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Claims for Patent: 8,735,375

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Claims for Patent: 8,735,375

Title:Therapeutic compositions
Abstract: Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.
Inventor(s): Brown; Marc Barry (Watford, GB), Crothers; Michael (Hillsborough, GB), Nazir; Tahir (Isleworth, GB)
Assignee: LEO Laboratories Limited (Dublin, IE)
Application Number:13/769,811
Patent Claims: 1. A method of treating skin cancer in a subject in need thereof, the method comprising topically administering a therapeutically effective amount of a pharmaceutical formulation of ingenol angelate to the skin of the subject, wherein the pharmaceutical formulation comprises ingenol angelate in an amount from about 0.001% to about 0.15% w/w, and wherein at least about 97.5% of the ingenol angelate is ingenol-3-angelate (isoform `b`) and the pharmaceutical formulation has a pH of less than 4.

2. The method of claim 1, wherein the pharmaceutical formulation has a pH of about 3.5 or less.

3. The method of claim 1, wherein the pharmaceutical formulation has a pH of about 3.0.

4. The method of claim 1, wherein the pharmaceutical formulation has a pH within the range of about 2.5 to less than 4.0.

5. The method of claim 1, wherein the skin cancer is a squamous cell carcinoma.

6. The method of claim 1, wherein the skin cancer is a basal cell carcinoma.

7. The method of claim 1, wherein the skin cancer is a malignant melanoma.

8. The method of claim 1, wherein the pharmaceutical formulation is a gel.

9. The method of claim 2, wherein the skin cancer is a squamous cell carcinoma.

10. The method of claim 2, wherein the skin cancer is a basal cell carcinoma.

11. The method of claim 2, wherein the skin cancer is a malignant melanoma.

12. The method of claim 2, wherein the pharmaceutical formulation is a gel.

13. A method of treating a cancerous skin condition in a subject in need thereof, the method comprising topically administering a therapeutically effective amount of a pharmaceutical formulation of ingenol angelate to a skin lesion of the subject selected from the group consisting of squamous cell carcinoma, basal cell carcinoma, malignant melanoma, and actinic keratosis, wherein the pharmaceutical formulation comprises ingenol angelate in an amount from about 0.001% to about 0.15% w/w, and wherein at least about 97.5% of the ingenol angelate is ingenol-3-angelate (isoform `b`) and the pharmaceutical formulation has a pH of less than 4.

14. The method of claim 13, wherein the pharmaceutical formulation has a pH of about 3.5 or less.

15. The method of claim 13, wherein the pharmaceutical formulation has a pH of about 3.0.

16. The method of claim 13, wherein the pharmaceutical formulation has a pH within the range of about 2.5 to less than 4.0.

17. The method of claim 13, wherein the cancerous skin condition is a squamous cell carcinoma.

18. The method of claim 13, wherein the cancerous skin condition is a basal cell carcinoma.

19. The method of claim 13, wherein the cancerous skin condition is a malignant melanoma.

20. The method of claim 13, wherein the pharmaceutical formulation is a gel.

21. The method of claim 14, wherein the cancerous skin condition is a squamous cell carcinoma.

22. The method of claim 14, wherein the cancerous skin condition is a basal cell carcinoma.

23. The method of claim 14, wherein the cancerous skin condition is a malignant melanoma.

24. The method of claim 14, wherein the pharmaceutical formulation is a gel.

25. The method of claim 13, wherein the cancerous skin condition is actinic keratosis.

26. The method of claim 14, wherein the cancerous skin condition is actinic keratosis.
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