You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Claims for Patent: 8,580,857


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,580,857
Title:Methods and compositions to determine the chemosensitizing dose of suramin used in combination therapy
Abstract: A method for determining a therapeutically effective amount of suramin for administering to a patient, who is to receive a cytotoxic agent, which comprises the steps of determining the circulating suramin concentration in the patient; administering suramin, if required, to establish a low circulating concentration of suramin in the patient of below about 200 .mu.M; and administering the chemotherapeutic agent to the patient when the low circulating concentration of suramin is present in the patient. Conveniently a nomogram can be constructed for use in clinical settings with the suramin.
Inventor(s): Au; Jessie L. -S. (Columbus, OH), Wientjes; M. Guillaume (Columbus, OH)
Assignee:
Application Number:13/031,306
Patent Claims:1. A method for determining a therapeutically effective amount of suramin for administering to a patient, who is to receive a cytotoxic agent, which comprises the steps of: (a) determining the gender and the squared value of the body surface area (BSA) of said patient; (b) determining the time elapsed, in days, since the initiation of the last suramin treatment; and (c) calculating the dose of low dose suramin using a nomogram that shows the dose according to the parameters of gender, squared value of body surface area, and elapsed days since last suramin treatment, wherein said nomogram comprises: Nomogram for Calculating Suramin Dose TABLE-US-00009 Cycle 1* Days elapsed since FACTOR the initiation Man Woman of the last 125 125 suramin treatment FACTOR 7 39 33 8 43 37 9 47 40 10 51 44 11 55 47 12 58 50 13 61 53 14 64 56 15 67 58 16 70 61 17 72 63 18 74 66 19 77 68 20 79 70 21 80 72 22 82 74 23 84 75 24 86 77 25 87 79 26 88 80 27 90 82 28 91 83 29 92 84 30 93 86 31 94 87 32 95 88 33 96 89 34 97 90 35 98 91 36 98 92 37 99 93 38 100 94 39 100 95 41 102 96 42 102 97 44 103 98 47 104 100 49 105 101 52 106 102 55 106 103

where: Dose (mg)=FACTOR*BSA.sup.2 wherein "BSA" is body surface area in units of m.sup.2.

2. A method for determining a therapeutically effective amount of suramin for administering to a patient, who is to receive a cytotoxic agent, which comprises the steps of: (a) determining the squared value of the body surface area (BSA) of said patient; (b) determining the time elapsed, in days, since the initiation of the last suramin treatment; and (c) calculating the dose of low dose suramin using a nomogram that shows the dose according to the parameters of squared value of body surface area, and elapsed days since last suramin treatment, and where said nomogram comprises: TABLE-US-00010 Nomogram for Calculating Suramin Dose Days elapsed since Cycle 1* the initiation of the last 125 suramin treatment FACTOR 7 39 8 43 9 47 10 51 11 55 12 58 13 61 14 64 15 67 16 69 17 72 18 74 19 76 20 78 21 80 22 82 23 84 24 86 25 87 26 88 27 90 28 91 29 92 30 93 31 94 32 95 33 96 34 97 35 98 36 98 37 99 38 100 39 100 41 102 42 102 44 103 47 104 49 105 52 106 55 106

where: Dose (mg)=FACTOR*BSA.sup.2 wherein "BSA" is body surface area in units of m.sup.2.

3. The method of claim 2, wherein said cytotoxic agent is one or more of an anti-microtubule agent, a topoisomerase I inhibitor, a topoisomerase II inhibitor, an anti-metabolite, a mitotic inhibitor, an alkylating agent, an intercalating agent, an agent capable of interfering with a signal transduction pathway, an agent that promotes one or more of apoptosis or necrosis, an interferon, an interleukin, a tumor necrosis factor, or radiation.

4. The method of claim 3, wherein said cytotoxic agent is one or more of paclitaxel, vincristine, vinblastine, vindesine, vinorelbin, docetaxel, topotecan, camptothecin, irinotecan hydrochloride, doxorubicin, etoposide, mitoxantrone, daunorubicin, idarubicin, teniposide, amsacrine, epirubicin, merbarone, piroxantrone hydrochloride, 5-fluorouracil, methotrexate, 6-mercaptopurine, 6-thioguanine, fludarabine phosphate, cytosine arabinoside, trimetrexate, gemcitabine, acivicin, alanosine, pyrazofurin, N-phosphoracetyl-L-aspartate (PALA), pentostatin, 5-azacitidine, 5-aza-2'-deoxycytidine, adenosine arabinoside, cladribine, ftorafur, uracil/ftorafur combinations, 5-fluoro-2'-deoxyuridine, 5'-deoxy-5-fluorouridine, tiazofurin, capecitabine, cisplatin, carboplatin, oxaliplatin, mitomycin C, BCNU, melphalan, thiotepa, busulfan, chlorambucil, plicamycin, dacarbazine, ifosfamide phosphate, cyclophosphamide, nitrogen mustard, uracil mustard, pipobroman, 4-ipomeanol, dihydrolenperone, spiromustine, geldanamycins, cytochalasins, depsipeptide, leuprolide, ketoconazole, tamoxifen, goserelin, flutamide, 4'-cyano-3-(4-fluorophenylsulphonyl)-2-hydroxy-2-methyl-3'-(trifluorometh- yl) propionanilide, trastuzumab, anti-CD20, cetuximab, gefitinib, interferon alpha, interferon beta, interferon gamma, interleukin 2, interleukin 4, interleukin 12, tumor necrosis factors, radiation, hydroxyurea, azathioprine, aminopterin, trimethoprin, pyrimethamine, pyritrexim, DDMP (2,4 diamino- 5(3', 4' dichlorophenyl)6 methylpyrimidine), 5,10-dideazatetrahydrofolate, 10-propargyl-5,8 dideazafolate, 10-ethyl-10-deaza-aminopterin, deoxycytidine, 5-aza-cytosine arabinoside, N-4-palmitoyl-ara C, 2'-azido-2'-deoxy-ara C, N4-behenoyl-ara C, CCNU, estramustine, MeCCNU, triethylene melamine, trenimon, dimethyl busulfan, streptozotocin, chlorozotocin, procarbazine, hexamethylmelamine, pentamethylmelamine, tetraplatin, oxaliplatin, platinum-DACH, aziridinylbenzoquinone, bleomycin, tallysomycin S.sub.10.sup.b, liblomycin, pepleomycin, asparaginase, pegaspargase, leustatin, porfimer sodium, amonofide, deoxyspergualin, dihydrolenperone, flavone acetic acid, gallium nitrate, or hexamethylene bisacetamine.

5. A method for treating a patient with suramin for administering to a patient, who is to receive a cytotoxic agent, which comprises the steps of: (a) determining a therapeutically effective amount of suramin for administering to said patient, which comprises the steps of: (a1) determining the squared value of the body surface area (BSA) of said patient; (a2) determining the time elapsed, in days, since the initiation of the last suramin treatment; and (a3) calculating the dose of low dose suramin using a nomogram that shows the dose according to the parameters of squared value of body surface area, and elapsed days since last suramin treatment, wherein said nomogram comprises: TABLE-US-00011 Nomogram for Calculating Suramin Dose Days elapsed since Cycle 1 the initiation of the 125 last suramin treatment FACTOR 7 39 8 43 9 47 10 51 11 55 12 58 13 61 14 64 15 67 16 69 17 72 18 74 19 76 20 78 21 80 22 82 23 84 24 86 25 87 26 88 27 90 28 91 29 92 30 93 31 94 32 95 33 96 34 97 35 98 36 98 37 99 38 100 39 100 41 102 42 102 44 103 47 104 49 105 52 106 55 106

where: Dose (mg) =FACTOR*BSA.sup.2 wherein "BSA" is body surface area in units of m.sup.2; (b) administering said calculated dose of suramin to said patient; and (c) administering said cytotoxic agent to said patient.

6. The method of claim 5, wherein a suramin dose is administered such that a concentration of between about 10 .mu.M to about 50 .mu.M between about 4 hours and about 48 hours after suramin administration is achieved in a patient.

7. The method of claim 5, wherein the patient is a mammal.

8. The method of claim 7, wherein the patient is a human.

9. The method of claim 5, wherein the patient has a tumor.

10. The method of claim 5, wherein the cytotoxic agent is one or more of carboplatin or paclitaxel.

11. The method of claim 5, wherein two-thirds of the therapeutically effective amount of suramin is given on the first day and the remaining one-third of the therapeutically effective amount of suramin is given about 24 hours later.

12. A method for treating a patient with suramin for administering to a patient, who is to receive a cytotoxic agent, which comprises the steps of: (a) determining a therapeutically effective amount of suramin for administering to said patient, which comprises the steps of: (a1) determining the gender and the squared value of the body surface area (BSA) of said patient; (a2) determining the time elapsed, in days, since the initiation of the last suramin treatment; and (a3) calculating the dose of low dose suramin using a nomogram that shows the dose according to the parameters of gender, squared value of body surface area, and elapsed days since last suramin treatment, wherein said nomogram comprises: TABLE-US-00012 Nomogram for Calculating Suramin Dose Cycle 1 FACTOR Days elapsed since Man Woman the initiation of the 125 125 last suramin treatment FACTOR 7 39 33 8 43 37 9 47 40 10 51 44 11 55 47 12 58 50 13 61 53 14 64 56 15 67 58 16 70 61 17 72 63 18 74 66 19 77 68 20 79 70 21 80 72 22 82 74 23 84 75 24 86 77 25 87 79 26 88 80 27 90 82 28 91 83 29 92 84 30 93 86 31 94 87 32 95 88 33 96 89 34 97 90 35 98 91 36 98 92 37 99 93 38 100 94 39 100 95 41 102 96 42 102 97 44 103 98 47 104 100 49 105 101 52 106 102 55 106 103

where: Dose (mg) =FACTOR*BSA.sup.2 wherein "BSA" is body surface area in units of m.sup.2; (b) administering said calculated dose of suramin to said patient; and (c) administering said cytotoxic agent to said patient.

13. The method of claim 12, wherein a suramin dose is administered such that a concentration of between about 10 .mu.M to about 50 .mu.M between about 4 hours and about 48 hours after suramin administration is achieved in a patient.

14. The method of claim 12, wherein the patient is a mammal.

15. The method of claim 14, wherein the patient is a human.

16. The method of claim 12, wherein the patient has a tumor.

17. The method of claim 12, wherein the cytotoxic agent is one or more of carboplatin or paclitaxel.

18. The method of claim 12, wherein two-thirds of the therapeutically effective amount of suramin is given on the first day and the remaining one-third of the therapeutically effective amount of suramin is given about 24 hours later.

Details for Patent 8,580,857

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Recordati Rare Diseases, Inc. ELSPAR asparaginase For Injection 101063 01/10/1978 ⤷  Try a Trial 2021-09-24
Servier Pharmaceuticals Llc ONCASPAR pegaspargase Injection 103411 02/01/1994 ⤷  Try a Trial 2021-09-24
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2021-09-24
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 02/10/2017 ⤷  Try a Trial 2021-09-24
Eli Lilly And Company ERBITUX cetuximab Injection 125084 02/12/2004 ⤷  Try a Trial 2021-09-24
Eli Lilly And Company ERBITUX cetuximab Injection 125084 03/28/2007 ⤷  Try a Trial 2021-09-24
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 02/28/2019 ⤷  Try a Trial 2021-09-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.