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Claims for Patent: 6,987,102

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Claims for Patent: 6,987,102

Title:Methods to mobilize progenitor/stem cells
Abstract:Certain nitrogen-containing compounds that bind the chemokine receptor CXCR4 are able to mobilize progenitor and/or stem cells into the peripheral blood to permit harvesting them for stem cell transplantation.
Inventor(s): Bridger; Gary J. (Bellingham, WA), Abrams; Michael J. (Custer, WA), Henson; Geoffrey W. (Ferndale, WA), MacFarland; Ronald Trevor (Vancouver, CA), Calandra; Gary B. (Cresco, PA), Broxmeyer; Hal E. (Indianapolis, IN), Dale; David C. (Seattle, WA)
Assignee: Anormed, Inc. (Langley, CA)
Application Number:10/209,001
Patent Claims: 1. A method to obtain progenitor and/or stem cells from a subject which method comprises (a) administering to said subject a compound of the formula Z-linker-Z' (1) or pharmaceutically acceptable salt or prodrug form thereof wherein Z is a cyclic polyamine containing 9 32 ring members of which 2 8 are nitrogen atoms, said nitrogen atoms separated from each other by at least 2 carbon atoms, and wherein said heterocycle may optionally contain additional heteroatoms besides nitrogen and/or may be fused to an additional ring system; or Z is of the formula ##STR00003## wherein A comprises a monocyclic or bicyclic fused ring system containing at least one N and B is H or an organic moiety of 1 20 atoms, Z' is either embodied in a form as defined by Z above, or is of the formula --N(R)--(CR.sub.2).sub.n--X wherein each R is independently H or straight, branched or cyclic alkyl (1 6C), n is 1 or 2, and X is an aromatic ring, including heteroaromatic rings, or is a mercaptan; "linker" represents a bond, alkylene (1 6C) or may comprise aryl, fused aryl, and/or oxygen atoms contained in an alkylene chain, and/or may contain keto groups and/or nitrogen or sulfur atoms; in an amount effective to mobilize said progenitor and/or stem cells into the peripheral blood of said subject; followed by (b) harvesting said progenitor and/or stem cells by apheresis.

2. The method of claim 1 wherein Z and Z' are both cyclic polyamines.

3. The method of claim 1 wherein Z and Z' are identical.

4. The method of claim 1 wherein Z is a cyclic polyamine that contains 10 24 members and contains 4 nitrogen atoms.

5. The method of claim 3 wherein Z and Z' are both 1,4,8,11-tetraazocyclotetradecane.

6. The method of claim 1 wherein the linker comprises an aromatic ring bracketed by two methylene moieties.

7. The method of claim 6 wherein the linker is 1,4-phenylene-bis-methylene.

8. The method of claim 7 wherein the compound of formula (1) is 1,1'-[1,4-phenylene-bis-(methylene)]-bis-1,4,8,11-tetraazacyclotetradecan- e.

9. The method of claim 1 wherein Z is of the formula ##STR00004## wherein A comprises a monocyclic or bicyclic fused ring system containing at least one N and B is H or an organic moiety of 1 20 atoms.

10. The method of claim 1 wherein formula (1) is in the form of its acid addition salt.

11. The method of claim 10 wherein the acid addition salt is hydrochloride.

12. The method of claim 1 wherein the compound is administered to said subject by an intravenous or subcutaneous route.

13. The method of claim 1 wherein the compound of formula (1) is administered to said subject in the dosage range of about 0.1 .mu.g/kg 5 mg/kg of body weight.

14. The method of claim 1 which further comprises administering macrophage inflammatory protein to said subject.

15. The method of claim 1 which further comprises administering G-CSF to said subject prior to performing said method.

16. A method to obtain progenitor and/or stem cells from a subject which method comprises (a) administering to said subject an amount of a compound that binds to the chemokine receptor CXCR4 sufficient to mobilize said progenitor and/or stem cells into the peripheral blood of said subject; followed by (b) harvesting said progenitor and/or stem cells by apheresis.

17. The method of claim 4 wherein Z' is --N(R)--(CR.sub.2).sub.n--X wherein each R, N and X are as defined in claim 1.

18. The method of claim 17 wherein the linker is 1,4-phenylene-bis-(methylene).

19. The method of claim 18 wherein Z' is 2-aminomethyl-pyridine.

20. The method of claim 19 wherein the compound of formula (1) is N[1,4,8,11-tetraazacyclotetradecanyl-1,4-phenylene-bis-(methylene)]-2-ami- nomethyl-pyridine.

21. The method of claim 1 wherein the subject is human.

22. The method of claim 16 wherein the subject is human.
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