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Claims for Patent: 7,696,159

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Claims for Patent: 7,696,159

Title:Treatment for basal cell carcinoma
Abstract:The present invention provides a method of treating basal cell carcinoma in a subject. Generally, the method includes administering to the subject an amount of IRM compound effective for treating basal cell carcinoma in a treatment cycle that includes at least two consecutive days in which the IRM compound is administered and at least one day in which the IRM compound is not administered.
Inventor(s): Owens; Mary L. (Cottage Grove, MN), Fox; Terrance L. (Oakdale, MN), Ginkel; Angela M. (St. Paul, MN)
Assignee: Graceway Pharmaceuticals, LLC (Bristol, TN)
Application Number:12/008,961
Patent Claims: 1. A method of treating a patient diagnosed with superficial basal cell carcinoma for six weeks, the method comprising: applying an effective amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine (imiquimod) to a treatment area of the patient in accordance with a six-week treatment cycle for treating superficial basal cell carcinoma; wherein, the treatment area comprises a biopsy-confirmed superficial basal cell carcinoma lesion and about one centimeter of extramarginal skin that surrounds and extends beyond the lesion; wherein, the six-week treatment cycle comprises applying the imiquimod to the treatment area in accordance with a seven-day treatment regimen for six consecutive weeks; wherein, the seven-day treatment regimen comprises (a) applying the imiquimod to the treatment area once per day prior to sleeping hours for five consecutive days and (b) not applying the imiquimod to the treatment area for two consecutive days; and wherein, the imiquimod, once applied to the treatment area, is left on the treatment area for about 8 hours.

2. The method of claim 1, wherein the treatment area is located on the head.

3. The method of claim 1, wherein the treatment area is located on the neck.

4. The method of claim 1, wherein the treatment area is selected from the group consisting of the nose, eyelids, ears, medial canthus, nasolabial fold, scalp, lip, fingers, toes, genitals and sun exposed areas.

5. The method of claim 1, wherein the method further includes the step of: conducting a first follow-up visit at approximately 12 weeks post-treatment to assess the treatment site for clinical clearance.

6. The method of claim 5, wherein the method further includes the step of: excising the treatment area for histological evidence of superficial basal cell carcinoma.

7. The method of claim 1, further comprising assessing patient response to the six-week treatment cycle after the end of the six-week treatment cycle, wherein the six-week treatment cycle (a) is about at least as effective as other treatments with 5% imiquimod cream that require more frequent administrations or greater total dosages, and (b) provides a reduced incidence of treatment interruptions for one or more rest periods due to adverse reactions.

8. The method of claim 1, further comprising assessing patient response to the six-week treatment cycle after the end of the six-week treatment cycle, by measuring: a complete histological response of the patient; a composite complete response of the patient; or a local skin reaction rate of the patient; wherein a complete histological response rate of about 82% is achieved at about 12 weeks after the six-week treatment cycle, a composite complete response rate of about 75% is achieved at about 12 weeks after the six-week treatment cycle, or a local skin reaction rate is achieved as follows at about 12 weeks after the six-week treatment cycle: an erythema local skin reaction rate of about 88%; an erosion local skin reaction of about 36%; an ulceration local skin reaction of about 22%; or a scabbing local skin reaction of about 52%.

9. The method of claim 1, wherein the effective amount of imiquimod is about 0.001 mg/cm2 to about 100 mg/cm.sup.2.

10. The method of claim 1, wherein the effective amount of imiquimod is about 0.1 mg/cm2 to about 5 mg/cm.sup.2.

11. The method of claim 1, wherein the effective amount of imiquimod is about 0.5 mg/cm2 to about 2 mg/cm.sup.2.

12. The method of claim 1, wherein the effective amount of imiquimod is effective to reduce the size of the lesion.

13. The method of claim 1, wherein the effective amount of imiquimod is effective to limit the growth of the lesion.

14. The method of claim 1, wherein the effective amount of imiquimod is effective to slow the growth of the lesion.

15. The method of claim 1, wherein the effective amount of imiquimod is effective to reduce the number of lesions.

16. The method of anyone of claims 1-15, wherein said application step comprises: applying the imiquimod as an imiquimod cream to the treatment area, wherein the imiquimod cream contains imiquimod in an amount of about 5%.

17. The method of anyone of claims 1-15, wherein the imiquimod is a 5% imiquimod cream.

18. A method of treating a patient diagnosed with superficial basal cell carcinoma for six weeks, the method comprising: applying an effective amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine (imiquimod) to a treatment area of the patient in accordance with a six-week treatment cycle for treating superficial basal cell carcinoma; wherein, the treatment area comprises a biopsy-confirmed superficial basal cell carcinoma lesion and about one centimeter of extramarginal skin that surrounds and extends beyond the lesion; wherein, the six-week treatment cycle comprises applying the imiquimod to the treatment area in accordance with a seven-day treatment regimen for six consecutive weeks; wherein, the seven-day treatment regimen comprises (a) applying the imiquimod to the treatment area once per day prior to sleeping hours for five consecutive days and (b) not applying the imiquimod to the treatment area for two consecutive days; and wherein, the imiquimod, once applied to the treatment area, is left on the treatment area for about 8 hours, the method having a response rate for multiple subjects treated with the method of at least as high a percentage as a response rate for multiple subjects treated with a control method, the control method comprising administering to a subject an identical amount of imiquimod in a control cycle in which the identical amount of imiquimod is administered to a treatment area of a control patient in accordance with a six-week control cycle; wherein, the treatment area comprises a biopsy-confirmed superficial basal cell carcinoma lesion and about one centimeter of extramarginal skin that surrounds and extends beyond the lesion; wherein, the six-week control cycle comprises applying the imiquimod to the treatment area in accordance with a seven-day treatment regimen for six consecutive weeks; wherein, the seven-day treatment regimen comprises (a) applying the imiquimod to the treatment area once per day prior to sleeping hours daily; and wherein, the imiquimod, once applied to the treatment area, is left on the treatment area for about 8 hours.

19. The method of claim 18, the treatment method additionally having fewer treatment interruptions for one or more rest periods due to adverse reactions compared to the control method.

20. The method of claim 18, wherein the imiquimod comprises a 5% imiquimod cream.

21. The method of claim 18, wherein the response rate is measured after the end of treatment with the treatment method or the control method as a complete histological response.

22. The method of claim 21, wherein the complete histological response rate of the treatment method is about 82% at about 12 weeks after the six-week treatment cycle.

23. The method of claim 18, wherein the response rate is measured after the end of treatment with the treatment method or the control method as a composite response rate assessment of subjects having both (a) an elimination of clinical evidence of basal cell carcinoma, and (b) a complete histological response.

24. The method of claim 23, wherein the composite response rate of the treatment method is about 75% at about 12 weeks after the six-week treatment cycle.

25. The method of claim 18, wherein the response rate is measured after the end of treatment with the treatment method or the control method as a local skin reaction rate.

26. The method of claim 25, wherein the local skin reaction rate is at least as follows at about 12 weeks after the six-week treatment cycle: an erythema local skin reaction rate of 88%; an erosion local skin reaction rate of about 36%; an ulceration local skin reaction rate of about 22%; or a scabbing local skin reaction rate of about 52%.
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