from those enumerated above.
• the preferred methods of preparation are vacuum drying, freeze-drying and spray drying, which yields a powder of an active ingredient plus any additional desired ingredient from a previously sterile-filtered solution thereof.
• the level of antibody formed from the humoral response may be at the higher end of this range, although in certain embodiments, in these circumstances, an amount of about 5mg/kg antibody may be sufficient. Further testing of immunity over the following months/years may be performed and boosting immunisations may be provided as required.
• a peptide immunogen for use in a method of the invention herein may have a length of 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 ,17, 18, 19, 20, 21, 22, 23, 24, 25 or 26 residues.
• Patent 5,500,161), Q57, saponins e.g., QS21, Ghochikyan et al., Vaccine, 24:2275, 2006
• saponins e.g., QS21, Ghochikyan et al., Vaccine, 24:2275, 2006
• squalene tetrachlorodecaoxide
• CPG 7909 Poly[di(carboxylatophenoxy)phosphazene]
• PCCP Payne et al., Vaccine, 16:92, 1998)
• interferon- ⁇ Cao et al., Vaccine, 10:238, 1992
• block copolymer P1205 CL1005; Katz et al., Vaccine,.
• the immunisation schedule consisted of a primary inoculation (two injections subcutaneously and two injections intramuscularly) of a total of 0.5 mg peptide followed a month later with a boost applied the same way with 0.3 mg peptide. Serum samples were collected immediately prior to and a week post injections. Inoculation is ideally administered no less than a month after the final infusion of anti-nfP2X 7 antibody to ensure no sequestration of the immunogen by residual specific anti-nfP2X 7 antibody infusate.

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• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Hematology (AREA)
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• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Medicines Containing Plant Substances (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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• 2012
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