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Last Updated: March 29, 2024

Claims for Patent: 9,808,438


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Summary for Patent: 9,808,438
Title:Method for treating mucositis
Abstract: The invention provides a pharmaceutical composition for preventing or treating mucositis, for example oral mucositis (e.g., oral ulceration) and gastrointestinal mucositis, comprising a monoacetyldiacylglycerol compound, especially PLAG, and a method of preventing or treating mucositis using the same.
Inventor(s): Sohn; Ki-Young (Seoul, KR)
Assignee: Enzychem Lifesciences Corporation (Seoul, KR)
Application Number:14/959,750
Patent Claims:1. A method for treating mucositis, comprising administering to a patient having mucositis a pharmaceutically effective amount of a compound of Formula 2: ##STR00007##

2. The method of claim 1 wherein the compound of Formula 2 is administered in a pharmaceutical composition which is substantially free of other monoacetyldiacylglycerol compounds.

3. The method of claim 1 wherein the compound of Formula 2 is administered in a pharmaceutical composition which is substantially free of other triglyceride compounds.

4. The method of claim 1 wherein the mucositis is oral mucositis or gastrointestinal mucositis.

5. The method of claim 4 wherein the mucositis is oral ulceration.

6. The method of claim 5 wherein the mucositis is recurrent oral ulceration.

7. The method of claim 6 wherein the recurrent oral ulceration is caused by a disease or condition selected from chemotherapy, irradiation therapy, neutropenic condition and autoimmune disease.

8. The method of claim 7 wherein the recurrent oral ulceration is caused by a disease selected from recurrent aphthous stomatitis (RAS), systemic lupus erythematosus (SLE) and Behcet's disease (BD).

9. The method of claim 1 wherein the mucositis is caused by an infection.

10. The method of claim 9 wherein the infection is herpes simplex virus (HSV) or candida infection.

11. The method of claim 1 wherein the mucositis is caused in whole or in part by radiation therapy.

12. The method of claim 1 wherein the mucositis is caused in whole or in part by chemotherapy.

13. The method of claim 12 wherein the mucositis is caused by a drug selected from Ziv-aflibercept, Brentuximab Vedotin, Deferiprone, Gemcitabine, Pralatrexate, Ganciclovir, Valganciclovir, Thalidomide, Romidepsin, Boceprevir, Decitabine, Imatinib, Topotecan, Lenalidomide, Paclitaxel, Olanzapine, Irinotecan, Paliperidone, Interferons, Lipopolysaccharide, Tamoxifen, Flecainide, Phenytoin, Indomethacin, Propylthiouracil, Carbimazole, Chlorpromazine, Trimethoprim/sulfamethoxazole (cotrimoxazole), Clozapine, Ticlodipine, and their derivatives, Cyclophosphamide, Mechlorethanime, Chlorambucil, Melphalan, Caunustine(BCNU), Lomustine(CCNU), Procarbazine, Dacarbazine(DTIC), Altretamine, Cisplatin, Carboplatin, Actinomycin D, Etoposide, Topotecan, Irinotecan, Doxorubicin & daunorubicin, 6-Mercaptopurine, 6-Thioguanine, Idarubicin, Epirubicin, Mitoxantrone, Azathioprine, 2-Chloro deoxyadenosine, Hydroxyurea, Methotrexate, 5-Fluorouracil, Cytosine arabinoside, Azacytidine, Fludarabine phosphate, Vincristine, Vinblastine, Vinorelbine, Paclitaxel, Docetaxel, Tamoxifen, Pemetrexed, Nab-paclitaxel, Dasatinib, Paralatrexate, Decitabine, Romidepsin, Lenalidomide, Sunitinib, Oxaliplatin, Adriamycin, Ifosfamide, Cytarabine and Thalidomide.

14. The method of claim 13 wherein the patient is intending to receive chemotherapy at a dose sufficient to cause mucositis in the absence of other treatment, or suffering from mucositis consequent to chemotherapy.

15. The method of claim 1 wherein the mucositis is associated with hematopoietic stem cell transplantation or peripheral stem cell infusion.

16. The method of claim 1 wherein the method further comprises administering to a patient in need thereof an effective amount of an additional agent sequentially or simultaneously.

17. The method of claim 16 wherein the additional agent is selected from the group consisting of Palifermin, Amifostine, Gelcair, Zilactin, IL-6 antagonists (e.g., anti-IL-6 antibodies) and a mixture thereof.

18. The method of claim 1 wherein the method further comprises low-level laser therapy (LLLT).

19. The method of claim 1 wherein the treatment is prophylactic.

20. The method of claim 1 wherein the compound of Formula 2 is administered in a pharmaceutical composition and the pharmaceutical composition may be formulated into solid, liquid, gel or suspension form for oral or non-oral administration.

21. The method of claim 20 wherein the compound of Formula 2 is administered in the form of a pharmaceutical composition for oral administration.

22. The method of claim 21 wherein the compound of Formula 2 is administered in the form of a pharmaceutical composition which is a soft gelatin capsule containing the compound of Formula 2 in combination or association with a pharmaceutically acceptable diluent or carrier.

23. The method of claim 22 wherein the total daily dosage of the compound of Formula 2 is 250 mg to 2000 mg/day.

24. The method of claim 23 wherein the composition further comprises a pharmaceutically acceptable antioxidant.

25. The method of claim 24 wherein the pharmaceutically acceptable antioxidant is selected from ascorbic acid (AA, E300), tocopherols (E306), propyl gallate (PG, E310), tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole (BHA, E320) and butylated hydroxytoluene (BHT, E321).

26. The method of claim 25 wherein the compound of Formula 2 is administered in the form of a soft gelatin capsule for oral administration containing 250-1000 mg of a compound of Formula 2, substantially free of other triglycerides, together with 0.1-3 mg of a pharmaceutically acceptable tocopherol compound.

27. The method of claim 26 wherein the compound of Formula 2 is administered in the form of a soft gelatin capsule for oral administration containing 250 mg or 500 mg of a compound of Formula 2, substantially free of other triglycerides, together with 1 mg of a pharmaceutically acceptable tocopherol compound, administered once or twice a day.

Details for Patent 9,808,438

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Swedish Orphan Biovitrum Ab (publ) KEPIVANCE palifermin For Injection 125103 12/15/2004 ⤷  Try a Trial 2039-02-26
Regeneron Pharmaceuticals, Inc. EYLEA aflibercept Injection 125387 11/18/2011 ⤷  Try a Trial 2039-02-26
Regeneron Pharmaceuticals, Inc. EYLEA aflibercept Injection 125387 08/16/2018 ⤷  Try a Trial 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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