JP2000515553A - 単一の共有結合n末端水溶性ポリマーを有するポリペプチド - Google Patents
単一の共有結合n末端水溶性ポリマーを有するポリペプチドInfo
- Publication number
- JP2000515553A JP2000515553A JP10508173A JP50817398A JP2000515553A JP 2000515553 A JP2000515553 A JP 2000515553A JP 10508173 A JP10508173 A JP 10508173A JP 50817398 A JP50817398 A JP 50817398A JP 2000515553 A JP2000515553 A JP 2000515553A
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- polypeptide
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- polymer
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
- C07K1/1072—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups
- C07K1/1077—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups by covalent attachment of residues other than amino acids or peptide residues, e.g. sugars, polyols, fatty acids
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- 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
- A61K47/56—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 macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/475—Growth factors; Growth regulators
- C07K14/505—Erythropoietin [EPO]
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Toxicology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Peptides Or Proteins (AREA)
- Other Resins Obtained By Reactions Not Involving Carbon-To-Carbon Unsaturated Bonds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Addition Polymer Or Copolymer, Post-Treatments, Or Chemical Modifications (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.ペプチドもしくはタンパク質、ならびにポリペプチドのN末端のα−炭素原 子でそれに共有結合された水溶性ポリマーから本質的に成る物質の組成物であっ て、ただし、(a)ポリマーおよびポリペプチドがヒドラゾン結合もしくは還元 ヒドラゾン結合を介して相互に結合されており、(b)ポリマーは約200から約2 00,000ダルトンまでの分子量を有し、(c)ポリペプチドの本来の機能はそのN 末端のα−アミノ基の除去により消去されておらず、そして(d)タンパク質の N末端アミノ酸残基はセリンもしくはトレオニンでない、組成物。 2.ポリペプチド、ならびにポリペプチドのN末端のα−炭素原子でそれに共有 結合された水溶性ポリマーから本質的に成る物質の組成物であって、ただし、( a)ポリマーおよびポリペプチドがオキシム結合もしくは還元オキシム結合を介 して相互に結合されており、(b)ポリマーは約200から約200,000ダルトンまで の分子量を有し、そして(c)ポリペプチドの本来の機能はそのN末端のα−ア ミノ基の除去により消去されていない、組成物。 3.タンパク質がEPOもしくはその誘導体である、請求の範囲1の組成物。 4.ポリマーがPEGもしくはその誘導体である、請求の範囲1もしくは2の組 成物。 5.PEGもしくはその誘導体が約700から約20,000ダルトンまでの分子量を有 する、請求の範囲1もしくは2の組成物。 6.PEGもしくはその誘導体が約5,000ダルトンの分子量を有する、請求の範 囲1もしくは2の組成物。 7.タンパク質がEPOであり、そしてポリマーが約5,000ダルトンの分子量を 有するmPEGである、請求の範囲1の組成物。 8.水溶性ポリマーをポリペプチドのN末端のα−炭素原子に共有結合する方法 であって、 (a)ポリペプチドを、N末端のα−カルボニル基を有するアミノ基転移ポリペ プチドを形成するように、(i)約0.1Mから約2.0Mまでの濃度のグリオキシレー トイオンもしくはその誘導体、(ii)約10μMから約1Mまでの濃度の遷移金属 イオン、および(iii)約10mMから約10Mまでの濃度のルイス塩基と、約3.0から 約8.0までのpHおよび約0℃から約100℃までの温度で接触させること;そして (b)アミノ基転移ポリペプチドを、約1.0から約7.5までのpHで、アミノ基転 移ポリペプチドのN末端のα−カルボニル基と反応してヒドラゾン結合を形成す るそれに共有結合された部分を有する水溶性ポリマーと接触させ、それによりポ リマーをポリペプチドのN末端のα−炭素原子に共有結合させること、ただし、 ポリマーは約200から約200,000ダルトンまでの分子量を有し、また、ポリベプチ ドの本来の機能はそのN末端のα−アミノ基の除去により消去されないものであ る、 の段階を含んで成る方法。 9.水溶性ポリマーをポリペプチドのN末端のα−炭素原子に共有結合する方法 であって、 (a)ポリペプチドを、N末端のα−カルボニル基を有するアミノ基転移ポリペ プチドを形成するように、(i)約0.1Mから約2.0Mまでの濃度のグリオキシレー トイオンもしくはその誘導体、(ii)約10μMから約1Mまでの濃度の遷移金属 イオン、および(iii)約10mMから約10Mまで の濃度のルイス塩基と、約3.0から約8.0までのpHおよび約0℃から約100℃ま での温度で接触させること;そして (b)アミノ基転移ポリペプチドを、約1.0から約7.5までのpHで、アミノ基転 移ポリペプチドのN末端のα−カルボニル基と反応してオキシム結合を形成する それに共有結合された部分を有する水溶性ポリマーと接触させ、それによりポリ マーをポリペプチドのN末端のα−炭素原子に共有結合させること、ただし、ポ リマーは約200から約200,000ダルトンまでの分子量を有し、また、ポリペプチド の本来の機能はそのN末端のα−アミノ基の除去により消去されないものである 、 の段階を含んで成る方法。 10.段階(a)のpHが約5.0から約7.0までである、請求の範囲8もしくは9 の方法。 11.段階(b)のpHが約3.0から約5.0までである、請求の範囲8もしくは9 の方法。 12.タンパク質がEPOもしくはその誘導体である、請求の範囲8もしくは9 の方法。 13.ポリマーがPEGもしくはその誘導体である、請求の範囲8もしくは9の 方法。 14.PEGもしくはその誘導体が約700から約20,000ダルトンまでの分子量を 有する、請求の範囲13の方法。 15.PEGもしくはその誘導体が約5,000ダルトンの分子量を有する、請求の 範囲14の方法。 16.ポリマーに共有結合される部分がヒドラジンカルボキシレートである、請 求の範囲8の方法。 17.タンパク質がEPOであり、ポリマーが約5,000ダルトンの分子量を有す るmPEGであり、そしてポリマーに共有結合される部分がヒドラジンカルボキ シレートである、請求の範囲8の方法。 18.ポリマーに共有結合される部分がオキシルアミンである、請求の範囲9の 方法。 19.還元ヒドラゾン結合を形成するように、段階(b)で形成されたヒドラゾ ン結合を還元する段階をさらに含んで成る、請求の範囲8の方法。 20.還元オキシム結合を形成するように、段階(b)で形成されたオキシム結 合を還元する段階をさらに含んで成る、請求の範囲9の方法。 21.有効量の請求の範囲1もしくは2の組成物および製薬学的に許容できる担 体を含んで成る製薬学的組成物。 22.請求の範囲1の組成物の製造での使用のためのキットであって、以下すな わち (a)グリオキシレートイオンもしくはその誘導体; (b)遷移金属イオン; (c)ルイス塩基;および (d)約200から約200,000ダルトンまでの分子量を有し、かつ、アミノ基転移ポ リペプチドのN末端のα−カルボニル基と反応してヒドラゾン結合を形成し、そ れによりポリマーをポリペプチドのN末端のα−炭素原子に共有結合する、それ に共有結合された部分を有する水溶性ポリマー を含んで成るキット。 23.請求の範囲2の組成物の製造での使用のためのキットであって、 以下すなわち (a)グリオキシレートイオンもしくはその誘導体; (b)遷移金属イオン; (c)ルイス塩基;および (d)約200から約200,000ダルトンまでの分子量を有し、かつ、アミノ基転移ポ リペプチドのN末端のα−カルボニル基と反応してオキシム結合を形成し、それ によりポリマーをポリペプチドのN末端のα−炭素原子に共有結合する、それに 共有結合された部分を有する水溶性ポリマーを含んで成るキット。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US2305096P | 1996-08-02 | 1996-08-02 | |
US60/023,050 | 1996-08-02 | ||
PCT/US1997/013756 WO1998005363A2 (en) | 1996-08-02 | 1997-08-01 | Polypeptides having a single covalently bound n-terminal water-soluble polymer |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2000515553A true JP2000515553A (ja) | 2000-11-21 |
JP4410852B2 JP4410852B2 (ja) | 2010-02-03 |
Family
ID=21812842
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP50817398A Expired - Lifetime JP4410852B2 (ja) | 1996-08-02 | 1997-08-01 | 単一の共有結合n末端水溶性ポリマーを有するポリペプチド |
Country Status (19)
Country | Link |
---|---|
US (1) | US6077939A (ja) |
EP (2) | EP1731174A3 (ja) |
JP (1) | JP4410852B2 (ja) |
KR (1) | KR20000029673A (ja) |
CN (1) | CN100471521C (ja) |
AT (1) | ATE341344T1 (ja) |
AU (1) | AU3908597A (ja) |
BR (1) | BR9711009A (ja) |
CA (1) | CA2262994A1 (ja) |
DE (1) | DE69736780T2 (ja) |
DK (1) | DK0964702T3 (ja) |
ES (1) | ES2273373T3 (ja) |
IL (2) | IL128229A0 (ja) |
NO (1) | NO990465L (ja) |
NZ (1) | NZ333993A (ja) |
PT (1) | PT964702E (ja) |
RU (1) | RU2199347C2 (ja) |
SI (1) | SI0964702T1 (ja) |
WO (1) | WO1998005363A2 (ja) |
Cited By (1)
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DE69736780D1 (de) | 2006-11-16 |
EP1731174A2 (en) | 2006-12-13 |
DK0964702T3 (da) | 2007-01-08 |
IL128229A0 (en) | 1999-11-30 |
NO990465D0 (no) | 1999-02-01 |
AU3908597A (en) | 1998-02-25 |
PT964702E (pt) | 2006-12-29 |
SI0964702T1 (sl) | 2007-02-28 |
WO1998005363A2 (en) | 1998-02-12 |
NZ333993A (en) | 2000-01-28 |
NO990465L (no) | 1999-03-23 |
IL128229A (en) | 2007-07-04 |
EP0964702B1 (en) | 2006-10-04 |
RU2199347C2 (ru) | 2003-02-27 |
EP0964702A2 (en) | 1999-12-22 |
JP4410852B2 (ja) | 2010-02-03 |
CA2262994A1 (en) | 1998-02-12 |
CN100471521C (zh) | 2009-03-25 |
KR20000029673A (ko) | 2000-05-25 |
CN1226176A (zh) | 1999-08-18 |
US6077939A (en) | 2000-06-20 |
EP1731174A3 (en) | 2007-01-17 |
DE69736780T2 (de) | 2007-09-06 |
BR9711009A (pt) | 1999-08-17 |
WO1998005363A3 (en) | 1998-05-07 |
ES2273373T3 (es) | 2007-05-01 |
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