Claims for Patent: 10,561,723

Summary for Patent: 10,561,723

Title:	Treatment and prevention of anal conditions
Abstract:	The invention relates to methods, compositions, and kits for treating a condition with an immune response modifier and a human papillomavirus (HPV) vaccine. Conditions treatable with the methods, kits and compositions include but are not limited to neoplasia, anal intraepithelial neoplasia, high-grade squamous intraepithelial neoplasia, dysplasia, anal dysplasia, dysplastic lesion, high-grade dysplastic lesion, condyloma, anal cancer, anal tumor, HPV infection, and any HPV-induced condition.
Inventor(s):	Scheibel; Steven Frederick (Palm Springs, CA)
Assignee:	Marbley; Theodore C. (Palm Springs, CA)
Application Number:	15/743,133
Patent Claims:	1. A method for treating a human papillomavirus (HPV)-associated neoplasia or a HPV-associated cancer in a subject, comprising: providing an immune response modifier and a human papillomavirus (HPV) vaccine; administering a first dose of the immune response modifier intra-anally, perianally, or intratumorally; administering a first dose the HPV vaccine to the subject; continuing to administer one or more doses of the immune response modifier intra-anally, perianally, or intratumorally; and administering one or more subsequent doses of the HPV vaccine perianally to the subject, thereby treating the HPV-associated neoplasia or a HPV-associated cancer in the subject, wherein the HPV-associated neoplasia or a HPV-associated cancer is selected from the group consisting of anal intraepithelial neoplasia, anal high-grade squamous intraepithelial neoplasia, anal dysplasia, anal cancer, anal tumor and combinations thereof. 2. The method of claim 1, wherein the subject is a human. 3. The method of claim 1, wherein the subject is a male human. 4. The method of claim 1, wherein the subject is a female human. 5. The method of claim 1, wherein the immune response modifier and the HPV vaccine are provided in one composition. 6. The method of claim 1, wherein the immune response modifier and the HPV vaccine are provided in separate compositions. 7. The method of claim 1, wherein the immune response modifier and the HPV vaccine are administered concurrently, sequentially, or alternatively. 8. The method of claim 1, wherein the immune response modifier and the HPV vaccine are administered according to different schedules. 9. The method of claim 1, wherein the immune response modifier is administered before, during or after administering the HPV vaccine. 10. The method of claim 1, wherein the immune response modifier is an immunostimulant. 11. The method of claim 1, wherein the immune response modifier is a local immunostimulant. 12. The method of claim 1, wherein the immune response modifier is a toll-like receptor 7 (TLR7) agonist. 13. The method of claim 1, wherein the immune response modifier is selected from the group consisting of: imiquimod, resiquimod, ANA975 (Isotorabine), ANA773, IPH-32XX, R848, CL097, 852A, CROI2015, GS-9620, PF-4878691, PF-4878691, and a combination thereof. 14. The method of claim 1, wherein the immune response modifier is administered intra-anally. 15. The method of claim 1, wherein the immune response modifier is administered at a dose of about 0.001-0.01, 0.01-0.1, 0.1-0.5, 0.5-5, 5-10, 10-20, 20-50, 50-100, 100-200, 200-300, 300-400, 400-500, 500-600, 600-700, 700-800, 800-900, or 900-1000 mg/kg. 16. The method of claim 1, wherein the immune response modifier is administered at a dose of about 0.001-0.01, 0.01-0.1, 0.1-0.5, 0.5-5, 5-10, 10-20, 20-50, 50-100, 100-200, 200-300, 300-400, 400-500, 500-600, 600-700, 700-800, 800-900, or 900-1000 mg/m.sup.2. 17. The method of claim 1, wherein the immune response modifier is administered at about 1-10, 10-20, 20-30, 30-40, 40-50, 50-60, 60-70, 70-80, 80-90, or 90-100 mg per dose. 18. The method of claim 1, wherein the immune response modifier is administered about 1-3 times per day, 1-7 times per week, 1-9 times per month, or 1-12 times per year. 19. The method of claim 1, wherein the immune response modifier is administered for about 1-10 days, 10-20 days, 20-30 days, 30-40 days, 40-50 days, 50-60 days, 60-70 days, 70-80 days, 80-90 days, 90-100 days, 1-6 months, 6-12 months, or 1-5 years. 20. The method of claim 1, wherein the HPV vaccine is a nonavalent HPV vaccine, bivalent HPV vaccine, quadrivalent HPV vaccine, or a combination thereof. 21. The method of claim 1, wherein the HPV vaccine is GARDASIL, GARDASIL 4, GARDASIL 9, or CERVARIX, or a combination thereof. 22. The method of claim 1, wherein the HPV vaccine is a vaccine protective against HPV 6, 11, 40, 42, 43, 44, 53, 54, 61, 72, 73, 81, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, or 68, or a combination thereof. 23. The method of claim 1, wherein the HPV vaccine is administered intramuscularly, or perianally, or a combination thereof. 24. The method of claim 1, wherein the HPV vaccine is administered at about 0.001-0.01, 0.01-0.1, 0.1-0.5, 0.5-5, 5-10, 10-20, 20-50, 50-100, 100-200, 200-300, 300-400, 400-500, 500-600, 600-700, 700-800, 800-900, or 900-1000 mg/kg. 25. The method of claim 1, wherein the HPV vaccine is administered at about 0.001-0.01, 0.01-0.1, 0.1-0.5, 0.5-5, 5-10, 10-20, 20-50, 50-100, 100-200, 200-300, 300-400, 400-500, 500-600, 600-700, 700-800, 800-900, or 900-1000 mg/m.sup.2. 26. The method of claim 1, wherein the HPV vaccine is administered about 1-3 times per day, 1-7 times per week, 1-9 times per month, or 1-12 times per year. 27. The method of claim 1, wherein the HPV vaccine is administered for about 1-10 days, 10-20 days, 20-30 days, 30-40 days, 40-50 days, 50-60 days, 60-70 days, 70-80 days, 80-90 days, 90-100 days, 1-6 months, 6-12 months, or 1-5 years. 28. The method of claim 1, wherein a first dose of the immune response modifier and the first dose of the HPV vaccine are administered concurrently. 29. The method of claim 1, wherein the immune response modifier is administered intra-anally. 30. The method of claim 1, wherein the immune response modifier is administered once every about two days. 31. The method of claim 1, wherein the immune response modifier is administered about three times per week. 32. The method of claim 1, wherein the first dose of the HPV vaccine is administered intramuscularly. 33. The method of claim 32, wherein a second dose of the HPV vaccine is administered perianally. 34. The method of claim 1, wherein the HPV vaccine is administered once every about three weeks. 35. The method of claim 1, wherein the immune response modifier and the HPV vaccine are administered for about 1-5, 5-10, 10-15, 15-20, 20-25, 25-30, 30-35, 35-40, 40-45, or 45-50 weeks. 36. A method for treating a human papillomavirus (HPV)-associated neoplasia or a HPV-associated cancer in a subject, comprising: administering an immune response modifier intra-anally, perianally, or intratumorally about three times a week; administering a first dose a HPV vaccine intramuscularly to the subject following a first dose of the immune response modifier; administering one or more subsequent doses of the HPV vaccine perianally to the subject about every 3 weeks, thereby treating the HPV-associated neoplasia or a HPV-associated cancer in the subject, wherein the HPV-associated neoplasia or a HPV-associated cancer is selected from the group consisting of anal intraepithelial neoplasia, anal high-grade squamous intraepithelial neoplasia, anal dysplasia, anal cancer, anal tumor and combinations thereof.

Details for Patent 10,561,723

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	GARDASIL	human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant	Injection	125126	June 08, 2006		2035-07-21
Glaxosmithkline Biologicals	CERVARIX	human papillomavirus bivalent (types 16 and 18) vaccine, recombinant	Injection	125259	October 16, 2009		2035-07-21
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	December 10, 2014		2035-07-21