Antifolate combination therapies

DC CAFC

US 7,772,209 B2
Filed: 07/11/2007
Issued: 08/10/2010
Est. Priority Date: 06/30/2000
Status: Expired due to Fees

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1. A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, whereinthe methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

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Abstract

A method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.

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22 Claims

1. A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, whereinthe methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- - 2. The method of claim 1, wherein the methylmalonic acid lowering agent is vitamin B12.
  - 3. The method of claim 2, wherein the vitamin B12 is administered as an intramuscular injection of about 500 μ
    - g to about 1500 μ
      
      g.
  - 4. The method of claim 2, wherein the vitamin B12 is administered as an intramuscular injection of about 1000 μ
    - g.
  - 5. The method of claim 2, 3 or 4, wherein the vitamin B12 administration is repeated about every 6 to about every 12 weeks following the administration of vitamin B12 until the administration of the pemetrexed disodium is discontinued.
  - 6. The method of claim 5 wherein the folic acid is administered 1 to 3 weeks prior to the first administration of the pemetrexed disodium.
  - 7. The method of claim 5 wherein the folic acid is administered from about 1 to about 24 hours prior to administration of the pemetrexed disodium.
  - 8. The method according to any one of claims 1-4, wherein between 0.3 mg to about 5 mg of folic acid is administered orally.
  - 9. The method of claim 8 wherein about 350 μ
    - g to about 1000 μ
      
      g of folic acid is administered.
  - 10. The method of claim 9 wherein 350 μ
    - g to 600 μ
      
      g of folic acid is administered.
  - 11. The method of claim 1 further comprising the administration of cisplatin to the patient.

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
- a) administration of between about 350 μ
  
  g and about 1000 μ
  
  g of folic acid prior to the first administration of pemetrexed disodium;
  
  b) administration of about 500 μ
  
  g to about 1500 μ
  
  g of vitamin B12, prior to the first administration of pemetrexed disodium; and
  
  c) administration of pemetrexed disodium.
- View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
- - 13. The method of claim 12 further comprising the administration of cisplatin to the patient.
  - 14. The method of claim 12, wherein vitamin B12 is administered as an intramuscular injection of about 500 μ
    - g to about 1500 μ
      
      g.
  - 15. The method of claim 14, wherein vitamin B12 is administered as an intramuscular injection of about 1000 μ
    - g.
  - 16. The method of claim 15, wherein between 0.3 mg to about 5 mg of folic acid is administered orally.
  - 17. The method of claim 16 wherein about 350 μ
    - g to about 1000 μ
      
      g of folic acid is administered.
  - 18. The method of claim 17 wherein 350 μ
    - g to 600 μ
      
      g of folic acid is administered.
  - 19. The method of claim 18 wherein folic acid is administered 1 to 3 weeks prior to the first administration of the pemetrexed disodium.
  - 20. The method of claim 18 wherein the folic acid is administered from about 1 to about 24 hours prior to administration of the pemetrexed disodium.
  - 21. The method of claim 12, 18, or 19, wherein the vitamin B12 administration is repeated about every 6 to about every 12 weeks following the administration of vitamin B12 until administration of pemetrexed disodium is discontinued.
  - 22. The method of claim 21 further comprising the administration of cisplatin to the patient.

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Litigation Data

Current Assignee
Eli Lilly and Company
Original Assignee
Eli Lilly and Company
Inventors
Niyikiza, Clet
Primary Examiner(s)
WEDDINGTON, KEVIN E

Application Number

US11/776,329
Publication Number

US 20080032948A1
Time in Patent Office

1,126 Days
Field of Search

514/52, 514/77, 514/249, 514/251, 514/265.1
US Class Current

514/52
CPC Class Codes

A61K 2300/00   Mixtures or combinations of...

A61K 31/519   ortho- or peri-condensed wi...

A61K 31/525   Isoalloxazines, e.g. ribofl...

A61K 31/70   Carbohydrates; Sugars; Deri...

A61K 31/714   Cobalamins, e.g. cyanocobal...

A61P 3/00   Drugs for disorders of the ...

A61P 3/02   Nutrients, e.g. vitamins, m...

A61P 35/00   Antineoplastic agents

A61P 43/00   Drugs for specific purposes...

Antifolate combination therapies

First Claim

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13 Petitions

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Abstract

26 Citations

22 Claims

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Antifolate combination therapies

First Claim

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13 Petitions

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Abstract

26 Citations

22 Claims

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