Claims for Patent: 5,026,545

Summary for Patent: 5,026,545

Title:	Treatment of allergy and composition therefor
Abstract:	A pharmaceutical composition comprises an immune complex of an allergen and a purified antibody specific thereto, the allergen being selected from a specific subclass of antigen which causes immediate hypersensitivity that is mediated by IgE antibody, and a pharmacologically acceptable carrier or diluent. The method of using the compositions in the treatment of immediate hypersensitivity to the allergen is also described.
Inventor(s):	Saint-Remy; Jean-Marie (Grez-Doiceau, BE), Lebrun; Philippe (Namur, BE), Lebeque; Serge (Brussels, BE), Masson; Pierre L. (Brussels, BE)
Assignee:	Baxter International, Inc. (Deerfield, IL) International Institute of Cellular and Molecular Pathology (Brussels, BE)
Application Number:	07/410,021
Patent Claims:	1. A pharmaceutical composition for administration to human beings for the treatment of immediate hypersensitivity to an allergen, said composition consisting essentially of: an immune complex of the allergen and a purified antibody specific thereto, said allergen being selected from a specific subclass of antigen that can cause immediate hypersensitivity that is mediated by IgE antibody, said antibody being present in said composition in a molar excess with respect to said allergen present in said composition; and a pharmacologically acceptable carrier or diluent. 2. The composition of claim 1, further comprising a mixture of said allergen and said antibody of which said complex is a part, the antibody of said mixture being present in said molar excess with respect to said allergen of said mixture. 3. The composition of claim 1, wherein said antibody of said complex is present in said molar excess with respect to said allergen of said complex. 4. The composition of claim 1, wherein the amount of antibody is such that, when the composition is administered, there is no significant allergenic effect. 5. The composition of claim 1, wherein the allergen to antibody molar ratio is from about 1:3 to about 1:30. 6. The composition of claim 1, wherein the allergen is present in a dose of from about 1.0.times.10.sup.-10 g to about 8.0.times.10.sup.-8 g. 7. The composition of claim 1, wherein said composition is in sterile injectable form. 8. The composition of claim 1, wherein said antibody is human-derived. 9. The composition of claim 8, wherein said antibody is derived from a patient suffering immediate hypersensitivity to the allergen. 10. The composition of claim 8, wherein said antibody is derived from pooled plasma from multiple donors. 11. The composition of claim 1, wherein said antibody is a polyclonal antibody. 12. The composition of claim 1, wherein said antibody is a mixture selected from the group consisting of monoclonal antibodies and fractions derived from monoclonal antibodies. 13. The composition of claim 12, wherein said antibody is in the form of F(ab').sub.2 fragments. 14. The composition of claim 1, wherein said antibody consists of a mixture of antibodies selected from isotypes of the group consisting of IgG, IgM, IgA, and IgE. 15. The composition of claim 14, wherein said antibody consists of a mixture of about 50% IgG antibody, about 35% IgM antibody, about 14.5% IgA antibody, and about 0.5% IgE antibody. 16. The composition of claim 1, wherein said composition comprises two or more allergens and two or more respective families of antibodies thereto. 17. The composition of claim 1, wherein said allergen is phospholipase A, and said antibody is a mixture selected from the group consisting of monoclonal antibodies against phospholipase A, and fractions derived from monoclonal antibodies. 18. A desensitization method for reducing the immediate hypersensitivity of a human being to an allergen, said allergen being selected from a specific subclass of antigen that can cause immediate hypersensitivity that is mediated by IgE antibody, said method comprising the steps of administering a composition comprising an immune complex of said allergen and antibody specific thereto to said human being, wherein the molar amount of antibody in said composition exceeds the amount of allergen in said composition such that there is no significant allergic effect by the allergen. 19. The method of claim 18, wherein said mixture is repeatedly administered, whereupon a dosage of allergen is gradually increased. 20. The method of claim 18, further comprising the step of deriving said antibody from a human source. 21. The method of claim 20, further comprising the step of deriving said antibody from said human being. 22. The method of claim 20, further comprising the step of deriving said antibody from a pooled plasma from multiple donors. 23. The method of claim 18, further comprising the step of genetically engineering said allergen. 24. The method of claim 18, further comprising the step of synthetically producing said allergen. 25. The method of claim 18, wherein said allergen is P1, a major allergen of Dermatophagoides pteronyssinus, the method further comprising the step of genetically engineering P1. 26. The method of claim 18, wherein said allergen is P1, a major allergen of Dermatophagoides pteronyssinus, the method further comprising the step of synthetically producing P1.

Details for Patent 5,026,545

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Greer Laboratories, Inc.	N/A	insects (whole body), mite dermatophagoides pteronyssinus	Injection	101835	09/15/1958		2040-01-28