Claims for Patent: 5,496,554

Summary for Patent: 5,496,554

Title:	Purified mite allergen
Abstract:	New purified mite allergens useful as pharmaceutical and diagnostic compositions for the treatment and diagnosis of mite allergic diseases are provided. Both allergens are contained in fecal extracts of mites in culture. The high molecular weight allergen has a weight average molecular weight of 70,000 to 80,000 as determined by sedimentation equilibrium. This is a glycoprotein containing more than about 70% sugar, and possesses allergen activity. The low molecular weight antigen has a molecular weight of 1,500 to 5,000 as determined by Sephadex G25 gel filtration. This is a glycoprotein containing more than about 40% sugar, and also possesses allergen activity.
Inventor(s):	Oka; Satoru (Hiroshima, JP), Ono; Kazuhisa (Hiroshima, JP), Shigeta; Seiko (Hiroshima, JP), Wada; Takeshi (Hiroshima, JP)
Assignee:	Fumakilla Limited (Tokyo, JP) Hiroshima University (Hiroshima, JP)
Application Number:	08/283,905
Patent Claims:	1. A purified and isolated mite allergen, said allergen possessing the following physicochemical and biological properties: 1 being isolated and purified from fecal extracts of mites in cultures; 2 being a glycoprotein containing more than 70% sugar; 3 having a weight-average molecular weight of 70,000 to 80,000 as determined by sedimentation equilibrium; 4 possessing allergen activity; and 5 being unstainable by Coomassie blue. 2. The purified and isolated mite allergen according to claim 1, wherein said allergen: is freely soluble in water; has a weight-average molecular weight of about 74,000; has a specific volume of 0.6076; has a sugar content of 77%; has the amino acid composition and sugar composition shown in Table 5; and possesses allergen activity. 3. The purified mite allergen according to claim 1, wherein said mite is Dermatophagoides pteronyssinus or Dermatophagoides farinae. 4. The purified and isolated mite allergen according to claim 1, which has the amino acid composition and sugar composition shown in Table 5. 5. A pharmaceutical composition for the treatment of mite allergic diseases, comprising as the active ingredient a pharmaceutically effective amount of the purified and isolated mite allergen according to claims 1, 3, or 4, and at least one pharmaceutically acceptable carrier or diluent. 6. A method of diagnosing mite allergic disease, comprising assaying the amount of histamine released from the basophils in a sample of a patient's blood in response to stimulation by the purified and isolated mite allergen according to claims 1, 3, or 4. 7. The method according to claim 6, wherein said method is hyposensitization therapy. 8. The method according to claim 7, wherein said mite allergen is used in formulation with an adjuvant and at least one additive selected from the group consisting of a stabilizer, an excipient, a dissolution aid, an emulsifier, a buffer, an analgesic, a preservative, and a colorant. 9. The method according to claim 7, wherein said mite allergen is administered intracutaneously, subcutaneously, intramuscularly, or intraperitoneally. 10. The method according to claim 7, wherein said mite allergen is used in the form of a troche, a sublingual tablet, an ophthalmic solution, an intranasal spray, a poultice, a cream, or a lotion. 11. The method according to claim 7, wherein said mite allergen is administered in an amount of less than about 20 .mu.g once per week. 12. A method of treatment for mite allergic diseases, comprising administering a pharmaceutically effective amount of the purified and isolated mite allergen according to claims 1, 3, or 4. 13. A diagnostic composition for mite allergic diseases, comprising as the active ingredient a diagnostically effective amount of the purified and isolated mite allergen according to claims 1, 3, or 4.

Details for Patent 5,496,554

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Greer Laboratories, Inc.	N/A	insects (whole body), mite dermatophagoides farinae	Injection	101834	09/15/1958		2013-03-05
Greer Laboratories, Inc.	N/A	insects (whole body), mite dermatophagoides pteronyssinus	Injection	101835	09/15/1958		2013-03-05
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2013-03-05