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Claims for Patent: 6,635,234

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Claims for Patent: 6,635,234

Title: Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
Abstract:Processes for the preparation, prepared solutions, and the use of radium-223 for the treatment of calcified tumors, bone tumors, treatment of bones, bone surfaces and soft tissues is described.
Inventor(s): Larsen; Roy H. (Bekkestua, NO), Henriksen; Gjermund (Mj.o slashed.ndalen, NO), Bruland; .O slashed.yvind S. (Hosle, NO)
Assignee: Anticancer Therapeutic Inventions AS (Oslo, NO)
Application Number:09/476,569
Patent Claims: 1. A method for the prophylactic or therapeutic treatment of a metastasis from a soft tissue tumor to a bone in a mammal, said method comprising administering to the mammal in need therof, a therapeutically or prophylactically effective amount of a free metallic cation of the alkaline earth metal radium-223.

2. A method as claimed in claim 1 wherein radium-223 is administered as a salt in solution.

3. The method of claim 2, wherein said method further comprises co-administering a further alkaline earth metal cation.

4. A method as claimed in claim 3 wherein said further cation is selected from the group consisting of magnesium, calcium and strontium.

5. A method as claimed in claim 2 wherein there is co-administered an agent serving to prevent precipitation of radium-223.

6. A method as claimed in claim 2 wherein there is co-administered an agent serving to prevent colloid generation.

7. A method as claimed in claim 1 wherein said mammal is a human.

8. A method a claimed in claim 1 wherein said amount is a therapeutically effective amount.

9. A method as claimed in claim 1 wherein said amount is prophylactically effective amount.

10. The method of claim 1, wherein said method is used to treat a metastasis resulting from a malignant disease selected from the group consisting of prostate cancer, breast cancer, kidney and urinary tract cancers, lung cancer, and multiple myeloma.

11. The method of claim 1, wherein said method further comprises administering to said mammal a therapeutic treatment selected from the group consisting of chemotherapy, surgery, external beam irradiation, low linear energy transfer radiation emitting bone-seeking radio-pharmaceutical treatment, hormonal treatment, and a combination therapy comprising radium-223 and a bisphosphonate.

12. A method as claim in claim 5 or claim 6 wherein there is co-administered a carboxylic acid.

13. A method as claimed in claim 12 wherein said carboxylic acid is selected from the group consisting of oxalic, oxaloacetic, tartaric, succinic, malic and malonic acids.

14. A method as claimed in claim 1 wherein said radium-223 is administered by injection.

15. A method as claimed in claim 1 wherein said radium-223 is administered by infusion.

16. A method as claimed in claim 1 wherein said radium-223 is administered by ingestion.

17. The method of claim 1, wherein said therapeutically or prophylactically effective amount is in the range 50 kBq to 10 MBq.

18. The method of claim 1, wherein said administering is carried out by an intravenous or an intraarterial route.

19. The method of claim 1, wherein said metastasis is on a surface of said bone.

20. The method of claim 1, wherein said administering is systemic administering.
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