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Last Updated: July 6, 2020

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Claims for Patent: 10,278,934

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Summary for Patent: 10,278,934
Title:Compositions and methods of use of phorbol esters in the treatment of neoplasms
Abstract: Methods and compositions containing a phorbol ester or a derivative of a phorbol ester are provided for the treatment of chronic and acute conditions. Such conditions may be caused by disease, be symptoms, treatments, or sequelae of disease. The phorbol esters described are particularly useful in the treatment of neoplastic diseases and/or managing the side effects of chemotherapeutic and radiotherapeutic treatments of neoplastic diseases.
Inventor(s): Han; Zheng Tao (Zhengzhou, CN), Chen; Hung-Fong (Taipei, TW)
Assignee: Biosuccess Biotech Co., Ltd. (San Jose, CA)
Application Number:15/938,182
Patent Claims:1. A method for inducing remission comprising administering to a mammalian subject with cancer selected from the group consisting of lymphoma, breast cancer, lung cancer, liver cancer, pancreatic cancer, nasopharyngeal cancer, cervical cancer, and multiple myeloma, an effective amount of a phorbol ester of Formula I, or a pharmaceutically-acceptable salt, isomer, or enantiomer thereof, ##STR00052## wherein R.sub.1 and R.sub.2 may be hydrogen; hydroxyl; ##STR00053## wherein the alkyl group contains 1 to 15 carbon atoms; ##STR00054## wherein a lower alkenyl group contains between 1 to 7 carbon atoms; ##STR00055## R.sub.3 may be hydrogen or ##STR00056## wherein said effective amount is between about 10 .mu.g to about 1500 .mu.g of said phorbol ester of Formula I is administered at least twice a week, and wherein the phorbol ester of Formula I is administered at least a total of 15 times.

2. The method of claim 1, wherein R.sub.1 or R.sub.2 is ##STR00057## the remaining R.sub.1 or R.sub.2 is ##STR00058## and R.sub.3 is hydrogen.

3. The method of claim 1, wherein the phorbol ester is phorbol 13-butyrate, phorbol 12-decanoate, phorbol 13-decanoate, phorbol 12,13-diacetate, phorbol 13,20-diacetate, phorbol 12,13-dibenzoate, phorbol 12,13-dibutyrate, phorbol 12,13-didecanoate, phorbol 12,13-dihexanoate, phorbol 12,13-dipropionate, phorbol 12-myristate, phorbol 13-myristate, phorbol 12,13,20-triacetate, 12-deoxyphorbol 13-angelate, 12-deoxyphorbol 13-angelate 20-acetate, 12-deoxyphorbol 13-isobutyrate, 12-deoxyphorbol 13-isobutyrate-20-acetate, 12-deoxyphorbol 13-phenylacetate, 12-deoxyphorbol 13-phenylacetate 20-acetate, 12-deoxyphorbol 13-tetradecanoate, phorbol 12-tigliate 13-decanoate, 12-deoxyphorbol 13-acetate, phorbol 12-acetate, or phorbol 13-acetate.

4. The method of claim 1, wherein the phorbol ester is 12--O-tetradecanoylphorbol-13-acetate.

5. The method of claim 1, wherein the phorbol ester of Formula I is administered parenterally.

6. The method of claim 1, wherein said phorbol ester of Formula I is administered at least 30 times.

7. The method of claim 1, wherein said effective amount is between about 100 .mu.g to about 300 .mu.g.

8. The method of claim 1, further comprising administering at least one secondary or adjunctive therapeutic agent to said subject in a coordinate administration protocol, simultaneously with, prior to, or after, administration of said phorbol ester to said subject.

9. The method of claim 1, wherein the at least one secondary or adjunctive therapeutic agent is selected from the group consisting of: doxorubicin, vitamin D3, cytarabine, cytosine arabinoside, daunorubicin, cyclophosphamide, gemtuzumab ozogamicin, idarubicin, mercaptopurine, mitoxantrone, thioguanine, aldesleukin, asparaginase, carboplatin, etoposide phosphate, fludarabine, methotrexate, etoposide, dexamethasone, and choline magnesium trisalicylate.

10. The method of claim 9, wherein two secondary or adjunctive therapeutic agents are administered to said subject.

11. The method of claim 10, wherein the two secondary or adjunctive therapeutic agents are dexamethasone and choline magnesium trisalicylate.

12. The method of claim 1, wherein the cancer is lung cancer.

13. The method of claim 1, wherein the cancer is lymphoma.

14. The method of claim 1, wherein the cancer is breast cancer.

15. The method of claim 1, wherein the cancer is liver cancer.

16. The method of claim 1, wherein the cancer is pancreatic cancer.

17. The method of claim 1, wherein the cancer is nasopharyngeal cancer.

18. The method of claim 1, wherein the cancer is cervical cancer.

19. The method of claim 1, wherein the cancer is multiple myeloma.

Details for Patent 10,278,934

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Merck ELSPAR asparaginase VIAL 101063 001 1978-01-10   Start Trial Biosuccess Biotech Co., Ltd. (San Jose, CA) 2027-01-31 RX search
Chiron PROLEUKIN aldesleukin VIAL 103293 001 1992-05-05   Start Trial Biosuccess Biotech Co., Ltd. (San Jose, CA) 2027-01-31 RX search
Wyeth Pharms Inc MYLOTARG gemtuzumab ozogamicin VIAL;SINGLE-DOSE 761060 001 2018-04-09   Start Trial Biosuccess Biotech Co., Ltd. (San Jose, CA) 2027-01-31 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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