Granted Patent B2

US 12,691,081 · App. 17/141,499 · Granted Jul 28, 2026

Inventors: Niven Rajin Narain (Cambridge, MA); Rangaprasad Sarangarajan (Boylston, MA)

Assignee: BPGbio, Inc.

A61K31/122A61K31/4745A61K31/513A61K31/704A61K31/7068A61K33/243A61K39/39558A61K45/06C07K16/32

Abstract

Claims (32)

1 . A method of treating an oncological disorder in a subject comprising:

(a) administering coenzyme Q10 (CoQ10) to the subject by continuous intravenous infusion for at least 24 hours;

(b) discontinuing administration of CoQ10; and

(c) administering at least one chemotherapeutic agent to the subject after administration with CoQ10 has been discontinued,

such that the oncological disorder is treated,

wherein the oncological disorder is a solid tumor.

2 . A method of treating an oncological disorder in a subject comprising:

(a) administering coenzyme Q10 (CoQ10) to the subject by continuous intravenous infusion for at least 24 hours;

(b) administering at least one chemotherapeutic agent to the subject after administration of the CoQ10 is initiated; and

(c) continuing treatment with CoQ10 after administration of the at least one chemotherapeutic agent is initiated,

such that the oncological disorder is treated,

wherein the oncological disorder is a solid tumor.

3 . The method of claim 2 , wherein administration of the at least one chemotherapeutic agent is initiated at least 24 hours after administration of CoQ10 is initiated, one or more weeks after administration of CoQ10 is initiated, two or more weeks after administration of CoQ10 is initiated, three or more weeks after administration of CoQ10 is initiated, four or more weeks after administration of CoQ10 is initiated, five or more weeks after administration of CoQ10 is initiated, six or more weeks after administration of CoQ10 is initiated, seven or more weeks after administration of CoQ10 is initiated, or eight or more weeks after administration of CoQ10 is initiated.

4 . The method of claim 2 , wherein a response of the oncological disorder to treatment is improved relative to a treatment with the at least one chemotherapeutic agent alone.

5 . The method of claim 4 , wherein the response is improved by at least 5%, at least 10%, at least 15%, at least 20%, at least 30%, at least 40% or at least 50% relative to treatment with the at least one chemotherapeutic agent alone.

6 . The method of claim 4 , wherein the response comprises any one or more of reduction in tumor burden, reduction in tumor size, inhibition of tumor growth, achieving stable oncological disorder in a subject with a progressive oncological disorder prior to treatment, increased time to progression of the oncological disorder, and increased time of survival.

7 . The method of claim 2 , wherein the CoQ10 is administered at a dose of about 5 mg/kg, about 10 mg/kg, about 12.5 mg/kg, about 20 mg/kg, about 25 mg/kg, t about 30 mg/kg, about 35 mg/kg, about 40 mg/kg, about 45 mg/kg, about 50 mg/kg, about 55 mg/kg, about 58 mg/kg, about 58.6 mg/kg, about 60 mg/kg, about 75 mg/kg, about 78 mg/kg, about 100 mg/kg, about 104 mg/kg, about 125 mg/kg, about 150 mg/kg, about 175 mg/kg, about 200 mg/kg, about 300 mg/kg, or about 400 mg/kg.

8 . A method of improving a chemotherapeutic treatment regimen for an oncological disorder in a subject, comprising pre-treating a subject having an oncological disorder with Coenzyme Q10 (CoQ10) for a sufficient time prior to initiation of a chemotherapeutic treatment regimen, wherein the chemotherapeutic treatment regimen comprises administration of one or more chemotherapeutic agents, such that a response of the oncological disorder is improved relative to treatment with the chemotherapeutic treatment regimen alone, wherein the Coenzyme Q10 is administered by continuous intravenous infusion for at least 24 hours, and wherein the oncological disorder is a solid tumor.

9 . The method of claim 2 , wherein the at least one chemotherapeutic agent comprises a chemotherapeutic agent selected from the group consisting of a topoisomerase I inhibitor, a topoisomerase II inhibitor, a mitotic inhibitor, an alkylating agent, a platinum compound, and an antimetabolite.

10 . The method of claim 2 , wherein the at least one chemotherapeutic agent comprises a chemotherapeutic agent selected from the group consisting of amifostine (ethyol), cisplatin, dacarbazine (DTIC), dactinomycin, mechlorethamine (nitrogen mustard), streptozocin, cyclophosphamide, carrnustine (BCNU), lomustine (CCNU), doxorubicin (adriamycin), doxorubicin lipo (doxil), gemcitabine (gemzar), daunorubicin, daunorubicin lipo (daunoxome), procarbazine, mitomycin, cytarabine, etoposide, methotrexate, 5-fluorouracil (5-FU), vinblastine, vincristine, bleomycin, paclitaxel (taxol), docetaxel (taxotere), aldesleukin, asparaginase, busulfan, carboplatin, cladribine, camptothecin, CPT-11, 10-hydroxy-7-ethyl-camptothecin (SN38), dacarbazine, S-I capecitabine, ftorafur, 5′deoxyflurouridine, UFT, eniluracil, deoxycytidine, 5-azacytosine, 5-azadeoxycytosine, allopurinol, 2-chloro adenosine, trimetrexate, aminopterin, methylene-10-deazaaminopterin (MDAM), oxaplatin, picoplatin, tetraplatin, satraplatin, platinum-DACH, ormaplatin, CI-973, JM-216, and analogs thereof, epirubicin, etoposide phosphate, 9-aminocamptothecin, 10, 11-methylenedioxycamptothecin, karenitecin, 9-nitrocamptothecin, TAS 103, vindesine, L-phenylalanine mustard, ifosphamidemefosphamide, perfosfamide, trophosphamide carmustine, semustine, epothilones A-E, tomudex, 6-mercaptopurine, 6-thioguanine, amsacrine, etoposide phosphate, karenitecin, acyclovir, valacyclovir, ganciclovir, amantadine, rimantadine, lamivudine, zidovudine, bevacizumab, trastuzumab, rituximab, 5-Fluorouracil, Capecitabine, Pentostatin, Trimetrexate, Cladribine, floxuridine, fludarabine, hydroxyurea, ifosfamide, idarubicin, mesna, irinotecan, mitoxantrone, topotecan, leuprolide, megestrol, melphalan, mercaptopurine, plicamycin, mitotane, pegaspargase, pentostatin, pipobroman, plicamycin, streptozocin, tamoxifen, teniposide, testolactone, thioguanine, thiotepa, uracil mustard, vinorelbine, chlorambucil, cisplatin, doxorubicin, paclitaxel (taxol), bleomycin, mTor, epidermal growth factor receptor (EGFR), and fibroblast growth factors (FGF) and combinations thereof.

11 . The method of claim 2 , wherein the at least one chemotherapeutic agent comprises at least one of gemcitabine, 5-fluorouracil, cisplatin, capecitabine, methotrexate, edatrexate, docetaxel, cyclophosphamide, doxorubicin, and irinotecan.

12 . The method of claim 2 , wherein the oncological disorder is selected from the group consisting of a carcinoma, sarcoma, lymphoma, and melanoma.

13 . The method of claim 2 , wherein the oncological disorder is selected from the group consisting of pancreatic cancer, breast cancer, liver cancer, skin cancer, lung cancer, colon cancer, prostate cancer, thyroid cancer, bladder cancer, rectal cancer, endometrial cancer, kidney cancer, bone cancer, brain cancer, cervical cancer, stomach cancer, mouth and oral cancers, neuroblastoma, testicular cancer, uterine cancer, and vulvar cancer.

14 . The method of claim 2 , wherein the subject is human.

15 . The method of claim 2 , wherein the method comprises administering 5 mg/kg docetaxel, 1 mg/kg doxorubicin, and 35 mg/kg cyclophosphamide to the subject every three weeks for six cycles.

16 . The method of claim 2 , wherein the oncological disorder is glioblastoma.

17 . The method of claim 16 , wherein the at least one chemotherapeutic agent comprises an alkylating agent.

18 . The method of claim 1 , wherein the oncological disorder is selected from the group consisting of a carcinoma, sarcoma, lymphoma, and melanoma.

19 . The method of claim 1 , wherein the oncological disorder is selected from the group consisting of pancreatic cancer, breast cancer, liver cancer, skin cancer, lung cancer, colon cancer, prostate cancer, thyroid cancer, bladder cancer, rectal cancer, endometrial cancer, kidney cancer, bone cancer, brain cancer, cervical cancer, stomach cancer, mouth and oral cancers, neuroblastoma, testicular cancer, uterine cancer, and vulvar cancer.

20 . The method of claim 1 , wherein the subject is human.

21 . The method of claim 1 , wherein the oncological disorder is glioblastoma.

22 . The method of claim 21 , wherein the at least one chemotherapeutic agent comprises an alkylating agent.

Assignments (5)

Continuity (3)

References Cited (400)