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Last Updated: January 26, 2022

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Claims for Patent: 9,795,575

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Summary for Patent: 9,795,575
Title:Compounds for use in treatment of mucositis
Abstract: The present invention provides methods for treating and/or preventing mucositis with one or more compounds, or pharmaceutically acceptable salts thereof, disclosed herein, or compositions comprising the same.
Inventor(s): Scott; Richard W. (Radnor, PA), Korczak; Bozena (Wayne, PA)
Assignee: Innovation Pharmaceuticals Inc. (Beverly, MA)
Application Number:15/239,460
Patent Claims:1. A method of treating mucositis in a mammal comprising administering to the mammal in need thereof a therapeutically effective amount of a compound of Formula X: ##STR00549## or a pharmaceutically acceptable salt thereof, wherein: G is ##STR00550## each X is, independently, O or S; each R.sup.1 is, independently, ##STR00551## or the free base or salt form of --(CH.sub.2).sub.n--NH.sub.2 or --(CH.sub.2).sub.n--NH--C(.dbd.NH)NH.sub.2, where each n is, independently, 1 to 4; each R.sup.2 is, independently, H, C.sub.1-C.sub.8alkyl, or the free base or salt form of --(CH.sub.2).sub.n--NH.sub.2 or --(CH.sub.2).sub.n--NH--C(.dbd.NH)NH.sub.2, where each n is, independently, 1 to 4; each R.sup.3 is, independently, H, CF.sub.3, C(CH.sub.3).sub.3, halo, or OH; and each R.sup.4 is, independently, --(CH.sub.2).sub.n--NH.sub.2 or --(CH.sub.2).sub.n--NH--C(.dbd.NH)NH.sub.2, where each n is, independently, 1 to 4.

2. The method of claim 1 wherein each R.sup.3 is, independently, CF.sub.3, C(CH.sub.3).sub.3, or halo.

3. The method of claim 2 wherein each R.sup.3 is CF.sub.3.

4. The method of claim 1 wherein each R.sup.4 is, independently, --(CH.sub.2).sub.n--NH--C(.dbd.NH)NH.sub.2, where each n is, independently, 1 to 4.

5. The method of claim 4 wherein each R.sup.4 is --(CH.sub.2).sub.n--NH--C(.dbd.NH)NH.sub.2, where each n is 4.

6. The method of claim 1 wherein G is ##STR00552##

7. The method of claim 1 wherein: G is ##STR00553## each X is, independently, O or S; each R.sup.1 is ##STR00554## each R.sup.3 is, independently, H or CF.sub.3; and each R.sup.4 is, independently, --(CH.sub.2).sub.n--NH.sub.2 or --(CH.sub.2).sub.n--NH--C(.dbd.NH)NH.sub.2, where each n is, independently, 1 to 4.

8. The method of claim 7 wherein the compound of Formula X is ##STR00555## or a pharmaceutically acceptable salt thereof.

9. The method of claim 1 wherein the mammal is a human.

10. The method of claim 9 wherein the human is administered a pharmaceutical composition comprising the compound, or pharmaceutically acceptable salt thereof.

11. The method of claim 10 wherein the pharmaceutical composition further comprises another therapeutic agent.

12. The method of claim 11 wherein the another therapeutic agent is palifermin.

13. The method of claim 9 wherein the human also receives chemotherapy, radiation therapy, or both, for treatment of cancer.

14. The method of claim 9 wherein the human also receives high-dose chemotherapy prior to hematopoietic cell transplantation, radiation therapy for tumors of the head and neck, induction therapy for leukemia, or conditioning regimens for bone marrow transplant.

15. The method of claim 10 wherein the pharmaceutical composition is administered orally, bucally, or sublingually.

16. The method of claim 10 wherein the pharmaceutical composition is a liquid.

17. The method of claim 10 wherein the pharmaceutical composition is a rinse.

18. The method of claim 17 wherein the compound in the rinse is at 1 mg/ml, 3 mg/ml, or 10 mg/ml.

19. A method of treating mucositis in a human comprising administering orally, bucally, or sublingually to the human in need thereof a liquid pharmaceutical composition comprising 1 mg/ml of a compound having the formula ##STR00556## or a pharmaceutically acceptable salt thereof.

20. A pharmaceutical composition comprising ##STR00557## or a pharmaceutically acceptable salt thereof, and palifermin.

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