WO2003105908B1 - Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs - Google Patents

Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs

Info

Publication number
WO2003105908B1
WO2003105908B1 PCT/US2003/007934 US0307934W WO03105908B1 WO 2003105908 B1 WO2003105908 B1 WO 2003105908B1 US 0307934 W US0307934 W US 0307934W WO 03105908 B1 WO03105908 B1 WO 03105908B1
Authority
WO
WIPO (PCT)
Prior art keywords
cell
mammal
administering
orosomucoid
glycoconjugate
Prior art date
Application number
PCT/US2003/007934
Other languages
French (fr)
Other versions
WO2003105908A2 (en
WO2003105908A3 (en
WO2003105908A9 (en
Inventor
Catherine A Phillips
Original Assignee
Dep Veterans Affairs Rehab R&D
Catherine A Phillips
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to CA002479309A priority Critical patent/CA2479309A1/en
Application filed by Dep Veterans Affairs Rehab R&D, Catherine A Phillips filed Critical Dep Veterans Affairs Rehab R&D
Priority to EP03748896A priority patent/EP1499347A2/en
Priority to AU2003267949A priority patent/AU2003267949A1/en
Priority to KR10-2004-7014544A priority patent/KR20050013531A/en
Priority to IL16407903A priority patent/IL164079A0/en
Priority to JP2004512808A priority patent/JP2006501169A/en
Publication of WO2003105908A2 publication Critical patent/WO2003105908A2/en
Publication of WO2003105908A9 publication Critical patent/WO2003105908A9/en
Publication of WO2003105908A3 publication Critical patent/WO2003105908A3/en
Publication of WO2003105908B1 publication Critical patent/WO2003105908B1/en
Priority to US10/940,691 priority patent/US20070110734A9/en
Priority to HK06100051.0A priority patent/HK1079987A1/en
Priority to AU2009201808A priority patent/AU2009201808A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/17—Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/34—Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48—Reproductive organs
    • A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48—Reproductive organs
    • A61K35/51—Umbilical cord; Umbilical cord blood; Umbilical stem cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A61K38/1741—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals alpha-Glycoproteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/549—Sugars, nucleosides, nucleotides or nucleic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells

Abstract

The present invention is directed to methods for delivering cells to a target tissue in a mammal using glycoconjugate to traffic the cell to a desired organ in the mammal. The methods according to the present invention are especially applicable to administering lymphoid cells such as natural killer (NK) cells activated with interleukin-2 (IL-2), lymphokine-activated killer (LAK) cells and/or tumor-infiltrating lymphocytes (TILs) and/or cytotoxic lymphocytes (CTLs), or stem cells such as those derived from the bone marrow or from umbilical cord tissue. The methods are also useful for targeting a gene of interest to a tissue in a mammal by introducing a cell containing the gene of interest and administering a glycoconjugate to the mammal.

Claims

53AMENDED CLAIMS[Received by the International Bureau on 29 October 2004 (29.10.04): original claims 2-23, 25-28, 30-33, 35-43 and 49 unchanged; claims 1, 24, 29, 34, 44, 48 and 50 amended; new claims 51-57 added (7 pages)]
1. A method for delivering a stem cell or lymphoid cell to a target tissue in a mammal comprising the steps of:
(a) administering a glycoconjugate to a mammal; and
(b) administering the cell to the mammal.
2. The method of claim 1, wherein the cell is a hematopoietic stem cell.
3. The method of claim 2, wherein the stem cell is obtained from the bone marrow, placenta, muscle, fat or an umbilical cord.
4. The method of claim 1 wherein the lymphoid cell is selected from the group consisting of a natural killer (NK) cell, a lymphokine-activated killer (LAK) cell, a tumor- infiltrating lymphocyte (TTL), a cytotoxic lymphocyte (CTL), and mixtures thereof.
5. The method of claim 1, wherein the glycoconjugate is represented by the general formula P-(S)x-Gal, wherein P is a peptide residue of a human serum glycoprotein and S is a sugar residue of a human serum glycoprotein; x is an integer from 1 to 100 and Gal is galactose residue,
6. The method of claim 1, wherein the glycoconjugate is selected from the group consisting of an orosomucoid and an asialoorosomucoid.
7. The method of claim 1, wherein the target tissue is a tissue of an organ selected from the group consisting of the heart, the liver, the lungs, and the kidneys. 54
8. The method of claim 1, wherein the glycoconjugate is administered to the mammal prior to the cell.
9. The method of claim 1, wherein the glycoconjugate and the cell are administered intravenously to the mammal.
10. A method for targeting a hematopoietic stem cell to the heart of a mammal comprising the steps of:
(a) administering an asialo-orosomucoid lo the mammal; and
(b) administering the cell to the mammal.
11. The method of claim 10, wherein the cell is administered after the step of administering the asialo-orosomucoid.
12. The method of claim 10, wherein the asialo-orosomucoid is administered via a vessel proximal to the heart.
13. The method of claim 12 wherein the asialo-orosomucoid is administered via a jugular vein.
14. The method of claim 10 wherein the heart of a mammal has suffered ischemic injury prior to administering the asialo-orosomucoid.
15. A method for targeting a mesenchymal stem cell to the heart of a mammal comprising the steps of:
(a) administering an orosomucoid to the mammal; and
(b) administering the cell to the mammal. 55
16. The method of claim 15, wherein the orosomucoid is administered via a vessel proximal to the heart.
17 Thf. method of claim 16 wherein the orosomucoid is administered via a iugular vein.
18. The method of claim 15 wherein the heart of a mammal has suffered ischemic injury prior to administering the orosomucoid.
19. The method of claim 15, wherein the cell is administered after the step of administering the orosomucoid.
20. A method for targeting a hematopoietic stem cell to the liver of a mammal comprising the steps of:
(a) administering an orosomucoid to the mammal; and
(b) administering the cell to the mammal.
21. The method of claim 20, wherein the cell is administered after the step of administering the orosomucoid.
22. A method for targeting a mesenchymal stem cell to the liver of a mammal comprising the steps of:
(a) administering an asialoorosornucoid to the mammal; and
(b) administering the cell to the mammal,
23. The method of claim 22, wherein the cell is administered after the step of administering the orosomucoid. 56
24. A method for targeting a gene of interest to a tissue in a mammal, said method comprising the steps of:
(a) introducing a cell comprising the gene of interest to the mammal; and
(b) administering a glycoconjugate.
25. The method of claim 24, wherein the cell is a hematopoietic stem cell.
26. The method of claim 24, wherein the cell is a lymphoid cell.
27. The method of claim 26, wherein the stem cell is obtained from the bone marrow, peripheral circulation or an umbilical cord.
28. The method of claim 24, wherein the glycoconjugate is selected from the group consisting of an orosomucoid and an asialoorosomucoid.
29. A method for treating a disease characterized by tissue damage in a mammal comprising the steps of;
(a) administering a stem cell to the mammal; and
(b) administering a glycoconjugate to the mammal.
30. The method of claim 29, wherein the stem cell is obtained from the hone marrow, peripheral circulation or an umbilical cord.
31. The method of claim 29, wherein the glycoconjugate is selected from the group consisting of an orosomucoid and an asialoorosomucoid.
32. The method of claim 29, wherein the disease is selected from the group consisting of a heart disease, a lung disease, a liver disease, a neurological disease and a kidney disease.
33. The method of claim 29, wherein the disease is selected from the group consisting of myocardial infarction, emphysema, cystic fibrosis, hepatitis, stroke, nephritis and microalbuminuri .
34. A pharmaceutical composition comprising a normal lymphoid cell or a stem cell and a glycoconjugate, wherein said glycoconjugate is a human serum glycoprotein.
35. The pharmaceutical composition of claim 34, wherein the glycoconjugate is selected from the group consisting of an orosomucoid and an asialoorosomucoid.
36. The pharmaceutical composition of claim 34, wherein the cell is a stem cell.
37. The pharmaceutical composition of claim 34, wherein the cell is a lymphoid cell.
38. An article of manufacture, comprising packaging material and a pharmaceutical composition contained within the packaging material, wherein the pharmaceutical composition comprises a glycoconjugate that is therapeutically effective for targeting a cell to a desired organ, and wherein the packaging material comprises a label which indicates that the pharmaceutical composition can be used for targeting a cell to a desired organ.
39. The article of manufacture of claim 38, further comprising additional reagents for making cell suspensions to be administered to a mammal and printed instructions, for use in targeting cells.
40. The article of manufacture of claim 39 further comprising a quantity of stem cells suitable for targeting of such cells in a mammal. 58
41. The article of manufacture of claim 38, wherein the glycoconjugate is selected from the group consisting of an orosomucoid and an asialoorosomucoid.
42. The article of manufacture of claim 40, wherein the cell is a hematopoietic stem cell.
-13, A mothod to improve the efficiency of an adoptive immunothcrapy using a lymphoid cell comprising modification of sialoglycoprotein determinants on the lymphoid cell surface.
44. The method of claim 43 wherein the modification comprises removal of sialic acid to generate new asialoglycoprotein deteπninants.
45. The method of claim 44 wherein the modification comprises removal of sialic acid by an enzyme.
46. The method of claim 45 wherein the modification comprises removal of sialic acid by a neuraminidase,
47. The method of claim 43 wherein the modification comprises addition of sialic acid by an enzyme.
48. The method of claim 43 wherein the adoptive immunotherapy is for a liver metastasis or a primary liver tumor and said method comprises regional administration to the liver of activated lymphocytes.
59
49. The method of claim 6 wherein the glycoconjugate is administered via a vessel proximal to the organ wherein the target tissue is located.
50. The method of claim 6 wherein the organ is the liver and the glycoconjugate is administered via the hepatic artery or portal vein or peripheral vein.
51. The method of claim 24 wherein the gene of interest comprises a transgene.
52. A method for delivering a stem cell to a target tissue in a mammal comprising the steps of:
(a) modifying sialoglycoprotein determinants on the cell surface; and
(b) administering the cell to the mammal.
53. The method of claim 52 wherein the modification comprises removal of sialic acid to generate new asialoglycoprotein determinants.
54. The method of claim 53 wherein the modification comprises removal of sialic acid by an enzyme.
55. The method of claim 54 wherein the modification comprises removal of sialic acid by a neura inidase.
56. The method of claim 52 wherein the modification comprises addition of sialic acid by an enzyme.
57. The method of claim 52 wherein the mammal has a disease characterized by a deficiency in a gene product and the stem cell comprises a functional gene encoding that gene product.
PCT/US2003/007934 2002-03-15 2003-03-14 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs WO2003105908A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
JP2004512808A JP2006501169A (en) 2002-03-15 2003-03-14 Methods and compositions for targeting cells to tissues and organs using cellular asialo determinants and glycoconjugates
EP03748896A EP1499347A2 (en) 2002-03-15 2003-03-14 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs
AU2003267949A AU2003267949A1 (en) 2002-03-15 2003-03-14 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs
KR10-2004-7014544A KR20050013531A (en) 2002-03-15 2003-03-14 Methods and Compositions Using Cellular Asialodeterminants and Glycoconjugates for Targeting Cells to Tissues and Organs
IL16407903A IL164079A0 (en) 2002-03-15 2003-03-14 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs
CA002479309A CA2479309A1 (en) 2002-03-15 2003-03-14 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs
US10/940,691 US20070110734A9 (en) 2002-03-15 2005-02-01 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs
HK06100051.0A HK1079987A1 (en) 2002-03-15 2006-01-04 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs
AU2009201808A AU2009201808A1 (en) 2002-03-15 2009-05-06 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US36449802P 2002-03-15 2002-03-15
US60/364,498 2002-03-15

Related Child Applications (1)

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US10/940,691 Continuation US20070110734A9 (en) 2002-03-15 2005-02-01 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs

Publications (4)

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WO2003105908A2 WO2003105908A2 (en) 2003-12-24
WO2003105908A9 WO2003105908A9 (en) 2004-03-04
WO2003105908A3 WO2003105908A3 (en) 2004-10-28
WO2003105908B1 true WO2003105908B1 (en) 2004-12-16

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PCT/US2003/007834 WO2003077864A2 (en) 2002-03-15 2003-03-14 Methods and compositions for directing cells to target organs
PCT/US2003/007836 WO2003077865A2 (en) 2002-03-15 2003-03-14 Methods and compositions for directing cells to target organs
PCT/US2003/007934 WO2003105908A2 (en) 2002-03-15 2003-03-14 Methods and compositions using cellular asialodeterminants and glycoconjugates for targeting cells to tissues and organs

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PCT/US2003/007836 WO2003077865A2 (en) 2002-03-15 2003-03-14 Methods and compositions for directing cells to target organs

Country Status (10)

Country Link
US (8) US7282222B2 (en)
EP (1) EP1499347A2 (en)
JP (1) JP2006501169A (en)
KR (1) KR20050013531A (en)
CN (1) CN100579577C (en)
AU (4) AU2003267949A1 (en)
CA (1) CA2479309A1 (en)
HK (1) HK1079987A1 (en)
IL (1) IL164079A0 (en)
WO (3) WO2003077864A2 (en)

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