RU2002100905A - Humanized Antibodies to ErB2 and Treatment Using Antibodies to ErB2 - Google Patents

Humanized Antibodies to ErB2 and Treatment Using Antibodies to ErB2

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RU2002100905A
RU2002100905A RU2002100905/14A RU2002100905A RU2002100905A RU 2002100905 A RU2002100905 A RU 2002100905A RU 2002100905/14 A RU2002100905/14 A RU 2002100905/14A RU 2002100905 A RU2002100905 A RU 2002100905A RU 2002100905 A RU2002100905 A RU 2002100905A
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antibody
cancer
ability
erbb2
application
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RU2002100905/14A
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Russian (ru)
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RU2270029C2 (en
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Камеллиа У. АДАМС
Ленард Г. ПРЕСТА
Марк СЛИВКОВСКИ
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Джинентех, Инк.
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1. Способ лечения рака у человека, где раковые клетки экспрессируют рецептор эпидермального фактора роста (EGFR), заключающийся в том, что человеку вводят терапевтически эффективное количество антитела, которое обладает способностью связывать ErbB2.1. A method of treating cancer in humans, where the cancer cells express an epidermal growth factor receptor (EGFR), the method comprising administering to a human a therapeutically effective amount of an antibody that has the ability to bind ErbB2. 2. Способ по п.1, где антитело обладает способностью блокировать активацию лигандом рецептора ErbB.2. The method according to claim 1, where the antibody has the ability to block ligand activation of the ErbB receptor. 3. Способ по п.2, где антитело обладает способностью блокировать связывание моноклонального антитела 2С4 с ErbB2.3. The method according to claim 2, where the antibody has the ability to block the binding of monoclonal antibodies 2C4 with ErbB2. 4. Способ по п.1, где рак характеризуется чрезмерной активацией EGFR.4. The method according to claim 1, where the cancer is characterized by excessive activation of EGFR. 5. Способ по п.4, где раковые клетки обладают способностью сверх-экспрессировать лиганд ErbB.5. The method according to claim 4, where the cancer cells have the ability to over-express the ErbB ligand. 6. Способ по п.5, где лиганд ErbB представляет собой трансформирующий фактор роста альфа (TGF-α).6. The method according to claim 5, where the ErbB ligand is a transforming growth factor alpha (TGF-α). 7. Способ по п.1, где антитело обладает способностью блокировать опосредуемую TGF-α активацию протеинкиназы, активируемой с помощью митогена (МАРК).7. The method according to claim 1, where the antibody has the ability to block TGF-α mediated activation of mitogen activated protein kinase (MAPK). 8. Способ по п.1, где раковые клетки не обладают способностью сверх-экспрессировать рецептор ErbB2.8. The method according to claim 1, where the cancer cells do not have the ability to over-express the ErbB2 receptor. 9. Способ по п.1, где рак выбирают из группы, включающей рак ободочной кишки, прямой кишки и колоректальный рак.9. The method according to claim 1, where the cancer is selected from the group comprising cancer of the colon, rectum and colorectal cancer. 10. Способ по п.9, дополнительно предусматривающий введение пациенту химиотерапевтического агента.10. The method according to claim 9, further comprising administering to the patient a chemotherapeutic agent. 11. Способ по п.10, где химиотерапевтический агент выбирают из группы, включающей 5-флуорацил (5-FU), леуковорин (LV), СРТ-1 1 и левамизол.11. The method of claim 10, wherein the chemotherapeutic agent is selected from the group consisting of 5-fluoracil (5-FU), leucovorin (LV), CPT-1 1 and levamisole. 12. Способ по п.1, где рак представляет собой рак легкого.12. The method according to claim 1, where the cancer is lung cancer. 13. Способ по п.12, где рак представляет собой немелкоклеточный рак легкого.13. The method of claim 12, wherein the cancer is non-small cell lung cancer. 14. Способ по п.12, дополнительно предусматривающий введение человеку химиотерапевтического агента.14. The method of claim 12, further comprising administering to the human a chemotherapeutic agent. 15. Способ по п.14, где химиотерапевтический агент выбирают из группы, включающей таксан, гемцитабин, навелбин, цисплатин, оксалиплатин и карбоплатин.15. The method of claim 14, wherein the chemotherapeutic agent is selected from the group consisting of taxane, gemcitabine, Navelbin, cisplatin, oxaliplatin and carboplatin. 16. Способ по п.1, где антитело обладает биологическими характеристиками моноклонального антитела 2С4.16. The method according to claim 1, where the antibody has the biological characteristics of a monoclonal antibody 2C4. 17. Способ по п.16, где антитело представляет собой моноклональное антитело 2С4 или гуманизированное антитело 2С4.17. The method according to clause 16, where the antibody is a monoclonal antibody 2C4 or a humanized antibody 2C4. 18. Способ по п.1, где антитело представляет собой фрагмент антитела.18. The method according to claim 1, where the antibody is an antibody fragment. 19. Способ по п.18, где фрагмент антитела представляет собой Fab-фрагмент.19. The method of claim 18, wherein the antibody fragment is a Fab fragment. 20. Способ по п.1, где антитело не конъюгировано с цитотоксическим агентом.20. The method according to claim 1, where the antibody is not conjugated with a cytotoxic agent. 21. Способ по п.1, где фрагмент антитела не конъюгирован с цитотоксическим агентом.21. The method according to claim 1, where the antibody fragment is not conjugated to a cytotoxic agent. 22. Способ по п.1, где антитело конъюгировано с цитотоксическим агентом.22. The method according to claim 1, where the antibody is conjugated to a cytotoxic agent. 23. Способ по п.1, дополнительно предусматривающий введение пациенту терапевтически эффективного количества второго терапевтического агента, выбранного из группы, включающей второе отличное от первого антитело, которое обладает способностью связывать ErbB2, химиотерапевтический агент, лекарственное средство, мишенью которого является EGFR, антиангиогенный агент, антигормональное соединение, кардиозащитное средство и цитокин.23. The method according to claim 1, further comprising administering to the patient a therapeutically effective amount of a second therapeutic agent selected from the group comprising a second antibody different from the first, which has the ability to bind ErbB2, a chemotherapeutic agent, a drug targeted at EGFR, an antiangiogenic agent, antihormonal compound, cardioprotective agent and cytokine. 24. Способ по п.1, заключающийся в том, что человеку вводят по меньшей мере одну дозу антитела в количестве от приблизительно 0,5 до приблизительно 10 мг/кг.24. The method according to claim 1, which consists in the fact that the person is administered at least one dose of the antibody in an amount of from about 0.5 to about 10 mg / kg 25. Способ по п.24, предусматривающий введение дозы приблизительно один раз в неделю.25. The method according to paragraph 24, comprising administering a dose approximately once a week. 26. Способ по п.24, предусматривающий введение дозы приблизительно один раз в три недели.26. The method according to paragraph 24, comprising administering a dose of approximately once every three weeks. 27. Способ лечения рака у человека, где раковые клетки не обладают способностью сверх-экспрессировать рецептор ErbB2, заключающийся в том, что человеку вводят терапевтически эффективное количество антитела, которое связывает ErbB2 и блокирует активацию лигандом рецептора ErbB2.27. A method for treating cancer in humans, where the cancer cells do not have the ability to over-express the ErbB2 receptor, the method comprising administering a therapeutically effective amount of an antibody that binds ErbB2 and blocks ligand activation of the ErbB2 receptor. 28. Способ по п.27, где рак представляет собой рак молочной железы.28. The method according to item 27, where the cancer is breast cancer. 29. Способ по п.28, где рак представляет собой метастатический рак молочной железы.29. The method of claim 28, wherein the cancer is metastatic breast cancer. 30. Способ по п.28, дополнительно предусматривающий введение человеку химиотерапевтического агента.30. The method of claim 28, further comprising administering to the human a chemotherapeutic agent. 31. Способ по п.30, где химиотерапевтический агент выбирают из группы, включающей антрациклиновый антибиотик, циклофосфомид, таксан, нанавелбин, кселода, митомицин С, оксалиплатин, гемцитабин и соединение на основе платины.31. The method of claim 30, wherein the chemotherapeutic agent is selected from the group consisting of an anthracycline antibiotic, cyclophosphomide, taxane, nanovelbin, xeloda, mitomycin C, oxaliplatin, gemcitabine, and a platinum-based compound. 32. Способ лечения рака у человекаа, заключающийся во введении пациенту терапевтически эффективных количеств (а) первого антитела, обладающего способностью связывать ErbB2 и ингибировать рост раковых клеток, которые сверхэкспрессируют ErbB2; и (б) второго антитела, обладающего способностью связывать ErbB2 и блокировать активацию лигандом рецептора ErbB.32. A method of treating cancer in a person, comprising administering to the patient therapeutically effective amounts of (a) a first antibody having the ability to bind ErbB2 and inhibit the growth of cancer cells that overexpress ErbB2; and (b) a second antibody having the ability to bind ErbB2 and block ligand activation of the ErbB receptor. 33. Способ по п.32, где первое антитело представляет собой моноклональное антитело 4D5 или гуманизированное антитело 4D5, а второе антитело представляет собой моноклональное антитело 2С4 или гуманизированное антитело 2С4.33. The method according to p, where the first antibody is a 4D5 monoclonal antibody or 4D5 humanized antibody, and the second antibody is a 2C4 monoclonal antibody or 2C4 humanized antibody. 34. Способ лечения рака у человека, где рак выбирают из группы, включающей рак ободочной кишки, прямой кишки и колоректальный рак, заключающийся в том, что человеку вводят терапевтически эффективное количество антитела, которое обладает способностью связывать ErbB2 и блокировать активацию лигандом рецептора ErbB.34. A method for treating cancer in humans, wherein the cancer is selected from the group consisting of colon, rectal and colorectal cancer, the method comprising administering to a person a therapeutically effective amount of an antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor. 35. Форма для применения, представляющая собой контейнер и содержащуюся в нем композицию, где композиция представляет собой антитело, которое обладает способностью связывать ErbB2, и, кроме того, включающая вкладыш для упаковки, на котором указано, что композиция может применяться для лечения рака, при котором раковые клетки экспрессируют рецептор эпидермального фактора роста (EGFR).35. A use form comprising a container and the composition contained therein, wherein the composition is an antibody that has the ability to bind ErbB2, and further comprising a package insert that indicates that the composition can be used to treat cancer, when wherein cancer cells express an epidermal growth factor receptor (EGFR). 36. Форма для применения, представляющая собой контейнер и содержащуюся в нем композицию, где композиция представляет собой антитело, которое обладает способностью связывать ErbB2 и блокировать активацию лигандом рецептора ErbB, и, кроме того, включающая вкладыш для упаковки, на котором указано, что композиция может применяться для лечения рака, при котором раковые клетки не обладают способностью сверхэкспрессировать рецептор ErbB2.36. A use form comprising a container and the composition contained therein, wherein the composition is an antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor, and further comprising a package insert that indicates that the composition may used to treat cancer in which cancer cells do not have the ability to overexpress the ErbB2 receptor. 37. Форма для применения, представляющая собой (а) первый контейнер и содержащуюся в нем композицию, где композиция представляет собой первое антитело, которое обладает способностью связывать ErbB2 и ингибировать рост раковых клеток, сверхэкспрессирующих ЕrbВ2, и (б) второй контейнер и содержащуюся в нем композицию, где композиция представляет собой второе антитело, которое обладает способностью связывать ЕrbВ2 и блокировать активацию лигандом рецептора ErbB.37. A use form comprising (a) a first container and the composition contained therein, wherein the composition is a first antibody that has the ability to bind ErbB2 and inhibit the growth of cancer cells overexpressing ErbB2, and (b) a second container and contained therein a composition, wherein the composition is a second antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor. 38. Форма для применения по п.37, дополнительно включающая вкладыш для упаковки, на котором указано, что композиции, содержащие первое и второе антитела, могут применяться для лечения рака.38. The form for use according to clause 37, further comprising a liner for packaging, which indicates that compositions containing the first and second antibodies can be used to treat cancer. 39. Форма для применения, представляющая собой контейнер и содержащуюся в нем композицию, где композиция представляет собой антитело, которое обладает способностью связывать ЕrbВ2 и блокировать активацию лигандом рецептора ЕrbВ2, и дополнительно включающая вкладыш для упаковки, на котором указано, что композиция может применяться для лечения рака, выбранного из группы, включающей рак ободочной кишки, прямой кишки и колоректальный рак.39. A use form comprising a container and the composition contained therein, wherein the composition is an antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB2 receptor, and further comprising a package insert that indicates that the composition can be used for treatment cancer selected from the group including cancer of the colon, rectum and colorectal cancer. 40. Гуманизированное антитело, которое обладает способностью связывать ЕrbВ2 и блокировать активацию лигандом рецептора ErbB.40. A humanized antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor. 41. Гуманизированное антитело по п.40, которое может связывать ЕrbВ2 практически так же эффективно, как и мышиное моноклональное антитело 2С4.41. The humanized antibody of claim 40, which can bind ErbB2 is almost as effective as the murine monoclonal antibody 2C4. 42. Гуманизированное антитело по п.40, включающее вариабельную область тяжелой цепи (Vн), которая содержит остатки гипервариабельного участка, полученной из любого источника кроме человека, встроенные в человеческую Vн-область, и кроме того содержит замену в каркасном участке (FR) в положении, выбранном из группы, включающей 69Н, 71Н и 73Н, где обозначения соответствуют системе нумерации, описанной у Kabat (1991).42. The humanized antibody of claim 40, comprising the variable region of the heavy chain (V n ), which contains the remains of a hypervariable region obtained from any source other than humans, embedded in the human V n region, and furthermore contains a replacement in the framework region (FR ) in a position selected from the group consisting of 69H, 71H and 73H, where the designations correspond to the numbering system described by Kabat (1991). 43. Гуманизированное антитело по п.42, имеющее в FR замены в положениях 69Н, 71Н и 73Н.43. The humanized antibody of claim 42, having an FR substitution at positions 69H, 71H, and 73H. 44. Гуманизированное антитело по п.40, включающее остатки гипервариабельного участка (CDR) VH-области GFTFTDYTMX (SEQ ID NO:7); DVNPNSGGSIYNQRFKG (SEQ ID NO:8); и NLGPSFYFDY (SEQ ID NO:9).44. The humanized antibody of claim 40, comprising the remains of a hypervariable region (CDR) of the V H region of the GFTFTDYTMX (SEQ ID NO: 7); DVNPNSGGSIYNQRFKG (SEQ ID NO: 8); and NLGPSFYFDY (SEQ ID NO: 9). 45. Гуманизированное антитело по п.40, содержащее аминокислотную последовательность SEQ ID NO:4 VH-области.45. The humanized antibody of claim 40, comprising the amino acid sequence of SEQ ID NO: 4 V H region . 46. Гуманизированное антитело по п.40, включающее остатки гиперва-риабельного участка (CDR) VL-области KASQDVSIGVA (SEQ ID NO:10); SAS-YXXX (SEQ ID NO:11); и QQYYIYPYT (SEQ ID NO:12).46. The humanized antibody of claim 40, comprising the remains of a hypervariable region (CDR) of the V L region of KASQDVSIGVA (SEQ ID NO: 10); SAS-YXXX (SEQ ID NO: 11); and QQYYIYPYT (SEQ ID NO: 12). 47. Гуманизированное антитело по п.40, содержащее аминокислотную последовательность SEQ ID NO:3. VL-области.47. The humanized antibody of claim 40, comprising the amino acid sequence of SEQ ID NO: 3. V L -regions. 48. Гуманизированное антитело по п.40, представляющее собой интактное антитело IgGl.48. The humanized antibody of claim 40, which is an intact IgGl antibody. 49. Гуманизированное антитело по п.40, представляющее собой фрагмент антитела.49. The humanized antibody of claim 40, which is a fragment of an antibody. 50. Гуманизированное антитело по п.40, представляющее собой Fab-фрагмент.50. The humanized antibody of claim 40, which is a Fab fragment. 51. Созревшее антитело с выраженной аффинностью, которое обладает способностью связывать ErbB2 и блокировать активацию лигандом рецептора ErbB.51. A matured antibody with a pronounced affinity that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor. 52. Композиция, содержащая гуманизированное антитело по п.40 и фармацевтически приемлемый носитель.52. A composition comprising the humanized antibody of claim 40 and a pharmaceutically acceptable carrier. 53. Иммуноконъюгат, представляющий собой гуманизированное антитело по п.40, конъюгированное с цитотоксическим агентом.53. An immunoconjugate, which is a humanized antibody according to claim 40, conjugated to a cytotoxic agent. 54. Выделенная нуклеиновая кислота, кодирующая гуманизированное антитело по п.40.54. The isolated nucleic acid encoding the humanized antibody of claim 40. 55. Вектор, содержащий нуклеиновую кислоту по п.54.55. A vector containing the nucleic acid according to item 54. 56. Клетка-хозяин, содержащая вектор по п.55.56. A host cell containing the vector of claim 55. 57. Способ получения гуманизированного антитела, заключающийся в том, что клетку-хозяина по п.56 культивируют таким образом, чтобы осуществлялась экспрессия нуклеиновой кислоты.57. A method of obtaining a humanized antibody, which consists in the fact that the host cell according to item 56 is cultured in such a way that expression of the nucleic acid is carried out. 58. Способ по п.57, дополнительно предусматривающий выделение гуманизированного антитела из культуры клеток-хозяев.58. The method of claim 57, further comprising isolating the humanized antibody from the host cell culture. 59. Способ по п.58, где гуманизированное антитело выделяют из среды, содержащей культуру клеток-хозяев.59. The method of claim 58, wherein the humanized antibody is isolated from a medium containing a host cell culture. 60. Применение антитела, которое обладает способностью связывать ErbB2, для приготовления лекарственного средства, предназначенного для лечения рака у человека, отличающееся тем, что раковые клетки экспрессируют рецептор эпидермального фактора роста (EGFR).60. The use of an antibody that has the ability to bind ErbB2, for the preparation of a medicinal product intended for the treatment of cancer in humans, characterized in that the cancer cells express an epidermal growth factor receptor (EGFR). 61. Применение по п.60, где антитело обладает способностью блокировать активацию лигандом рецептора ErbB.61. The application of claim 60, wherein the antibody has the ability to block ligand activation of the ErbB receptor. 62. Применение по п.61, где антитело обладает способностью блокировать связывание моноклонального антитела 2С4 с ErbB2.62. The use of claim 61, wherein the antibody has the ability to block the binding of a 2C4 monoclonal antibody to ErbB2. 63. Применение по п.60, где рак отличается повышенной активацией EGFR.63. The application of claim 60, wherein the cancer is characterized by increased activation of EGFR. 64. Применение по п.63, где раковые клетки обладают способностью сверхэкспрессировать лиганд ЕrbВ.64. The application of claim 63, wherein the cancer cells have the ability to overexpress the ErbB ligand. 65. Применение по п.64, где лиганд ЕrbВ представляет собой трансформирующий фактор роста альфа (TGF-α).65. The use of claim 64, wherein the ErbB ligand is a transforming growth factor alpha (TGF-α). 66. Применение по п.60, где антитело обладает способностью блокировать опосредуемую TGF-a активацию активируемой митогеном протеинкиназы (МАРК).66. The application of claim 60, wherein the antibody has the ability to block TGF-mediated activation of mitogen-activated protein kinase (MAPK). 67. Применение по п.60, где раковые клетки не обладают способностью сверхэкспрессировать рецептор ErbB2.67. The application of claim 60, wherein the cancer cells are not capable of overexpressing the ErbB2 receptor. 68. Применение по п.60, где рак выбирают из группы, включающей рак ободочной кишки, прямой кишки и колоректальный рак.68. The use of claim 60, wherein the cancer is selected from the group consisting of colon, rectal and colorectal cancer. 69. Применение по п.68, где лекарственное средство предназначено для введения совместно с химиотерапевтическим агентом.69. The use of claim 68, wherein the drug is intended to be administered in conjunction with a chemotherapeutic agent. 70. Применение по п.69, где химиотерапевтический агент выбирают из группы, включающей 5-флуорацил (5-FU), леуковорин (LV) СРТ-11 и левамизол.70. The application of claim 69, wherein the chemotherapeutic agent is selected from the group consisting of 5-fluoracil (5-FU), leucovorin (LV) CPT-11, and levamisole. 71. Применение по п.60, где рак представляет собой рак легкого.71. The use of claim 60, wherein the cancer is lung cancer. 72. Применение по п.71, где рак представляет собой немелкоклеточный рак легкого.72. The application of claim 71, wherein the cancer is non-small cell lung cancer. 73. Применение по п.71, где лекарственное средство предназначено для введения совместно с химиотерапевтическим агентом.73. The application of claim 71, wherein the drug is intended to be administered in conjunction with a chemotherapeutic agent. 74. Применение по п.73, где химиотерапевтический агент выбирают из группы, включающей таксан, гемцитабин, навелбин, цисплатин, оксалиплатин и карбоплатин.74. The application of claim 73, wherein the chemotherapeutic agent is selected from the group consisting of taxane, gemcitabine, Navelbin, cisplatin, oxaliplatin and carboplatin. 75. Применение по п.60, где антитело обладает биологическими характеристиками моноклонального антитела 2С4.75. The application of claim 60, wherein the antibody has the biological characteristics of a 2C4 monoclonal antibody. 76. Применение по п.75, где антитело представляет собой моноклональное антитело 2С4 или гуманизированное антитело 2С4.76. The application of claim 75, wherein the antibody is a 2C4 monoclonal antibody or a 2C4 humanized antibody. 77. Применение по п.60, где антитело представляет собой фрагмент антитела.77. The use of claim 60, wherein the antibody is an antibody fragment. 78. Применение по п.77, где фрагмент антитела представляет собой Fab-фрагмент.78. The application of claim 77, wherein the antibody fragment is a Fab fragment. 79. Применение по п.60, где антитело не конъюгировано с цитотоксическим агентом.79. The use of claim 60, wherein the antibody is not conjugated to a cytotoxic agent. 80. Применение по п.77, где фрагмент антитела не конъюгирован с цитотоксическим агентом.80. The application of claim 77, wherein the antibody fragment is not conjugated to a cytotoxic agent. 81. Применение по п.60, где антитело конъюгировано с цитотоксическим агентом.81. The use of claim 60, wherein the antibody is conjugated to a cytotoxic agent. 82. Применение по п.60, где лекарственное средство предназначено для введения человеку совместно с терапевтически эффективным количеством второго терапевтического агента, выбранного из группы, включающей второе отличное от первого антитело, которое обладает способностью связывать ErbB2, химиотерапевтический агент, лекарственное средство, мишенью которого является EGFR, антиангиогенный агент, антигормональное соединение, кардиозащитное средство и цитокин.82. The use of claim 60, wherein the medicament is intended to be administered to a person in conjunction with a therapeutically effective amount of a second therapeutic agent selected from the group consisting of a second antibody different from the first, which has the ability to bind ErbB2, a chemotherapeutic agent, a drug whose target is EGFR, anti-angiogenic agent, anti-hormonal compound, cardioprotective agent and cytokine. 83. Применение по п.60, где лекарственное средство предназначено для введения человеку по меньшей мере одной дозы антитела в количестве от приблизительно 0,5 до приблизительно 10 мг/кг.83. The use of claim 60, wherein the medicament is for administering to a human at least one dose of an antibody in an amount of from about 0.5 to about 10 mg / kg. 84. Применение по п.83, где лекарственное средство предназначено для введения дозы приблизительно один раз в неделю.84. The use of claim 83, wherein the drug is intended to be administered about once a week. 85. Применение по п.83, где лекарственное средство предназначено для введения дозы приблизительно один раз в три недели.85. The use of claim 83, wherein the drug is intended to be administered at about once every three weeks. 86. Применение антитела, которое обладает способностью связывать ErbB2 и блокировать активацию лигандом рецептора ErbB, для приготовления лекарственного средства, предназначенного для лечения у людей рака, где раковые клетки не обладают способностью сверхэкспрессировать рецептор ErbB2.86. Use of an antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor, for the preparation of a medicament intended for the treatment of cancer in humans where cancer cells do not have the ability to overexpress the ErbB2 receptor. 87. Применение по п.86, где рак представляет собой рак молочной железы.87. The application of claim 86, wherein the cancer is breast cancer. 88. Применение по п.87, где рак представляет собой метастатический рак молочной железы.88. The application of claim 87, wherein the cancer is metastatic breast cancer. 89. Применение по п.87, где лекарственное средство предназначено для введения человеку совместно с химиотерапевтическим агентом.89. The application of claim 87, wherein the medicament is intended to be administered to humans in association with a chemotherapeutic agent. 90. Применение по п.89, где химиотерапевтический агент выбирают из группы, включающей антрациклиновый антибиотик, циклофосфомид, таксан, навелбин, кселода, митомицин С, оксалиплатин, гемцитабин и соединение на основе платины.90. The application of claim 89, wherein the chemotherapeutic agent is selected from the group consisting of an anthracycline antibiotic, cyclophosphomide, taxane, Navelbin, xeloda, mitomycin C, oxaliplatin, gemcitabine, and a platinum-based compound. 91. Применение (а) первого антитела, обладающего способностью связывать ErbB2 и ингибировать рост раковых клеток, которые сверхэкспрессируют ErbB2; и (б) второго антитела, обладающего способностью связывать ErbB2 и блокировать активацию лигандом рецептора ЕrbВ, для приготовления лекарственного средства, предназначенного для лечения рака у человека.91. The use of (a) a first antibody having the ability to bind ErbB2 and inhibit the growth of cancer cells that overexpress ErbB2; and (b) a second antibody having the ability to bind ErbB2 and block ligand activation of the ErbB receptor for the preparation of a medicament for treating human cancer. 92. Применение по п.91, где первое антитело представляет собой моноклональное антитело 4D5 или гуманизированное антитело 4D5, а второе антитело представляет собой моноклональное антитело 2С4 или гуманизированное антитело 2С4.92. The application of claim 91, wherein the first antibody is a 4D5 monoclonal antibody or a 4D5 humanized antibody, and the second antibody is a 2C4 monoclonal antibody or a 2C4 humanized antibody. 93. Применение антитела, которое обладает способностью связывать ErbB2 и блокировать активацию лигандом рецептора ErbB, для приготовления лекарственного средства, предназначенного для лечения рака у человека, где рак выбирают из группы, включающей рак ободочной кишки, прямой кишки и колоректальный рак.93. The use of an antibody that has the ability to bind ErbB2 and block ligand activation of the ErbB receptor for the manufacture of a medicament for the treatment of cancer in humans, wherein the cancer is selected from the group consisting of colon, rectal and colorectal cancer. 94. Клетка-хозяин по п.56, представляющая собой клетку млекопитающего.94. A host cell according to claim 56, which is a mammalian cell. 95. Клетка-хозяин по п.94, представляющая собой клетку яичника китайского хомячка (СНО).95. The host cell according to clause 94, which is a Chinese hamster ovary (CHO) cell. 96. Клетка-хозяин по п.56, представляющая собой прокариотическую клетку.96. The host cell according to item 56, which is a prokaryotic cell. 97. Клетка-хозяин по п.96, представляющая собой клетку E.coli.97. The host cell of claim 96, which is an E. coli cell. 98. Антитело по любому из пп.40-51, сшитое с полимером, не содержащим протеина.98. The antibody according to any one of paragraphs.40-51, crosslinked with a protein-free polymer. 99. Антитело по п.98, где полимер, не содержащий протеина, представляет собой полиэтиленгликоль.99. The antibody of claim 98, wherein the protein-free polymer is polyethylene glycol. 100. Способ по п.23, где второй терапевтический агент представляет собой лекарственное средство, мишенью которого является EGFR.100. The method according to item 23, where the second therapeutic agent is a drug, the target of which is EGFR. 101. Способ по п.100, где лекарственное средство, мишенью которого является EGFR, представляет собой ZD1839, СР-358774 или AG1478.101. The method according to p, where the drug, the target of which is EGFR, is ZD1839, CP-358774 or AG1478. 102. Способ по п.100, где лекарственное средство, мишенью которого является EGFR, представляет собой антитело, которое обладает способностью связывать EGFR.102. The method according to p, where the drug, the target of which is EGFR, is an antibody that has the ability to bind EGFR. 103. Способ по п.102, где антитело, которое обладает способностью связывать EGFR, представляет собой С225 или Н225.103. The method of claim 102, wherein the antibody that has the ability to bind EGFR is C225 or H225. 104. Применение по п.82, где второй терапевтический агент представляет собой лекарственное средство, мишенью которого является EGFR.104. The application of claim 82, wherein the second therapeutic agent is a drug targeted at EGFR. 105. Применение по п.104, где лекарственное средство, мишенью которого является EGFR, представляет собой ZD1839, СР-358774 или AG1478.105. The use of claim 104, wherein the drug targeting EGFR is ZD1839, CP-358774, or AG1478. 106. Применение по п.104, где лекарственное средство, мишенью которого является EGFR, представляет собой антитело, которое обладает способностью связывать EGFR.106. The use of claim 104, wherein the drug targeting EGFR is an antibody that has the ability to bind EGFR. 107. Применение по п.106, где антитело, которое обладает способностью связывать EGFR, представляет собой С225 или Н225.107. The application of claim 106, wherein the antibody that has the ability to bind EGFR is C225 or H225.
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