JP2005536992A - 哺乳動物のepo模倣ch1欠失ミメティボディ、組成物、方法および使用 - Google Patents
哺乳動物のepo模倣ch1欠失ミメティボディ、組成物、方法および使用 Download PDFInfo
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Abstract
Description
本発明は、生物学的に活性なタンパク質、フラグメントまたリガンドに特異的な哺乳動物のCH1欠失ミメティボディ、特定部分およびバリアント、CH1欠失ミメティボディをコードする核酸および相補的核酸、宿主細胞、および治療用製剤、投与およびデバイスを含むそれらの作成および使用法に関する。
組換えタンパク質は新興している治療薬の種類である。そのような組換え治療薬は、タンパク質製剤および化学的修飾を進歩させた。そのような修飾は、半減期を上昇させ(例えばタンパク質分解酵素に対してそれらの暴露を遮断することにより)、生物学的活性を強化し、または望ましくない副作用を減少させることによるように、治療用タンパク質の治療的用途を潜在的に強化することができる。1つのそのような修飾は、エンテラセプト(enteracept)のようなレセプタータンパク質に融合した免疫グロブリンフラグメントの使用である。また治療用タンパク質は、より長い半減期を提供するために、あるいはFc受容体結合、プロテインA結合および補体結合のような機能を包含するために、Fcドメインを使用して構築されてきた。
本発明は、当該技術分野で知られている事柄と組み合わせて、本明細書に記載し、かつ/または本明細書で可能となるような、修飾された免疫グロブリン、その開裂産物および他の特定部分およびバリアントを含む単離されたヒトのCH1欠失ミメティボディ、ならびにCH1欠失ミメティボディ組成物、コードまたは相補的核酸、ベクター、宿主細胞、組成物、製剤、デバイス、トランスジェニック動物、トランスジェニック植物、およびそれらの作成および使用法を提供する。
発明の説明
本発明は、単離された、組換えおよび/または合成のミメティボディまたは特定部分またはバリアント、ならびに少なくとも1つのCH1欠失ミメティボディをコードする少なくとも1つのポリヌクレオチドを含んでなる、組成物およびコード核酸分子を提供する。本発明のそのようなミメティボディまたは特定部分またはバリアントは、特異的なCH1欠失ミメティボディ配列、ドメイン、フラグメントおよびその特定部分、ならびに治療用組成物、方法およびデバイスを含む該核酸およびミメティボディまたは特定部分またはバリアントの作成および使用法も提供する。
用途
本発明の単離された核酸は、少なくとも1つのCH1欠失ミメティボディ、そのフラグメントまたは特定バリアントの生産に使用することができ、これは限定するわけではないが少なくとも1つの免疫障害もしくは疾患、心血管障害もしくは疾患、感染、悪性および/または神経障害もしくは疾患、貧血;免疫/自己免疫:および/またはガン/感染、ならびに他の既知の、または特定されたタンパク質関連状態から選択される少なくとも1つのタンパク質関連状態の症状をモジュレートし、処置し、緩和し、発生の防止を助け、または低減するために、細胞、組織、器官または動物(哺乳動物およびヒトを含む)で行うために使用できる。
引用
本明細書に引用するすべての刊行物または特許は全部、それらが本発明のこの時点の技術の状況を示し、かつ/または本発明の説明および可能性を提供するので参考により本明細書に編入する。刊行物とは任意の科学的もしくは特許公報、またはすべての記録された、電子的または印刷形式を含む任意の媒体形式で入手できる任意の他の情報を称する。以下の参考文献は引用により全部、本明細書に編入する:Ausubel,et al.編集、分子生物学の現在のプロトコール(Current Protocols in Molecular Biology)、ジョン ウィリー&サンズ社(John Wiley & Sons,Inc.)、ニューヨーク、ニューヨーク州(1987−2002):Sambrook,et al.、モレキュラークローニング:ア ラボラトリーマニュアル(Molecular Cloning:A Laboratory Manual)、第2版、コールドスプリングハーバー、ニューヨーク州(1989);Harlow and Lane、抗体(Antibodies)、ア ラボラトリーマニュアル、コールドスプリングハーバー、ニューヨーク州(1989);Colligan,et al.編集、免疫学の現在のプロトコール(Current Protocols in Immunology)、ジョン ウィリー&サンズ社、ニューヨーク州(1994−2002);Colligan,et al.,タンパク質科学の現在のプロトコール(Current Protocols in Protein Science)、ジョン ウィリー&サンズ社、ニューヨーク、ニューヨーク州、(1997−2002)。
本発明のミメティボディ
CH1欠失ミメティボディは任意選択により、少なくとも1つの可変抗体配列の少なくとも一部にさらに直接連結した少なくとも1つの治療用ペプチドに直接連結した任意選択のリンカー配列に直接連結した1つの部分的V領域に直接連結した少なくとも1つのヒンジ領域またはそのフラグメントに直接連結した少なくとも1つのCH2領域に直接連結した少なくとも1つのCH3領域を含んでなることができる。任意選択のN−末端抗体配列を含む1対のCH3−CH2−ヒンジ−部分的J配列−リンカー−治療用ペプチドの好適な態様では、この対は会合もしくは共有結合、例えば限定するわけではないがCys−Cysジスルフィド結合により任意に連結されている。すなわち本発明のCH1欠失ミメティボディは、その本来の特性および機能を持つ抗体構造を模すると同時に、治療用ペプチドおよびその本来の、または獲得したin vitro、in vivoまたはin situ特性または活性を提供する。本発明の少なくとも1つのCH1欠失ミメティボディの抗体の種々の部分および治療用ペプチド部分は、当該技術分野で知られている事柄と組み合わせて本明細書に記載するように変動させることができる。
を含んでなり、免疫グロブリン分子の種々の型、例えば限定するわけではないがIgG1、IgG2、IgG3、IgG4、IgA、IgM、IgD、IgE等またはそれらの組み合わせを模する。m=1である単量体は会合または共有結合、例えば限定するわけではないがCys−Cysジスルフィド結合により他の単量体と連結することができる。
核酸分子
少なくとも1つの配列番号1−1009ならびに抗体の少なくとも1つの部分の連続するアミノ酸の少なくとも90−100%をコードするヌクレオチド配列(ここで上記配列は式(I)のPep配列として挿入されて、本発明のCH1欠失ミメティボディを提供し、さらに特定のフラグメント、バリアントまたはそのコンセンサス配列を含んでなる)、またはこれらの配列の少なくとも1つを含んでなる寄託されたベクターのような本明細書に提供する情報を使用して、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントをコードする本発明の核酸分子は、本明細書に記載する方法または当該技術分野で知られているように得ることができる。
およびATCC寄託番号
でそれぞれ
に寄託された、
ような寄託されたプラスミドに含まれる核酸によりコードされるアミノ酸配列を有する(n)CH1欠失ミメティボディまたは特定部分またはバリアントをコードする単離された核酸分子を提供する。
本明細書に記載するポリヌクレオチドに選択的にハイブリダイズするポリヌクレオチド
本発明は選択的なハイブリダイゼーション条件下で、本明細書に開示するポリヌクレオチド、またはその特定バリアントもしくは部分を含む本明細書に開示する他のものとハイブリダイズする単離された核酸を提供する。すなわち本態様のポリヌクレオチドは、そのようなポリヌクレオチドを含んで成る核酸を単離し、検出し、かつ/または定量するために使用することができる。
核酸の構築
本発明の単離された核酸は、当該技術分野で周知な(a)組換え法、(b)合成技術、(c)精製技術、またはそれらの組み合わせを使用して作成することができる。
核酸を構築するための組換え法
RNA、cDNA、ゲノムDNAまたはそれらの任意の組み合わせのような本発明の単離された核酸組成物は、当業者に既知な多数のクローニング法を使用して生物起源から得ることができる。幾つかの態様では、cDNAまたはゲノムDNAライブラリー中の所望する配列を同定するために、適切なストリンジェンシー条件下で本発明のポリヌクレオチドと選択的にハイブリダイズするオリゴヌクレオチドプローブを使用する。RNAの単離、およびcDNAおよびゲノムライブラリーの構築は、当業者には周知である。(例えばAusubel、同上;またはSambrook、同上を参照にされたい)。
核酸分子を構築するための合成法
本発明の単離された核酸は、既知の方法で直接的な化学合成により調製することもできる(例えばAusubel et al.、同上を参照にされたい)。化学合成は一般に1本鎖オリゴヌクレオチドを生成し、これを相補的配列とのハイブリダイゼーションにより、または1本鎖を鋳型として使用したDNAポリメラーゼによる重合化により2本鎖DNAに転換することができる。当業者はDNAの化学合成は約100余りの塩基の配列に限定されるが、より長い配列は短い配列の連結により得ることができると認識するだろう。
組換え発現カセット
本発明はさらに、本発明の核酸を含んでなる組換え発現カセットを提供する。本発明の核酸配列、例えば本発明のCH1欠失ミメティボディまたは特定部分またはバリアントをコードするcDNAまたはゲノム配列は、少なくとも1つの所望する宿主細胞に導入することができる組換え発現カセットを構築するために使用することができる。組換え発現カセットは典型的には、意図する宿主細胞でポリヌクレオチドの転写を支配する転写開始調節配列に操作可能に連結された本発明のポリヌクレオチドを含んでなる。ヘテロロガスおよび非ヘテロロガス(すなわち内因性)の両方のプロモーターを使用して、本発明の核酸の発現を支配することができる。
ベクターおよび宿主細胞
本発明は、本発明の単離された核酸分子を含むベクター、組換えベクターにより遺伝的に操作された宿主細胞、および当該技術分野で周知な組換え法による少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントの生産に関する。例えばSambrook,et al.、同上;Ausubel et al.、同上(各々、引用により全部、本明細書に編入する)を参照にされたい。
CH1欠失ミメティボディまたはその特定部分またはバリアントの精製
CH1欠失ミメティボディまたは特定部分またはバリアントは、限定するわけではないがプロテインA精製、硫酸アンモニウムもしくはエタノール沈殿、酸抽出、アニオンもしくはカチオン交換クロマトグラフィー、ホスホセルロースクロマトグラフィー、疎水性相互作用クロマトグラフィー、アフィニティクロマトグラフィー、ハイドロキシルアパタイトクロマトグラフィーおよびレクチンクロマトグラフィーを含む周知な方法により、組換え細胞培養から回収し、そして精製することができる。高性能液体クロマトグラフィー(“HPLC”)も精製に使用することができる。例えばColligan、免疫学における現在のプロトコール、またはタンパク質科学における現在のプロトコール、ジョン ウィリー & サンズ、ニューヨーク、ニューヨーク州(1997−2002)、例えば第1、4、6、8、9、10章を参照にされたい(各々が全部、引用により本明細書に編入される)。
ミメティボディ、特定フラグメントおよび/またはバリアント
本発明の単離されたミメティボディは、本明細書でさらに完全に検討する本発明の1つのポリヌクレオチドによりコードされるCH1欠失ミメティボディまたは特定部分またはバリアント、あるいは任意の単離もしくは調製されたCH1欠失ミメティボディまたはその特定部分またはバリアントを含んでなる。
アミノ酸暗号
本発明のミメティボディまたは特定部分またはバリアントを作るアミノ酸は、しばしば略記される。アミノ酸の命名法は当該技術分野で周知であるように、その1文字暗号、その3文字暗号、名前または3ヌクレオチドコドン(1つまたは複数)によるアミノ酸の命名により示すことができる(Alberts,B.,et al.,細胞の分子生物学(Molecular Biology of The Cell)、第3版、ガーランド(Garland)出版社、ニューヨーク、1994を参照にされたい):
CH1欠失ミメティボディ組成物
また本発明は、自然には存在しない組成物、混合物または形態で提供される、本明細書に記載し、かつ/または当該技術分野で既知であるような少なくとも1つの、少なくとも2つの、少なくとも3つの、少なくとも4つの、少なくとも5つの、少なくとも6以上のミメティボディまたはその特定部分またはバリアントを含んで成る、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアント組成物を提供する。そのような組成物の割合は、当該技術分野で既知の、または本明細書に記載するような液体もしくは乾燥溶液、混合物、懸濁液、乳液またはコロイドとしての重量、容量、濃度、容量モル濃度または重量モル濃度による。そのような組成物の割合は、限定するわけではないが0.00001、0.00003、0.00005、0.00009、0.0001、0.0003、0.0005、0.0009、0.001、0.003、0.005、0.009、0.01、0.02、0.03、0.05、0.09、0.1、0.2、0.3、0.4、0.5、0.6、0.7、0.8、0.9、1.0、1.1、1.2、1.3、1.4、1.5、1.6、1.7、1.8、1.9、2.0、2.1、2.2、2.3、2.4、2.5、2.6、2.7、2.8、2.9、3.0、3.1、3.2、3.3、3.4、3.5、3.6、3.7、3.8、3.9、4.0、4.3、4.5、4.6、4.7、4.8、4.9、5、6、7、8、9、10、15、20、25、30、35、40、45、50、55、60、65、70、71、72、73、74、75、76、77、78、79、80、81、82、83、84、85、86、87、88、89、90、91、92、93、94、95、96、97、98、99、99.1、99.2、99.3、99.4、99.5、99.6、99.7、99.8、99.9%のような、当該技術分野で既知の、または本明細書に記載するような液体、ガスもしくは乾燥溶液、混合物、懸濁液、乳液またはコロイドとしての重量、容量、濃度、容量モル濃度またはモル重量濃度で0.00001〜99.9999パーセントを含んでなることができる。本発明のそのような組成物は、このように限定するわけではないが0.00001〜100mg/mlおよび/または0.00001〜100mg/gを含む。
少なくとも1つの筋収縮薬は乳酸アムリノン、ジゴキシン、乳酸ミルリノンから選択される少なくとも1つであることができる。少なくとも1つの抗不整脈薬はアデノシン、塩酸アミオダロン、硫酸アトロピン、ブレチリウムトシラート、塩酸ジルチアゼム、ジソピラミド、リン酸ジソピラミド、塩酸エスモロール、酢酸フレカイニド、フマル酸イブチリド(ibutilide)、塩酸リドカイン、塩酸メキシレチン、塩酸モリシジン(moricizine)、フェニトイン、フェニトインナトリウム、塩酸プロカインアミド、塩酸プロパフェノン、塩酸プロプラノロール(propranolol)、重硫酸キニジンビ、グルコン酸キニジン、ポリガラクツロン酸キニジン、硫酸キニジン、ソタロール、塩酸トカイニド、塩酸ベラパミルから選択される少なくとも1つであることができる。少なくとも1つの抗狭心症薬は、アムロジピジン(amlodipidine)ベシレート、アミルニトリット、塩酸ベプリジル(bepridil)、塩酸ジルチアゼム、イソソルビドジニトレート、イソソルビドモノニトレート、ナドロール、塩酸ニカルジピン、ニフェジピン、ニトログリセリン、塩酸プロパノロール、ベラパミル、塩酸ベラパミルから選択される少なくとも1つであることができる。少なくとも1つの抗高血圧症薬は、塩酸アセブトロール、アムロジピンベシレート、アテノロール、塩酸ベナゼプリル(benazepril)、塩酸ベタキソロール、フマル酸ビソプロロール(bisoprolol)、カンデサルタン シレキセチル(candesartan cilexetil)、カプトプリル、塩酸カルテオロール(carteolol)、カルベディロール、クロニジン、塩酸クロニジン、ジアゾキシド、塩酸ジルチアゼム、メシル酸ドキサゾシン、エナラプリラート、マレイン酸エナラプリル、メシル酸エプロサルタン(eprosartan)、フェロジピン、メシル酸フェノルドパム(fenoldopam)、フォシノプリル(fosinopril)ナトリウム、酢酸グアナベンズ、硫酸グアナドレル、塩酸グアンファシン、塩酸ヒドララジン、イルベサルタン(irbesartan)、イスラジピン(isradipine)、塩酸ラベタロール、リジノプリル、ロサルタン(losartan)カリウム、メチルドパ、塩酸メチルドペート、コハク酸メトプロロール、酒石酸メトプロロール、ミノキシジル、塩酸モエキシプリル(moexipril)、ナドロール、塩酸ニカルジピン、ニフェジピン、ニソルジピン、ニトロプルシドナトリウム、硫酸ペンブトロール(penbutolol)、ペリンドプリル エルブミン(perindopril erbumine)、メシル酸フェントラミン、ピンドロール、塩酸プラゾシン、塩酸プロパノロール、塩酸キナプリル、ラミプリル(ramipril)、テルミサルタン(telmisartan)、塩酸テラゾシン、マレイン酸チモロール、トランドラプリル(trandolapril)、バルサルタン(valsartan)、塩酸ベラパミルから選択される少なくとも1つであることができる。少なくとも1つの抗高脂血症薬は、アトルバスタチン(atorvastatin)カルシウム、セリバスタチン(cerivastatin)ナトリウム、コレスチラミン、塩酸コレスチポール、フェノフィブレート(fenofibrate)(微結晶化)、フルバスタチン(fluvastatin)ナトリウム、ゲムフィブロジル、ロバスタチン、ナイアシン、プラバスタチンナトリウム、シンバスタチンから選択される少なくとも1つであることができる。少なくとも1つの他方面のCV薬はアブシキシマブ、アルプロスタジル、塩酸アルブタミン(arbutamine)、シロスタゾル(cilostazol)、重硫酸クロピドグレル(clopidogrel)、ジピリダモール、エプチフィバチド(eptifibatide)、塩酸ミドドリン(midodrine)、ペントキシフィリン(pentoxifylline)、塩酸チクロピジン(ticlopidine)、塩酸チロフィバン(tirofiban)から選択される少なくとも1つであることができる(例えばナーシング 2001 ドラッグハンドブックの第215〜336頁を参照にされたい。)
少なくとも1つの非麻酔性鎮痛薬または解熱薬は、アセトアミノフェン、アスピリン、トリサリチル酸マグネシウムコリン、ジフルニサル、サリチル酸マグネシウムから選択される少なくとも1つであることができる。少なくとも1つの非ステロイド系抗炎症薬は、セレコキシブ(celecoxib)、ジクロフェナクカリウム、ジクロフェナクナトリウム、エトドラク(etodolac)、フェノプロフェンカルシウム、フルビプロフェン(flubiprofen)、イブプロフェン、インドメタシン、インドメタシンナトリウム三水和物、ケトプロフェン、ケトロラクトロメタミン、ナブメトン(nabumetone)、ナプロキセン、ナプロキセンナトリウム、オキサプロジン(oxaprozin)、ピロキシカム、ロフェコキシブ(rofecoxib)、スリンダクから選択される少なくとも1つであることができる。少なくとも1つの麻酔性またはオピオイド系鎮痛薬は、塩酸アルフェンタニル、塩酸ブプレノルフィン、酒石酸ブトルファノール、リン酸コデイン、硫酸コデイン、クエン酸フェンタニル、フェンタニル経皮系、フェンタニル経粘膜系、塩酸ヒドロモルホン、塩酸メペリジン、塩酸メタドン、塩酸モルフィン、硫酸モルフィン、酒石酸モルフィン、塩酸ナルブフィン、塩酸オキシコドン、ペクチン酸オキシコドン、塩酸オキシモルフォン、塩酸ペンタゾシン、塩酸ペンタゾシンおよび塩酸ナロキソン、乳酸ペンタゾシン、塩酸プロポキシフェン、プロポキシフェンナプシレート、塩酸レミフェンタニル(remifentanil)、クエン酸サフェンタニル、塩酸トラマドールから選択される少なくとも1つであることができる。少なくとも1つの鎮痛−睡眠薬はクラロール水和物、エスタゾラム、塩酸フルラゼパム、ペントバルビタール、ペントバルビタールナトリウム、フェノバルビタールナトリウム、セコバルビタールナトリウム、テマゼパム、トリアゾラム、ザレプロン(zaleplon)、酒石酸ゾルピデムから選択される少なくとも1つであることができる。少なくとも1つの鎮痙剤は、アセタゾルアミドナトリウム、カルバマゼピン、クロナゼパム、ジカリウムクロラゼペート、ジアゼパム、ジバルプロックスナトリウム、エトスクシミド、ホスフェニトインナトリウム、ガバペンチン、ラモトリジン、硫酸マグネシウム、フェノバルビタール、フェノバルビタールナトリウム、フェニトイン、フェニトインナトリウム、フェニトインナトリウム(増量:extended)、プリミドン、塩酸チアガビン(tiagabine)、トピラメート(topiramate)、バルプロ酸ナトリウム、バルプロ酸から選択される少なくとも1つであることができる。少なくとも1つの抗鬱薬は、塩酸アミトリプチリン、パモ酸アミトリプチリン、アモキサピン(amoxapine)、塩酸ブプロピオン、臭化水素酸シタロプラム(citalopram)、塩酸クロミプラミン、塩酸デシプラミン、塩酸ドキセピン、塩酸フルオキセチン、塩酸イミプラミン、パモ酸イミプラミン、ミルタザピン(mirtazapine)、塩酸ネファゾドン(nefazodone)、塩酸ノルトリプチリン、塩酸パロキセチン、硫酸フェネルジン、塩酸セルトラリン(sertraline)、硫酸トラニルシプロミン、マレイン酸トリミプラミン、塩酸ベンラファキシン(venlafaxine)から選択される少なくとも1つであることができる。少なくとも1つの抗不安薬は、アルプラゾラム(alprazolam)、塩酸ブスピロン(buspirone)、クロルジアゼポキシド、塩酸クロルジアゼポキシド、ジカリウムクロラゼペート(clorazepate)、ジアゼパム、塩酸ドキセピン、ヒドロキシジンエンボネート、塩酸ヒドロキシジン、パモ酸ヒドロキシジン、ロラゼパム(lorazepam)、メフロバメート(mephrobamate)、塩酸ミダゾラム(midazolam)、オキサゼパムから選択される少なくとも1つであることができる。少なくとも1つの抗精神薬は、塩酸クロルプロマジン、クロザピン、フルフェナジンデカノエート、フルフェナジンエナンテート、塩酸フルフェナジン、フルフェナジン、ハロペリドール、デカン酸ハロペリドール、乳酸ハロペリドール、塩酸ロキサピン、コハク酸ロキサピン、メソリダジンベシレート(mesoridazine besylate)、塩酸モリンドン(molindone)、オランザピン(olanzapine)、ペルフェナジン、ピモジド(pimozide)、プロクロルペラジン(prochlorperazine)、フマル酸クェチアピン(quetiapine)、リスペリドン(risperidone)、塩酸チオリダジン、チオチキセン,塩酸チオチキセン、塩酸トリフルオペラジンから選択される少なくとも1つであることができる。少なくとも1つの中枢神経系刺激物は、硫酸アンフェタミン、カフェイン、硫酸デキストロアンフェタミン、塩酸ドキサプラム、塩酸メタンフェタミン、塩酸メチルフェニデート、モダフィニル、ペモリン、塩酸フェンテルミンから選択される少なくとも1つであることができる。少なくとも1つの抗パーキンソン病薬は、塩酸アマンタジン、メシル酸ベンズトロフィン、塩酸ビペリデン、乳酸ビペリデン、メシル酸ブロモクリプチン、カルビドパ−レボドパ、エンタカポン(entacapone)、レボドパ、メシル酸ペルゴリド(pergolide)、プラミペキソールジヒドロクロライド、塩酸ロピニロール(ropinirol)、塩酸セレジリン、トルカポン(tolcapone)、塩酸トリヘキシフェニジルから選択される少なくとも1つであることができる。少なくとも1つの他方面の中枢神経系薬は、塩酸ブプロピオン、塩酸ドネペジル(donepezil)、ドロペリドール、マレイン酸フルボキサミン(fluvoxamine)、炭酸リチウム、クエン酸リチウム、塩酸ナラトリプタン(naratriptan)、ニコチンポラクリレクス(polacrilex)、ニコチン経皮系、プロポホル(propofol)、安息香酸リザトリプタン(rizatriptan)、塩酸シブトラミン(sibutramine)一水和物、コハク酸スマトリプタン(sumatriptan)、塩酸タクリン、ゾルミトリプタン(zolmitriptan)から選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第337〜530頁を参照にされたい。)
少なくとも1つのコリン作用薬(例えば副交感神経作用薬)は、塩化ベタニコール、塩化エドロホニウム、臭化ネオスチグミン、メチル硫酸ネオスチグミン、サリチル酸フィソスチグミン、臭化ピリドスチグミンから選択される少なくとも1つであることができる。少なくとも1つの抗コリン作用薬は、硫酸アトロピン、塩酸ジシクロミン、グリコピロレート(glycopyrrolate)、ヒヨスチアミン、硫酸ヒヨスチアミン、臭化プロパンセリン(propantheline)、スコポラミン、スコポラミンブチルブロミド、スコポラミンヒドロブロミドから選択される少なくとも1つであることができる。少なくとも1つのアドレナリン作用薬(交感神経作用薬)は、塩酸ドブタミン(dobutamine)、塩酸ドーパミン、重酒石酸メタラミノール、重酒石酸ノルエピネフリン、塩酸フェニレフリン、塩酸プソイドエフェドリン、硫酸プソイドエフェドリンから選択される少なくとも1つであることができる。少なくとも1つのアドレナリン遮断薬(交感神経遮断薬)は、メシル酸ジヒドロエルゴタミン、酒石酸エルゴタミン、マレイン酸メチセルジド、塩酸プロパラノールから選択される少なくとも1つであることができる。少なくとも1つの筋弛緩剤は、バクロフェン、カリソプロドール、クロルゾキサゾン、塩酸シクロベンザプリン、ダントロレンナトリウム、メトカルバモール、塩酸チザニジン(tizanidine)から選択される少なくとも1つであることができる。少なくとも1つの神経筋遮断薬はアトラクリウムベシレート、シスアトラクリウムベシレート、塩化ドキサクリウム、塩化ミバクリウム、臭化パンクロニウム、臭化ピペクロニウム、臭化ラパクロニウム、臭化ロクロニウム、塩化スクシニルコリン、塩化ツボクラリン、臭化ベクロニウムから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第531〜84頁を参照されたい。)
少なくとも1つの抗ヒスタミン薬は、マレイン酸ブロモフェニラミン、塩酸セチリジン(cetirizine)、マレイン酸クロロフェニラミン、フマル酸クレマスチン、塩酸シプトヘプタジン、塩酸ジフェンヒドラミン、塩酸フェキソフェナジン(fexofenadine)、ロラタジン(loratadine)、塩酸プロメタジン、プロメタジンテオクレート(theoclate)、塩酸トリプロリジンから選択される少なくとも1つであることができる。少なくとも1つの気管支拡張薬は、アルブテロール、硫酸アルブテロール、アミノフィリン、硫酸アトロピン、硫酸エフェドリン、エピネフリン、重酒石酸エピネフリン、塩酸エピネフリン、臭化イプラトロピウム、イソプロテレノール、塩酸イソプロテレノール、硫酸イソプロテレノール、塩酸レバルブテロール(levalbuterol)、硫酸メタプロテレノール、オキシトリフィリン、酢酸ピルブテロール、ザルメテロール キシナフエート(salmeterol xinafoate)、硫酸テルブタリン、テオフィリンから選択される少なくとも1つであることができる。少なくとも1つの去痰薬または鎮咳薬は、ベンゾナテート、リン酸コデイン、硫酸コデイン、デキストラメトロファン(dextramethorphan)ヒドロブロミド、塩酸ジフェンヒドラミン、グアイフェネシン、塩酸ヒドロモルホンから選択される少なくとも1つであることができる。少なくとも1つの他方面の呼吸薬は、アセチルシステイン、ベクロメタゾン ジプロピオネート、ベラクタント(beractant)、ブデソニド(budesonide)、カルファクタント(calfactant)、クロモリンナトリウム、ドルナーゼ(dornase)アルファ、エポプロステノールナトリウム、フルニソリド、プロピオン酸フルチカゾン(fluticasone)、モンテルカストナトリウム、ネドクロミル(nedocromil)ナトリウム、パリビズマブ(palivizumab)、トリアムシノロンアセトニド、ザフィルルーカスト、ジロウトン(zileuton)から選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第585〜642頁を参照されたい。)
少なくとも1つの制酸薬、吸着薬または抗発張薬は、炭酸アルミニウム、水酸化アルミニウム、炭酸カルシウム、マガルドレート、水酸化マグネシウム、酸化マグネシウム、シメチコーン、重炭酸ナトリウムから選択される少なくとも1つであることができる。少なくとも1つの消化酵素または胆石溶解薬は、パンクレアチン、パンクレリパーゼ、ウルソジオール(ursodiol)から選択される少なくとも1つであることができる。少なくとも1つの止瀉薬はアタパルジャイト、次サリチル酸ビスマス、ポリカルボフィルカルシウム、塩酸ジフェノキシレートもしくは硫酸アトロピン、ロペラミド、酢酸オクトレオチド(octreotide)、オピウムチンキ、オピウムチンキ(樟脳処理)から選択される少なくとも1つであることができる。少なくとも1つの緩下薬は、ビソコジル(bisocodyl)、ポリカルボフィルカルシウム、カスカラサグラダ、カスカラサグラダ芳香性流エキス剤、カスカラサグラダ流エキス剤、ひまし油、ドキュセートカルシウム、ドキュセートナトリウム、グリセリン、ラクチュロース、クエン酸マグネシウム、水酸化マグネシウム、硫酸マグネシウム、メチルセルロース、鉱物油、ポリエチレングリコールもしくは電解質溶液、車前子(psyllium)、センナ、リン酸ナトリウムから選択される少なくとも1つであることができる。少なくとも1つの制吐薬は、塩酸クロルプロマジン、ジメンヒドリネート、メシル酸ドラセトロン(dolasetron)、ドロナビノール、塩酸グラニセトロン(granisetron)、塩酸メクリジン、塩酸メトクロプラミド、塩酸オンダンセトロン、ペルフェナジン、プロクロルペラジン、プロクロルペラジンエジシレート(edisylate)、マレイン酸プロクロルペラジン、塩酸プロメタジン、スコポラミン、マレイン酸チエチルペラジン、塩酸トリメトベンザミドから選択される少なくとも1つであることができる。少なくとも1つの抗潰瘍薬は、シメチジン、塩酸シメチジン、ファモチジン、ランソプラゾール(lansoprazole)、ミソプロストール、ニザチジン、オメプラゾール、ラベプラゾールナトリウム、クエン酸ランチジン(rantidine)ビスマス、塩酸ラニチジン、スクラルフェートから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第645〜95頁を参照されたい。)
少なくとも1つのコルチコステロイドはベタメタゾン、酢酸ベタメタゾンまたはリン酸ナトリウムベタメタゾン、リン酸ナトリウムベタメタゾン、酢酸コルチゾン、デキサメタゾン、酢酸デキサメタゾン、リン酸ナトリウムデキサメタゾン、酢酸フルドロコルチゾン、ヒドロコルチゾン、酢酸ヒドロコルチゾン、ヒドロコルチゾンシピオネート、リン酸ナトリウムヒドロコルチゾン、コハク酸ナトリウムヒドロコルチゾン、メチルプレドニゾロン、酢酸メチルプレドニゾロン、コハク酸ナトリウムメチルプレドニゾロン、プレドニゾロン、酢酸プレドニゾロン、リン酸ナトリウムプレドニゾロン、プレドニゾロンテブテート、プレドニゾン、トリアムシノロン、トリアムシノロンアセテート、トリアムシノロンジアセテートから選択される少なくとも1つであることができる。少なくとも1つのアンドロゲンまたは同化性ステロイドは、ダナゾール、フルオキシメステロン、メチルテストステロン、ナンドロロンデカノエート、ナンドロロンフェンプロピオネート、テストステロン、テストステロンシピオネート、テストステロンエナンタート、テストステロンプロピオネート、テストステロン経皮系から選択される少なくとも1つであることができる。少なくとも1つのエストロゲンまたはプロゲスチンは、エステル化エストロゲン、エストラジオール、エストラジオールシピオネート、エストラジオール/酢酸ノルエチンドロン経皮系、吉草酸エストラジオール、エストロゲン(共役)、エストロピペート(estropipate)、エチニルエストラジオール、エチニルエストラジオールおよびデソゲストレル(desogestrel)、エチニルエストラジオールおよびエチノジオールジアセテート、エチニルエストラジオールおよびデソゲストレル、エチニルエストラジオールおよびエチノジオールジアセテート、エチニルエストラジオールおよびレボノルゲストレル(levonorgestrel)、エチニルエストラジオールおよびノルエチンドロン、エチニルエストラジオールおよび酢酸ノルエチンドロン、エチニルエストラジオールおよびノルゲスチメート(norgestimate)、エチニルエストラジオールおよびノルゲストレル、エチニルエストラジオールおよびノルエチンドロンおよびアセテートおよびフマル酸鉄、レボノルゲストレル、酢酸メドロキシプロゲステロン、メストラノールおよびノルエチンドロン、ノルエチンドロン、酢酸ノルエチンドロン、ノルゲストレル、プロゲステロンから選択される少なくとも1つであることができる。少なくとも1つのゴナドトロピンは、酢酸ガニレリックス、酢酸ゴナドレリン、酢酸ヒストレリン(histrelin)、メノトロピンから選択される少なくとも1つであることができる。少なくとも1つの抗糖尿病薬またはグルカオンはアカルボース、クロロプロパミド、グリメピリド(glimepiride)、グリピジド(glipizide)、グルカゴン、グリブリド、インスリン、塩酸メトホルミン、ミグリトール(miglitol)、塩酸ピオグリタゾン(pioglitazone)、レパグリニド(repaglinide)、マレイン酸ロシグリタゾン(rosiglitazone)、トログリタゾンから選択される少なくとも1つであることができる。少なくとも1つの甲状腺ホルモンは、レボチロキシン(levothyroxine)ナトリウム、リオチロニン(liothyronine)ナトリウム、リオトリックス(liotrix)、チロイド(thyroid)から選択される少なくとも1つであることができる。少なくとも1つの甲状腺ホルモンアンタゴニストは、メチマゾール、ヨウ化カリウム、ヨウ化カリウム(飽和溶液)、プロピルチオウラシル、放射性ヨウ素(ヨウ化ナトリウム131I)、強いヨウ素溶液から選択される少なくとも1つであることができる。少なくとも1つの下垂体ホルモンは、コルチコトロピン、コシントロピン、酢酸デスモプレシン、酢酸ロイプロリド、呼吸コルチコトロピン、ソマトレム、ソマトロピン、バソプレッシンから選択される少なくとも1つであることができる。少なくとも1つの副甲状腺様薬は、カルシフェジオール(calcifediol)、カルシトニン(ヒト)、カルシトニン(サケ)、カルシトルオール、ジヒドロタキステロール(dihydrotachysterol)、エチドロネート二ナトリウムから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第696〜796頁を参照されたい。)
少なくとも1つの利尿剤は、アセタゾルアミド、アセタゾルアミドナトリウム、塩酸アミロライド、ブメタニド(bumetanide)、クロルサリドン、エタクリネートナトリウム、エタクリン酸、フロセミド、ヒドロクロロチアジド、インダパミド(indapamide)、マンニトール、メトラゾン、スピロノラクトン、トルセミド(torsemide)、トリアムテレン、尿素から選択される少なくとも1つであることができる。少なくとも1つの電解質または代替溶液は、酢酸カルシウム、炭酸カルシウム、塩化カルシウム、クエン酸カルシウム、カルシウムグルビオネート、カルシウムグルセプテート、グルコン酸カルシウム、乳酸カルシウム、リン酸カルシウム(二塩基性)、リン酸カルシウム(三塩基性)、ゼキストラン(高分子量)、デキストラン(低分子量)、ヘタスターチ、塩化マグネシウム、硫酸マグネシウム、酢酸カリウム、重炭酸カリウム、塩化カリウム、グコン酸カリウム、リンゲル注入液、リンゲル注入液(乳酸化)、塩化ナトリウムから選択される少なくとも1つであることができる。少なくとも1つの酸性化剤またはアルカリ性化剤は、重炭酸ナトリウム、乳酸ナトリウム、トロメタミンから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第797〜833頁を参照されたい。)
少なくとも1つの造血薬は、フマル酸鉄、グルコン酸鉄、硫酸鉄、硫酸鉄(乾燥化)、デキストラン鉄、ソルビトール鉄、多糖−鉄錯体、グルコン酸鉄ナトリウム錯体から選択される少なくとも1つであることができる。少なくとも1つの抗凝固薬は、アルデパリン(ardeparin)ナトリウム、ダルテパリン(dalteparin)ナトリウム、ダナパロイド(danaparoid)ナトリウム、エノキサパリン(enoxaparin)ナトリウム、ヘパリンカルシウム、ヘパリンナトリウム、ワルファリンナトリウムから選択される少なくとも1つであることができる。少なくとも1つの血液誘導体は、アルブミン5%、アルブミン25%、抗血友病因子、抗−インヒビター凝固複合体、アンチトロンビンIII(ヒト)、第IX因子(ヒト)、第IX因子複合体、血漿タンパク質画分から選択される少なくとも1つであることができる。少なくとも1つの血栓溶解酵素はアルテプラーゼ(alteplase)、アニストレプラーゼ(anistreplase)、レテプラーゼ(reteplase)(組換え)、ストレプトキナーゼ、ウロキナーゼから選択される少なくとも1つであることができる。(例えばナーシング 2001ドラッグハンドブックの第834〜66頁を参照されたい。)
少なくとも1つのアルキル化剤は、ブスルファン、カルボプラチン、カルムスチン、クロラムブシル、シスプラチン、シクロフォスファミド、イフォスファミド(ifosfamide)、ロムスチン、塩酸メクロレタミン、メルファラン、塩酸メルファラン、ストレプトゾシン、テモゾロミド、チオテパから選択される少なくとも1つであることができる。少なくとも1つの代謝拮抗物質は、カペシタビン(capecitabine)、クラドリビン(cladribine)、シタラビン、フロクスウリジン、リン酸フルダラビン(fludarabine)、フルオロウラシル、ヒドロキシウレア、メルカプトプリン、メトトレキセート、メトトレキセートナトリウム、チオグアニンから選択される少なくとも1つであることができる。少なくとも1つの抗生物質系抗腫瘍薬は、硫酸ブレオマイシン、ダクチノマイシン、クエン酸ダウノルビシンリポソーム、塩酸ダウノルビシン、塩酸ドキソルビシン、塩酸ドキソルビシンリポソーム、塩酸エピルビシン(epirubicine)、塩酸イダルビシン(idarubicin)、マイトマイシン、ペントスタチン、プリカマイシン、バルルビシン(valrubicin)から選択される少なくとも1つであることができる。ホルモンバランスを改変する少なくとも1つの抗腫瘍薬は、アナストロゾール(anastrozole)、ビカルタミド(bicalutamide)、エストラムスチンリン酸ナトリウム、エグゼメスタン(exemestane)、フルタミド(flutamide)、酢酸ゴセレリン、レトロゾール(letrozole)、酢酸ロイプロリド、酢酸メゲストロール、ニルタミド(nilutamide)、クエン酸タモキシフェン、テストラクトン、クエン酸トレミフェン(toremifene)から選択される少なくとも1つであることができる。少なくとも1つの他方面の抗腫瘍薬は、アスパラギナーゼ、桿菌カルメット−ゲラン(BCG)(生嚢内)、ダカルバジン、ドセタキセル、エトポシド、リン酸エトポシド、塩酸ジェムシタビン(gemcitabine)、塩酸イリノテカン(irinotecan)、ミトーテン、塩酸ミトザントロン、パクリタキセル、ペガスパルガーゼ(pegaspargase)、ポルフィマー(porfimer)ナトリウム、塩酸プロカルバジン、リタキシマブ、テニポシド、塩酸トポテカン、トラスツズマブ(trastuzumab)、トレチノイン、硫酸ビンブラスチン、硫酸ビンクリスチン、酒石酸ビノレルビン(vinorelbine)から選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第867〜963頁を参照されたい。)
少なくとも1つの免疫抑制剤は、アザチオプリン、バシリキシマブ(basiliximab)、シクロスポリン、ダクリズマブ(daclizumab)、リンパ球免疫グロブリン、マウス−モノクローナル抗体CD3、マイコフェノレート モフェチル(mycophenolate mofetil)、塩酸マイコフェノレート モフェチル、シロリムス(sirolimus)、タクロリムス(tacrolimus)から選択される少なくとも1つであることができる。少なくとも1つのワクチンまたは毒素は、BCGワクチン、コレラワクチン、ジフテリアおよび破傷風毒素(吸着)、ジフテリアおよび破傷風毒素および無細胞百日咳ワクチン(吸着)、ジフテリアおよび破傷風毒素および全細胞百日咳ワクチン、ヘモフィルス(Haemophilius)b共役ワクチン、A型肝炎ワクチン(不活化)、B型肝炎ワクチン(組換え)、インフルエンザウイルスワクチン1999−2000三価型A&B(精製表面抗原)、インフルエンザウイルスワクチン1999−2000三価型A&B(サブビリオンまたは精製ビリオン)、インフルエンザウイルスワクチン1999−2000三価型A&B(全ビリオン)、日本脳炎ウイルスワクチン(不活化)、ライム病ワクチン(組換えOspA)、麻疹およびムンプスおよび風疹ウイルスワクチン(生)、麻疹およびムンプスおよび風疹ウイルスワクチン(弱毒化生)、麻疹ウイルスワクチン(弱毒化生)、髄膜炎菌多糖ワクチン、ムンプスウイルスワクチン(生)、悪疫ワクチン、肺炎球菌ワクチン(多価)、ポリオウイルスワクチン(不活化)、ポリオウイルスワクチン(生、経口、三価)、狂犬病ワクチン(吸着)、狂犬病ワクチン(ヒト二倍体細胞)、風疹およびムンプスウイルスワクチン(生)、風疹ウイルスワクチン(弱毒化生)、破傷風毒素(吸着)、破傷風毒素(流体)、チフスワクチン(経口)、チフスワクチン(非経口)、チフスVi多糖ワクチン、水痘ウイルスワクチン、黄熱病ワクチンから選択される少なくとも1つであることがである。少なくとも1つの抗毒素はまたは抗蛇毒素は、クロゴケグモ抗毒素、ガラガラヘビ科の抗蛇毒素(多価)、ジフテリア抗毒素(ウマ)、Micrurus fulvius抗蛇毒素から選択される少なくとも1つであることがである。少なくとも1つの免疫血清はサイトメガロウイルス免疫グロブリン(静脈内)、B型肝炎免疫グロブリン(ヒト)、免疫グロブリン筋肉内、免疫グロブリン静脈内、狂犬病免疫グロブリン(ヒト)、呼吸合胞体ウイルス免疫グロブリン静脈内(ヒト)、Rh0(D)免疫グロブリン(ヒト)、Rh0(D)免疫グロブリン静脈内(ヒト)、破傷風免疫グロブリン(ヒト)、水痘−帯状疱疹免疫グロブリンから選択される少なくとも1つであることがである。少なくとも1つの生物学的応答モディファイヤーは、アルデスロイキン(aldesleukin)、エポエチン アルファ、フィルグラスチム、注射用の酢酸グラチラマー(glatiramer)、インターフェロン アルファコン−1、インターフェロン アルファ−2a(組換え)、インターフェロン アルファ−2b(組換え)、インターフェロン ベータ−1a、インターフェロン ベータ−1b(組換え)、インターフェロン ガンマ−1b、塩酸レバミソール、オプレルベキン(oprelvekin)、サルグラモスチンから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第964〜1040頁を参照されたい。)
少なくとも1つの目の抗感染薬は、バシトラシン、クロラムフェニコール、塩酸シプロフロキサシン、エリスロマイシン、硫酸ゲンタマイシン、オフロキサシン0.3%、硫酸ポリミキシンB、スルファタミドナトリウム10%、スルファタミドナトリウム15%、スルファタミドナトリウム30%、トブラマイシン、ビダラビンから選択される少なくとも1つであることができる。少なくとも1つの目の抗炎症薬は、デキサメタゾン、リン酸ナトリウムデキサメタゾン、ジクロフェナクナトリウム0.1%、フルオロメトロン、フルルビプフェンナトリウム、ケトロラク トロメタミン、酢酸プレドニゾロン(懸濁液)、リン酸ナトリウムプレドニゾロン(溶液)から選択される少なくとも1つであることができる。少なくとも1つの縮瞳薬は、塩化アセチルコリン、カルバコール(眼内)、カルバコール(局所)、ヨウ化エコチオフェート、ピロカルピン、塩酸ピロカルピン、硝酸ピロカルピンから選択される少なくとも1つであることができる。少なくとも1つの散瞳薬は硫酸アトロピン、塩酸シクロペントレート、塩酸エピネフリン、硼酸エピネフリル、塩酸ホマトロピン、塩酸フェニレフリン、スコポラミンヒドロブロミド、トロピカミドから選択される少なくとも1つであることができる。少なくとも1つの目の血管収縮薬は、塩酸ナファゾリン、塩酸オキシメタゾリン、塩酸テトラヒドラゾリンから選択される少なくとも1つであることができる。少なくとも1つの他方面の目薬は、塩酸アプラクロニジン(apraclonidine)、塩酸ベタキソロール、酒石酸ブリモニジニン(brimonidine)、塩酸カルテオロール(carteolol)、塩酸ジピベフリン、塩酸ドルゾラミド(dorzolamide)、エメダスチン(emedastine)ジフマレート、フルオレセインナトリウム、フマル酸ケトチフェン(ketotifen)、ラタノプロスト(latanoprost)、塩酸レボブノロール、塩酸メチプラノロール(metipranolol)、塩化ナトリウム(高張性)、マレイン酸チモロールから選択される少なくとも1つであることができる。少なくとも1つの耳の薬は、硼酸、過酸化カルバミド、クロラムフェニコール、オレイン酸トリエタノールアミンポリペプチド−縮合物から選択される少なくとも1つであることができる。少なくとも1つの鼻の薬は、ベクロメタゾンジプロピオネート、ブデゾニド(budesonide)、硫酸エフェドリン、塩酸エピネフリン、フルニゾリド、プロピオン酸フルチカゾン(fluticasone)、塩酸ナファゾリン、塩酸オキシメタゾリン、塩酸フェニレフリン、塩酸テトラヒドロゾリン、トリアムシノロンアセトニド、塩酸キシロメタゾリンから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第1041〜97頁を参照されたい。)
少なくとも1つの局所抗感染剤は、アシクロビル、アンフォテリシンB、アゼラ酸(azelaic acid)クリーム、バシトラシン、硝酸ブトコナゾール、リン酸クリンダマイシン、クロトリマゾール、硝酸エコナゾール、エリスロマイシン、硫酸ゲンタマイシン、ケトコナゾール、酢酸マフェナイド、メトロニダゾール(局所)、硝酸ミコナゾール、ムピロシン(mupirocine)、塩酸ナフチファイン、硫酸ネオマイシン、ニトロフラゾン、ニスタチン、銀スルファジアジン、塩酸テルビナファイン(terbinafine)、テルコナゾール(terconazole)、塩酸テトラサイクリン、チオコナゾール、トルナフテートから選択される少なくとも1つであることができる。少なくとも1つの殺疥癬虫薬または殺シラミ薬は、クロタミトン、リンダン、ペルメトリン(permethrin)、ピレトリンから選択される少なくとも1つであることができる。少なくとも1つの局所コルチコステロイドは、ベタメタゾンジプロピオネート、吉草酸ベタメタゾン、プロピオン酸クロベタゾール、デソニド、デスオキシメタゾン、デキサメタゾン、リン酸ナトリウムデキサメタゾン、ジフロラゾンジアセテート、フルオシノロンアセトニド、フルオシノニド、フルランドレノリド、プロピオン酸フルチカゾン(fluticasone)、ハルシオニド(halcionide)、ヒドロコルチゾン、酢酸ヒドロコルチゾン、酪酸ヒドロコルチゾン、吉草酸ヒドロコルチゾン、モメタゾンフロエート(mometasone furoate)、トリアムシノロンアセトニドから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第1098〜1136頁を参照されたい。)
少なくとも1つのビタミンまたは無機物は、ビタミンA、ビタミンB複合体、シアノコバラミン、葉酸、ヒドロキソコバラミン、ロイコボリンカルシウム、ナイアシン、ナイアシンアミド、塩酸ピリドキシン、リボフラビン、塩酸チアミン、ビタミンC、ビタミンD、コレカルシフェロール、エルゴカルシフェロール、ビタミンD類似体、ドキセルカルシフェロール(doxercalciferol)、パリカルシトール(paricalcitol)、ビタミンE、ビタミンK類似体、フィトナジオン、弗化ナトリウム、弗化ナトリウム(局所)、微量元素、クロム、銅、ヨウ素、マンガン、セレン、亜鉛から選択される少なくとも1つであることができる。少なくとも1つの熱量源は、アミノ酸浸剤(結晶)、デキストロース中のアミノ酸浸剤、電解質とのアミノ酸浸剤、デキストロース中の電解質とのアミノ酸浸剤、肝不全のためのアミノ酸浸剤、高代謝ストレスのためのアミノ酸浸剤、腎不全のためのアミノ酸浸剤、デキストロース、脂肪乳剤、中鎖トリグリセリドから選択される少なくとも1つであることができる。(例えばナーシング 2001 ドラッグハンドブックの第1137〜63頁を参照されたい。)
本発明のCH1欠失ミメティボディ抗体またはポリペプチド組成物は、さらに少なくとも1つの適切な、かつ/または有効量の組成物または製薬学的組成物を含んでなることができるが、これら組成物はそのようなモジュレーション、処置または治療が必要な細胞、組織、器官、動物または患者に対する少なくとも1つのCH1欠失ミメティボディタンパク質または抗体を含んでなり、さらに場合により少なくとも1つのTNFアンタゴニスト(例えば限定するわけではないがTNF化学物質もしくはタンパク質アンタゴニスト、TNFモノクローナル抗体もしくはポリクローナル抗体もしくはフラグメント、可溶性TNF受容体(例えばp55、p70もしくはp85)もしくはそのフラグメント、その融合ポリペプチド、または低分子TNFアンタゴニスト、例えばTNF結合タンパク質IもしくはII(TBP−1もしくはTBP−II)、ネレリモンマブ(nerelimonmab)、インフリキシマブ(infliximab)、エンテラセプト(enteracept)、CDP−571、CDP−870、アフェリモマブ(afelimomab)、レネルセプト(lenercept)等)、抗リウマチ薬(例えばメトトレキセート、オーラノフィン、オーロチオグルコース、アザチオプリン、エタネルセプト(etanercept)、金チオリンゴ酸ナトリウム、硫酸ヒドロキシクロロキン、レフルノミド(leflunomide)、スルファザルジン(sulfasalzine)、筋弛緩薬、麻薬、非ステロイド系炎症薬(NASID)、鎮痛剤、麻酔薬、鎮静剤、局所麻酔薬、神経筋遮断薬、抗菌薬(例えばアミノグリコシド、抗真菌薬、抗寄生生物薬、抗ウイルス薬、カルバペネム、セファロスポリン、フルオロキノロン、マクロライド、ペニシリン、スルホンアミド、テトラサイクリン、他の抗微生物薬)、止痒薬、コルチコステロイド、同化性ステロイド、糖尿病関連薬、無機類、栄養物質、甲状腺薬、ビタミン、カルシウム関連ホルモン、止瀉薬、鎮咳薬、制吐薬、抗潰瘍薬、緩下薬、抗凝固薬、エリスロポエチン(例えばエポエチンアルファ)、フィルグラスチム(filgrastim)(例えばG−CSF、Neupogen)、サルグラモスチン(GM−CSF、Leukine)、免疫感作、免疫グロブリン、免疫抑制薬(例えばバシリキシマブ、シクロスポリン、ダクリズマブ)、成長ホルモン、ホルモン代用薬、エストロゲン受容体モジュレーター、散瞳薬、毛様体筋麻痺薬、アルキル化薬、代謝拮抗物質、有糸分裂インヒビター、放射性薬品、抗鬱薬、抗躁薬、抗精神病薬、抗不安薬、催眠薬、交換神経作用薬、刺激物質、ドネペジル(donepezil)、タクリン(tacrine)、喘息薬物療法、ベータアゴニスト、吸入ステロイド、ロイコトリエンインヒビター、メチルキサンチン、クロモリン、エピネフリンもしくは類似体、ドルナーゼアルファ(Pulmozyme)、サイトカインもしくはサイトカインアンタゴニストの少なくとも1つから選択される有効量の少なくとも1つを含んでなる。そのようなサイトカインの非限定的例は、限定するわけではないが任意のIL−1〜IL−23を含む。適切な投薬用量は、当該技術分野では周知である。例えばWells et al.、編集、薬理療法ハンドブック(Pharmacotherapy Handbook)、第2版、アペルトン アンド ランジ(Appleton and Lange)、スタムフォード、コネチカット州(2000):PDR薬局方、タラスコンポケット薬局方(Tarascon Pocket Pharmacopoeia)2000、豪華版、タラスコン出版社、ローマ リンダ、カリフォルニア州(2000)を参照にされたい(それぞれ引用により全部、本明細書に編入する)。
製剤
上記のように本発明は安定な製剤を提供し、これは好ましくは食水または選択した塩を含む適当なバッファー、ならびに保存剤を含有する任意選択の保存溶液および製剤、ならびに製薬学的または獣医学的使用に適する多用途保存製剤であり、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントを製薬学的に許容される製剤中に含んで成る。保存製剤は少なくとも1つの既知の保存剤または任意に少なくとも1つのフェノール、m−クレゾール、p−クレゾール、o−クレゾール、クロロクレゾール、ベンジルアルコール、亜硝酸フェニル水銀、フェノキシエタノール、ホルムアルデヒド、クロロブタノール、塩化マンガン(例えばヘキサヒドレート)、アルキルパラベン(メチル、エチル、プロピル、ブチル等)、塩化ベンザルコニウム、塩化ベンズエトニウム、デヒドロ酢酸ナトリウムおよびチメロサール、またはそれらの混合物から成る群から選択される保存剤を水性希釈剤中に含む。適当な濃度または混合物は、0.001〜5%のような、または限定するわけではないが0.001、0.003、0.005、0.009、0.01、0.02、0.03、0.05、0.09、0.1、0.2、0.3、0.4、0.5、0.6、0.7、0.8、0.9、1.0、1.1、1.2、1.3、1.4、1.5、1.6、1.7、1.8、1.9、2.0、2.1、2.2、2.3、2.4、2.5、2.6、2.7、2.8、2.9、3.0、3.1、3.2、3.3、3.4、3.5、3.6、3.7、3.8、3.9、4.0、4.3、4.5、4.6、4.7、4.8、4.9またはこの中の任意の範囲または値のような、当該技術分野で知られているように使用することができる。非限定的な例には、保存剤なし、0.1〜2% m−クレゾール(例えば0.2、0.3、0.4、0.5、0.9、1.0%)、0.1〜3%ベンジルアルコール(例えば0.5、0.9、1.1、1.5、1.9、2.0、2.5%)、0.001〜0.5%チメロサール(例えば0.005、0.01)、0.001〜2.0%フェノール(例えば0.05、0.25、0.28、0.5、0.9、1.0%)、0.0005〜1.0%アルキルパラベン(1つまたは複数)(例えば0.00075、0.0009、0.001、0.002、0.005、0.0075、0.009、0.01、0.02、0.05、0.075、0.09、0.1、0.2、0.3、0.5、0.75、0.9、1.0%)等を含む。
治療的応用
ミメティボディに関する本発明は、細胞、組織、器官、動物または患者の、限定するわけではないが、少なくとも1つの貧血、癌の処置に関連する貧血、放射線療法もしくは化学療法に関連する貧血、ウイルスもしくは細菌の処置に関する貧血、腎性貧血、早熟の貧血(anemia of prematurity)、小児および/または成人の癌に付随する貧血、リンパ腫、骨髄腫、多発性骨髄腫に関連する貧血、AIDSに付随する貧血を含む貧血をモジュレートまたは処置する方法、選択的手術を待つ、術前もしくは術後の自己血液供与、自己血液供与もしくは輸血、周術期管理を受けた、または受けていない患者、周期性好中球減少症もしくはコストマン症候群(先天性顆粒球減少症)、末期腎疾患、透析に関連する貧血、慢性腎不全、先天性低形成貧血のような原発性造血疾患、サラセミアメジャー、または鎌状赤血球症、鎌状赤血球症の血管閉塞性合併症の同時処置を提供する。Furman et al.,Pediatrics 1992;90:716−728,Goldberg Science.1988;242:1412−1415;Paul et al.,Exp Hematol.1984;12:825−830;Elrslev et al.,Arch Intern Med.1968;122:230−235;Ersley et al.,Ann Clin Lab Sci.1980;10:250−257;Jacobs et al.,Nature,1985;313:806−810;Lin et al.,Proc.Natl.Acad.Sci.USA 1985;82:7580−7584;Law et al.,Proc.Natl.Acad.Sci.USA.1986;83:6920−6924;Goldwasser et al.,J.Biol.Chem.1974;249;4202−4206;Eaves et al.,Blood.1978;52:1196−1210;Sawyer et al.,Blood.1989;74:103−109;Winearls et al.,Lancet.1986;2:1175−1178;Eschbach et al.,N Engl J Med.1987;316:73−78;Eschbach et al.,Ann Intern Med.1989;111:992−1000(それぞれ引用により全部、本明細書に編入する)。
TNF受容体分子
本発明に有用な好適なTNF受容体分子は、TNFαに高親和性で結合するものであり(例えばFeldmann et al.、国際公開第92/07076号パンフレット(1992年4月30日公開);Schall et al.,Cell 61:361−370(1990);およびLoetscher et al.,Cell 61:351−359(1990)を参照にされたい、これらは引用により全部、本明細書に編入する)、そして場合により低い免疫原性を有するものである。特に55KDa(p55 TNF−R)および75kDa(p75 TNF−R)TNF細胞表面受容体が本発明に有用である。受容体またはそれらの機能的部分の細胞外ドメイン(ECD)を含んで成るこれらの受容体の短縮された形態も(例えばCorcoran et al.,Eur.J.Biochem.223:831−840(1994)を参照にされたい)、本発明に有用である。ECDを含んで成るTNF受容体の短縮化形は、尿および血清中に30kDaおよび40kDaのTNFα阻害結合タンパク質として検出された(Engelmann,H.,et al.,J.Biol.Chem.265:1531−1536(1990))。TNF受容体多量体分子およびTNF免疫受容体融合分子、およびそれらの誘導体およびフラグメントまたは部分は、本発明の方法および組成物に有用なTNF受容体分子のさらなる例である。本発明で使用できるTNF受容体分子は、症状の良好から優れた緩和および低い毒性で長期間、患者を処置するためのそれらの能力が特徴である。低い免疫原性および/または高い親和性、ならびに他の不確定な特性は、達成される治療的結果に寄与し得る。
治療的投与
本発明に従い多くの既知の、および開発された様式を、本発明の少なくとも1つのCH1ミメティボディまたは特定部分またはバリアントを投与するために使用することができる。肺投与を以下の記載で使用するが、他の投与様式を本発明に従い使用して適切な結果を得ることができる。
非経口製剤および投与
非経口投与用の製剤は、通常の賦形剤として滅菌水または塩水、ポリエチレングリコールのようなポリアルキレングリコール、植物起源の油、水素化ナフタレン等を含むことができる。注入用の水性または油性懸濁液は、既知の方法に従い適当な乳化剤または加湿剤および沈殿防止剤を使用して調製することができる。注入用の薬剤は、水溶液または溶媒中の滅菌された注入可能溶液または懸濁液のような非毒性で、非経口投与性の希釈剤であることができる。使用可能な賦形剤または溶剤として、水、リンゲル溶液、等張性塩水等を利用できる;通例の溶媒、または沈殿防止溶媒として、滅菌された非揮発性油を使用することができる。これらの目的のために、任意の種類の非揮発性油および脂肪酸を使用でき、それらには天然または合成または半合成の脂肪油または脂肪酸;天然または合成または半合成のモノ−もしくはジ−またはトリ−グリセリドを含む。非経口投与は当該技術分野で知られており、そして限定するわけではないが通例の注入手段、米国特許第5,851,198号明細書に記載されたガスで圧縮した、針を含まない注入デバイス、および米国特許第5,839,446号明細書に記載されたレーザーパーホレーターデバイスを含む(これらの明細書は引用により全部、本明細書に編入する)。
代替送達
本発明はさらに少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントの、非経口的、皮下、筋肉内、静脈内、ボーラス、膣、直腸、頬内、舌下、鼻内または経皮による投与に関する。タンパク質,CH1欠失ミメティボディまたは特定部分またはバリアント組成物は、非経口(皮下、筋肉内もしくは静脈内)投与、特に液体溶液もしくは懸濁液の状態で使用するために;膣または直腸投与、特にクリームおよび坐薬のような半固体形で使用するために;頬内、または舌下投与、特に錠剤またはカプセル形態で;あるいは鼻内、特に粉末、点鼻またはエーロゾルまたは特定薬剤(certain agent)の形態で;あるいは皮膚構造をモディファイし、または経皮パッチ中の薬剤濃度を上げるためのジメチルスルフォキシドのような化学的エンハンサー(Junginger et al.、「薬剤の浸透強化(Drug Permeation Enhancement)」;Hsieh,D.S.、編集、第59−90頁(マルセルデッカー(Marcel Dekker)社、ニューヨーク 1994、引用により全部、本明細書に編入する)を用いて、またはタンパク質およびペプチドを含む製剤の皮膚上への適用を可能にする酸化剤(国際公開第98/53847号パンフレット)を用いて、または電気穿孔のような一過性の輸送路を作るために電場を適用して、またはイオン導入法のような皮膚を通る荷電した薬剤の移動性を上げるために、またはソノホレシス(sonophoresis)のような超音波を適用して(米国特許第4,309,989号および同第4,767,402号明細書)、経皮的に、特にゲル、軟膏、ローション、懸濁液またはパッチ送達系で使用するために調製することができる(上記の刊行物および特許は引用により全部、本明細書に編入する)。
肺/鼻投与
肺投与には、好ましくは少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアント組成物は、肺または洞のより低い気道に到達するために効果的な粒子サイズで送達される。本発明に従い、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントは吸入による治療薬の投与について当該技術分野で既知の種々の吸入または鼻デバイスにより送達することができる。エーロゾル化した製剤を患者の洞腔または肺胞に沈積させることができるこれらのデバイスには、計量用量吸入器(metered dose inhaler)、ネブライザー、乾燥粉末ジェネレーター、噴霧器等を含む。CH1欠失ミメティボディまたは特定部分またはバリアントを肺または鼻投与に向けるための適当な他のデバイスも当該技術分野では既知である。すべてのそのようなデバイスが、エーロゾル中のCH1欠失ミメティボディまたは特定部分またはバリアントを分配するための投与に適する製剤に使用することができる。そのようなエーロゾルは、溶液(水性または非水性の両方)または固体粒子のいずれかから成ることができる。Ventolin(商標)計量用量吸入器のような計量用量呼入器は、多くは推進ガスを使用し、そして吸息中の作動が必要である(例えば国際公開第94/16970号、同第98/35888号パンフレットを参照にされたい)。Turbuhaler(商標)(アストラ:Astra)、Rotahaler(商標)(グラクソ:Glaxo)、Diskus(商標)(グラクソ)、Spiros(商標)呼入器(ジュラ:Dura)、インハーレセラピューティクス(Inhale Therapeutics)により販売されているデバイスおよびSpinhaler(商標)粉末呼入器(フィソンス:Fisons)のような粉末吸入器は、混合粉末の呼吸作動を使用する(米国特許第4668218号明細書 アストラ、欧州特許第237507号明細書 アストラ、国際公開第97/25086号パンフレット グラクソ、国際公開第94/08552号パンフレット ジュラ、米国特許第5458135号明細書 インハーレ、国際公開第94/06498号パンフレット フィソンス、すべて引用により本明細書に編入する)。AERx(商標)アラディギム(Aradigm)、Ultravent(商標)ネブライザー(マリンクロッド:Mallinckrodt)、およびAcornII(商標)ネブライザー(マークエスト メディカル プロダクツ:Marquest Medical Products)(米国特許第5404871号明細書 アラディギム、国際公開第97/22376号パンフレット)のようなネブライザー(上記技術文献は引用により全部、本明細書に編入する)は、溶液からエーロゾルを生成するが、計量用量吸入器、乾燥粉末吸入器等は、小さい粒子のエーロゾルを生成する。市販されている吸入器デバイスのこれらの具体的例は、本発明の実施に適する具体的なデバイスの代表であり、本発明の範囲を限定するものではない。好ましくは少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントを含んで成る組成物は、乾燥粉末吸入器または噴霧器により送達される。これらは本発明の少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントを投与するための吸入デバイスの幾つかの望ましい特徴である。例えば吸入デバイスによる送達は有利には、信頼性があり、再現性があり、そして正確である。吸入デバイスは場合により、良好な呼吸適性のために小さい乾燥粒子(例えば約10μm未満、好ましくは約1〜5μm)を送達することができる。
噴霧としてのCH1欠失ミメティボディまたは特定部分またはバリアント組成物の投与
CH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質を含む噴霧は、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントの懸濁液または溶液を加圧下のノズルを通すことにより生成することができる。ノズルのサイズおよび形状、かける圧力および液体供給速度は、所望の出力および粒子サイズを達成するために選択することができる。電気噴霧は例えば毛細管またはノズル供給部に連結した電場により生成できる。有利には噴霧器により送達される少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質の粒子は、約10μm未満、好ましくは約1〜約5μmの範囲、そして最も好ましくは約2μm〜3μmの粒子サイズを有する。
ネブライザーによるCH1欠失ミメティボディまたは特定部分またはバリアント組成物の投与
CH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質は、ジェットネブライザーまたは超音波ネブライザーのようなネブライザーにより投与することができる。典型的にはジェットネブライザーでは、圧縮空気源を使用して開口部を通る高速エアジェットを作成する。ガスがノズルを越えて膨張すると低圧領域が作成され、これが液体リザーバーに連結された毛細管を通ってCH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質の溶液を引き出す。毛細管からの液流は、管から出る時に不安定なフィラメントおよび液滴に剪断され、エーロゾルを作成する。ある範囲の形状、流速、およびそらせ型を使用して、上記のジェットネブライザーから所望の性能特性を達成することができる。超音波ネブライザーでは、高周波電気エネルギーを使用して、典型的には圧電変圧器を使用して、振動的、機械的エネルギーを作成することができる。このエネルギーを直接的に、またはカップリング流体を通すいずれかでCH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質の製剤に伝え、CH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質を含むエーロゾルを作成する。有利にはネブライザーにより送達されるCH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質の粒子は、約10μm未満、好ましくは約1μm〜約5μmの範囲、そして最も好ましくは約2μm〜3μmの粒子サイズを有する。
計量用量吸入によるCH1欠失ミメティボディまたは特定部分またはバリアント組成物の投与
計量用量吸入器(metered dose inhaler:MDI)では、推進剤、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアント、および任意の賦形剤または他の添加剤を、液化圧縮ガスを含む混合物としてキャニスターに含む。計量バルブの作動は好ましくは、約10μm以下、好ましくは約1μm〜約5μm、そして最も好ましくは約2μm〜3μmの範囲のサイズの粒子を含むエーロゾルとしての混合物を放出する。所望のエーロゾル粒子サイズは、ジェット−ミル(jet−milling)、噴霧乾燥、臨界点縮合等を含む当業者に既知の様々な方法により生成されるCH1欠失ミメティボディまたは特定部分またはバリアント組成物タンパク質の製剤を使用することにより得られる。好適な計量用量吸入器には、3Mまたはグラクソにより製造され、そしてヒドロフルオロカーボン推進剤を採用するものを含む。
粘膜製剤および投与
粘膜表面を通して吸収させるために、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントを投与する組成物および方法には、複数のミクロン以下の粒子、粘膜接着性高分子、生物活性ペプチドおよび水性の連続相を含んで成る乳液を含み、これは乳液粒子の粘膜接着を達成することにより粘膜表面を通る吸収を促進する(米国特許第5,514,670号明細書)。本発明の乳液の適用に適する粘膜表面には、角膜、結膜、頬、舌、鼻、膣、肺、胃、腸および直腸経路の投与を含む。膣または直腸投与用の製剤、例えば坐薬は、賦形剤として例えばポリアルキレングリコール、ワセリン、カカオ脂等を含むことができる。鼻内投与用の製剤は固体であることができ、そして賦形剤として例えばラクトースを含み、または点鼻の水性もしくは油性溶液であることができる。頬内投与には賦形剤は糖、ステアリン酸カルシウム、ステアリン酸マグネシウム、糊化(pregelinated)澱粉等を含む(米国特許第5,849,695号明細書)。
経口製剤および投与
経口用の製剤は、腸壁の透過性を人工的に上げるための補助剤(例えばレゾルシノールおよびポリオキシエチレンオレイルエーテルおよびn−ヘキサデシルポリエチレンエーテルのような非イオン性表面活性剤)の同時投与、ならびに酵素的分解を阻害するための酵素阻害剤(例えば膵臓トリプシンインヒビター、ジイソプロピルフルオロホスフェート(DFF)およびトラシロール)の同時投与に依存する。経口投与用の固体型剤形の活性成分化合物を、シュクロース、ラクトース、セルロース、マンニトール、トレハロース、ラフィノース、マルチトール、デキストラン、澱粉、寒天、アルギネート、キチン、キトサン、ペクチン、トラガカントガム、アラビアガム、ゼラチン、コラーゲン、カゼイン、アルブミン、合成もしくは半合成ポリマーおよびグリセリドを含む少なくとも1つの添加剤と混合することができる。これらの剤形は他の種類(1つまたは複数)の添加剤、例えば不活性な希釈剤、ステアリン酸マグネシウム、パラベンのような潤滑剤、ソルビン酸、アスコルビン酸、アルファ−トコフェロールのような保存剤、システインのような酸化防止剤、崩壊剤、結合剤、増粘剤、緩衝剤、甘味料、風味剤(flavoring agent)、香料等も含むことができる。
経皮製剤および投与
経皮投与には、少なくとも1つのCH1欠失ミメティボディまたは特定部分またはバリアントをリポソームまたはポリマー性ナノ粒子、マイクロ粒子、マイクロカプセルまたは微小球(特に言及しない限り、集合的にマイクロ粒子と呼ぶ)のような送達デバイスにカプセル化する。多数の適当なデバイスが知られており、それらにはポリ乳酸、ポリグリコール酸およびそれらのコポリマーのようなポリヒドロキシ酸、ポリオルトエステル、ポリ無水物およびポリホスファゼンのような合成ポリマー、ならびにコラーゲン、ポリアミノ酸、アルブミンおよび他のタンパク質、アルギネートおよび他の多糖およびそれらの組み合わせのような天然ポリマーから作られたマイクロ粒子を含む(米国特許第5,814,599号明細書)。
持効性投与および製剤
本発明の化合物は個体に長期間、例えば単回投与から1週間から1年の期間送達することがしばしば望ましい。種々の緩効性、貯蔵またはインプラント剤形を利用することができる。例えば剤形は、体液中での溶解度が低い化合物の製薬学的に許容される非毒性塩、例えば(a)リン酸、硫酸、クエン酸、酒石酸、タンニン酸、パモ酸、アルギン酸、ポリグルタミン酸、ナフタレン モノ−もしくはジ−スルホン酸、ポリガラクツロン酸等のような多塩基性酸との酸付加塩;(b)亜鉛、カルシウム、ビスマス、バリウム、マグネシウム、アルミニウム、銅、コバルト、ニッケル、カドミウム等のような多価金属カチオン、または例えばN,N’−ジベンジル−エチレンジアミンまたはエチレンジアミンから形成される有機カチオンとの塩;あるいは(c)(a)および(b)の組み合わせ、例えばタンニン酸亜鉛塩を含むことができる。さらに本発明の化合物は、または好ましくは今ちょうど記載したような比較的不溶性の塩をゲル、例えば注入に適するゴマ油を含む例えばモノステアリン酸アルミニウムゲルに配合することができる。特に好適な塩は、亜鉛塩、タンニン酸亜鉛塩、パモ酸塩等である。注入用の別の種類の緩効性貯蔵製剤は、例えば米国特許第3,773,919号明細書に記載されているようなポリ乳酸/ポリグリコール酸ポリマーのような緩効分解型の非毒性、非抗原性ポリマー中にカプセル化するために分散した化合物または塩を含む。化合物または好ましくは上記の比較的不溶性の塩は、特に動物で使用するために、コレステロールマトリックスシラスティック(silastic)ペレット中に配合することもできる。さらなる緩効性の、貯蔵またはインプラント製剤、例えばガスまたは液体リポソームが技術文献で知られている(米国特許第5,770,222号明細書および「徐放性および放出制御薬剤送達系(Sustained and Controlled Release Drug Delivery Systems)」、J.R.Robinson 編集、マルセルデッカー社、ニューヨーク、1978)。
典型的な哺乳動物発現ベクターは、mRNAの転写の開始を媒介する少なくとも1つのプロモーター要素、CH1欠失ミメティボディまたは特定部分またはバリアントのコード配列および転写の終結および転写産物のポリアデニル化に必要なシグナルを含む。さらなる要素にはエンハンサー、Kozak配列およびRNAスプライシングのための供与および受容部位により挟まれた介在配列を含む。高度に効率的な転写はSV40に由来する初期および後期プロモーター、レトロウイルス、例えばRSV、HTLVI、HIVIに由来する長い末端反復配列(LTRS)、およびサイトメガロウイルス(CMV)の初期プロモーターにより達成され得る。しかし細胞要素(例えばヒトアクチンプロモーター)も使用することができる。本発明の実施に使用するために適当な発現ベクターには、例えばpIRES1neo、pRetro−Off、pRetro−On、PLXSNまたはpLNCX(クロンテック ラボズ(Clonetech Labos)、パロアルト、カリフォルニア州)、pcDNA3.1(+/−)、pcDNA/Zeo(+/−)またはpcDNA3.1/Hygro(+/−)(インビトロジェン(Invitrogen))、PSVLおよびPMSG(ファルマシア(Pharmacia)、ウプサラ、スウェーデン)、pRSVcat(ATCC37152)、pSV2dhfr(ATCC37146)およびpBC12MI(ATCC67109)のようなベクターを含む。使用できた哺乳動物宿主細胞には、ヒトHela 293、H9およびJurkat細胞、マウスNIH3T3およびC127細胞、Cos1、Cos7およびCV1、quailQC1−3細胞、マウスL細胞およびチャイニーズハムスター卵巣(CHO)細胞を含む。
CHO細胞中でのクローニングおよび発現
ベクターpC4をCH1欠失ミメティボディまたは特定部分またはバリアントの発現に使用する。プラスミドpC4は、プラスミドpSV2−dhfr(ATCC寄託番号37146)の誘導体である。プラスミドはマウスDHFR遺伝子をSV40初期プロモーターの制御下に含む。これらのプラスミドでトランスフェクトしたジヒドロ葉酸活性を欠くチャイニーズハムスター卵巣または他の細胞は、細胞を化学療法剤であるメトトレキセートを補充した選択培地(例えばアルファマイナスMEM、ライフテクノロジーズ(Life Technologies)、ゲチスバーグ、メリーランド州)中で成長させることにより選択することができる。メトトレキセート(MTX)に対して耐性の細胞中のDHFR遺伝子の増幅が十分に示された(例えば、F.W.Alt,et al.,J.Biol.Chem.253:1357−1370(1978);J.L.Hamlin and C.Ma.Biochem.et Biophys.Acta 1097:107−143(1990);およびM.J.Page and M.A.Sydenham,Biotechnology 9:64−68(1991)を参照にされたい)。MTXの濃度を上昇させて成長させた細胞は、DHFR遺伝子の増幅の結果として目的酵素であるDHFRの過剰生産により薬剤への耐性を生じる。第2遺伝子がDHFR遺伝子に連結されている場合、これは通常、同時に増幅され(co−amplified)、そして過剰に発現される。当該技術分野では、この取り組みを使用して1,000コピー以上の増幅した遺伝子(1つまたは複数)を持つ細胞株を発生できることが知られている。続いてメトトレキセートを離脱する時、宿主細胞の1以上の染色体(1つまたは複数)に組み込まれた増幅された遺伝子を含む細胞株が得られる。
背景:EMP−1(EPO模倣ペプチド−1)は、ヒトのエリスロポエチン(HuEPO)とは配列相同性が無いが、(二量体として)EPO受容体を活性化する能力を持つ20個のアミノ酸のペプチドである(Wrighton et al.,1996,Science,vol.273,458−463)。しかしその比較的低い活性(HuEPOよりも10,000〜100,000倍低い)、および短い半減期(50%血清中、8時間のエクスビボ半減期、インビボの半減期は未知)により、その治療薬としての用途には欠陥がある。ゆえにその効力を乱すことなく、しかも可能であるならば向上させる、より長い半減期をペプチドに与えることが必要であった。このために、ペプチドの二量体化を安定化させることにより、または半減期を増すためにペプチドに、より大きな構造を包含させることにより、EMP−1の活性を上げる試みが数回にわたりなされてきた。Wrighten et al.(1997,Nature Biotechnology,vol.15,1261−65)は、ビオチン標識化EMP−1とストレプトアビジンと合わせて、二量体化を安定化させた。彼らはインビトロの細胞増殖アッセイで100倍の活性増加を見た。また彼らは、抗−ビオチン抗体を使用してペプチド二量体を安定化したが、活性にわずか10倍の上昇が見られただけであった。同じ著者がEMP−1の化学的に定められた二量体形を調製した。この場合、活性に100倍の上昇がインビボで見られた。別のグループはポリエチレングリコール(PEG)への共有結合を介してEMP−1の活性を向上させようとした(Johnson et al.,1997,Chem.& Bio.,vol.4(12),939−50)。彼らは1000倍までの効力の増加を報告したが、その構築物はマウスで免疫原性であることが分かった(ペプチドに対する抗体が作られた)(Dana Johnson,私信)。Kuai et al.(2000,J.Peptide Res.,vol.56,59−62)はEMP−1ペプチドをプラスミノーゲンアクチベーターインヒビター1(PAI−1)の配列に挿入した。この骨組み(scaffold)へのEMP−1の挿入は、二量体化を安定化させ、そして半減期も上昇させると考えられた。インビボのアッセイでは、この構築物の効力がEMP−1単独よりも2500倍高いようであった。これらの実験では異なるインビトロアッセイおよびインビボモデルを使用し、そして報告された効力は互いに比較できず、または結果を本明細書に提示できないことに注意すべきである。
本発明のEMP−1 CH1欠失ミメティボディ
本発明の具体的な、非限定的例は、EMP−NfusCG1構築物であり、ここでVは自然に存在する抗体の最初の3アミノ酸であり、Pepは生物活性EMP−1ペプチドの単一コピーであり、そしてFlexはGly−Gly−Gly−Ser柔軟性リンカーの直列反復である。V2は自然に存在するIgGのJ領域であり、pHingeは完全なIgG1ヒンジ領域であり、そしてCH2&CH3はIgG1アイソタイプのサブクラスである。この構造はEMP−1ペプチドを束縛するが、集成されるホモ二量体の一部としてペプチドの二量体化が安定化されるように十分な柔軟性を可能とする。これを支持するように、インビトロの細胞増殖アッセイでのEMP−NfusCG1の活性は、EMP−1ペプチドよりも約550倍高く、そして組換えHuEPO(rHuEPO)よりも4〜6倍低いだけである。さらにこの構築物の半減期は、rHuEPOまたはEMP−1ペプチド単独の多数倍となり、そしてIgGに類似すると期待される。等しい活性単位を与えた時、EMP−NfusCG1で処置した正常なマウスは、rHuEPOで処置したマウスに比べて有意に高い最大ヘマトクリットを一貫して達成し、そして上昇したレベルは長期間維持される。この構築物は細胞から効率的に分泌され、そして正しくフォールディングされるようであり;第1世代のミメティボディに付随する問題を克服する。
Claims (36)
- 配列番号1112のアミノ酸配列をコードする少なくとも1つのポリヌクレオチドまたはそれに相補的なポリヌクレオチドを含んでなる、少なくとも1つのCH1欠失ミメティボディ核酸。
- 配列番号1113のアミノ酸配列をコードする少なくとも1つのポリヌクレオチドまたはそれに相補的なポリヌクレオチドを含んでなる、少なくとも1つのCH1欠失ミメティボディ核酸。
- 式(I):
のポリペプチドをコードする少なくとも1つのポリヌクレオチドを含んでなる少なくとも1つのCH1欠失ミメティボディ核酸。 - 配列番号1112の連続するアミノ酸のすべてを含んでなる、少なくとも1つのCH1欠失ミメティボディポリペプチド。
- 配列番号1113の連続するアミノ酸のすべてを含んでなる、少なくとも1つのCH1欠失ミメティボディポリペプチド。
- 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 式(I):
のポリペプチドを含んでなる少なくとも1つのCH1欠失ミメティボディポリペプチド。 - 上記ポリペプチドが少なくとも1つのPepポリペプチドの少なくとも1つの活性を有する、請求項1ないし15のいずれかに記載の(n)CH1欠失ミメティボディ核酸またはCH1欠失ミメティボディポリペプチド。
- 請求項1ないし15のいずれかに記載の少なくとも1つのCH1欠失ミメティボディポリペプチドに特異的に結合するモノクローナルもしくはポリクローナル抗体、融合タンパク質またはそのフラグメントを含んでなるCH1欠失ミメティボディ抗体。
- 請求項1ないし17のいずれかに記載の少なくとも1つのCH1欠失ミメティボディポリペプチドまたはCH1欠失ミメティボディ抗体をコードするCH1欠失ミメティボディ核酸。
- 請求項1ないし3のいずれかに記載の単離された核酸、または請求項4ないし15のいずれかに記載のCH1欠失ミメティボディをコードする核酸、またはそのようなコードする核酸に相補的な核酸の少なくとも1つを含んでなるCH1欠失ミメティボディベクター。
- 請求項18に記載の単離された核酸を含んでなるCH1欠失ミメティボディ宿主細胞。
- 上記宿主細胞が、COS−1、COS−7、HEK293、BHK21、CHO、BSC−1、HepG2、653、SP2/0、293、NSO、DG44CHO、CHOK1、HeLa、骨髄腫細胞もしくはリンパ腫細胞、またはそれらの任意の誘導体、不死化または形質転換した細胞から選択される少なくとも1つである、請求項20に記載のCH1欠失ミメティボディ宿主細胞。
- CH1欠失ミメティボディまたは抗体が検出可能もしくは回収可能な量で発現されるように、in vitro、in vivoもしくはin situの条件下で、請求項18に記載の核酸を翻訳することを含んでなる、少なくとも1つのCH1欠失ミメティボディポリペプチドまたはCH1欠失ミメティボディ抗体の生産法。
- 請求項1ないし17のいずれかに記載のCH1欠失ミメティボディ核酸、CH1欠失ミメティボディポリペプチドまたはCH1欠失ミメティボディ抗体の少なくとも1つを含んでなる組成物。
- 上記組成物が、少なくとも1つの製薬学的に許容され得る担体または希釈剤をさらに含んでなる請求項23に記載の組成物。
- 少なくとも1つの検出可能な標識もしくはレポーター、TNFアンタゴニスト、抗感染薬、心血管(CV)系薬、中枢神経系(CNS)薬、自律神経系(ANS)薬、気道薬、胃腸管(GI)薬、ホルモン薬、流体もしくは電解質バランスのための薬剤、血液製剤、抗腫瘍薬、免疫調節薬、目、耳もしくは鼻の薬、局所薬、栄養剤、サイトカインまたはサイトカインアンタゴニストから選択される、治療的に有効量の少なくとも1つの化合物、組成物またはポリペプチドを含んで成る少なくとも1つの組成物をさらに含んでなる、請求項23に記載の組成物。
- 液体、ガスまたは乾燥物、溶液、混合物、懸濁液、乳液もしくはコロイド、凍結乾燥調製物もしくは粉末から選択される少なくとも1つの形態である、請求項22に記載の組成物。
- 細胞、組織、器官または動物のCH1欠失ミメティボディリガンド関連状態を診断または処置する方法であって、
(a)有効量の請求項1ないし17のいずれかに記載の少なくとも1つのCH1欠失ミメティボディ核酸、ポリペプチドまたは抗体を含んでなる組成物を、該細胞、組織、器官または動物に接触または投与することを含んでなる上記方法。 - 上記の有効量が、上記細胞、組織、器官または動物1キログラムあたり0.001〜50mgのCH1欠失ミメティボディ抗体;0.000001〜500mgの該CH1欠失ミメティボディ;または0.0001〜100μgの該CH1欠失ミメティボディ核酸である、請求項27に記載の方法。
- 上記接触または上記投与が、非経口、皮下、筋肉内、静脈内、網内、気管支内、腹内、嚢内、軟骨内、洞内、腔内、小脳内、脳室内、結腸内、頸管内、胃内、肝臓内、心筋内、骨内、骨盤内、心膜内、腹腔内、胸膜腔内、前立腺内、肺内、直腸内、腎臓内、網膜内、脊椎内、滑液包内、胸内、子宮内、膀胱内、病変内局所、ボーラス、膣、直腸、頬内、舌下、鼻内または経皮から選択される少なくとも1つの様式による、請求項27に記載の方法。
- 上記(a)の接触または投与の前、同時または後に少なくとも1つの検出可能な標識もしくはレポーター、TNFアンタゴニスト、抗感染薬、心血管(CV)系薬、中枢神経系(CNS)薬、自律神経系(ANS)薬、気道薬、胃腸管(GI)薬、ホルモン薬、流体もしくは電解質バランスのための薬剤、血液製剤、抗腫瘍薬、免疫調節薬、目、耳もしくは鼻の薬、局所薬、栄養剤、サイトカインまたはサイトカインアンタゴニストから選択される、有効量の少なくとも1つの化合物またはポリペプチドを含んで成る少なくとも1つの組成物を投与することをさらに含んでなる、請求項27に記載の方法。
- 請求項1ないし17のいずれかに記載の少なくとも1つの単離されたCH1欠失ミメティボディポリペプチド、抗体または核酸を含んでなるデバイスであって、該デバイスが該少なくとも1つの該CH1欠失ミメティボディポリペプチド、抗体または核酸を、非経口、皮下、筋肉内、静脈内、網内、気管支内、腹内、嚢内、軟骨内、洞内、腔内、小脳内、脳室内、結腸内、頸管内、胃内、肝臓内、心筋内、骨内、骨盤内、心膜内、腹腔内、胸膜腔内、前立腺内、肺内、直腸内、腎臓内、網膜内、脊椎内、滑液包内、胸内、子宮内、膀胱内、病変内局所、ボーラス、膣、直腸、頬内、舌下、鼻内または経皮から選択される少なくとも1つの様式により接触または投与するために適する上記デバイス。
- 包装材料および請求項1ないし17のいずれかに記載の少なくとも1つの単離されたCH1欠失ミメティボディポリペプチド、抗体または核酸を含んでなる容器を含んでなる、ヒトの製薬学的または診断的使用のための製品。
- 上記容器が非経口、皮下、筋肉内、静脈内、網内、気管支内、腹内、嚢内、軟骨内、洞内、腔内、小脳内、脳室内、結腸内、頸管内、胃内、肝臓内、心筋内、骨内、骨盤内、心膜内、腹腔内、胸膜腔内、前立腺内、肺内、直腸内、腎臓内、網膜内、脊椎内、滑液包内、胸内、子宮内、膀胱内、病変内局所、ボーラス、膣、直腸、頬内、舌下、鼻内または経皮送達デバイスまたはシステムの構成要素である、請求項17に記載の製品。
- 検出可能または回収可能な量で上記ポリペプチド、抗体または核酸を発現することができる少なくとも1つの宿主細胞、トランスジェニック動物、トランスジェニック植物、植物細胞を準備することを含んでなる、請求項1ないし17のいずれかに記載の少なくとも1つの単離されたCH1欠失ミメティボディポリペプチド、抗体または核酸の生産法。
- 請求項34に記載の方法により生産された少なくとも1つのCH1欠失ミメティボディポリペプチド、抗体または核酸。
- 本明細書に記載する発明。
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JP2006504406A (ja) * | 2002-06-28 | 2006-02-09 | セントカー・インコーポレーテツド | 哺乳動物のch1欠失ミメティボディ、組成物、方法および使用 |
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JP2007507225A (ja) * | 2003-09-30 | 2007-03-29 | セントカー・インコーポレーテツド | ヒトepo模倣ヒンジコアミメティボディ、組成物、方法および使用 |
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KR20050033563A (ko) | 2005-04-12 |
EP1575499A2 (en) | 2005-09-21 |
WO2004002424A8 (en) | 2005-06-30 |
IL165992A0 (en) | 2006-01-15 |
CA2490411A1 (en) | 2004-01-08 |
US7241733B2 (en) | 2007-07-10 |
WO2004002424A2 (en) | 2004-01-08 |
MXPA05000202A (es) | 2005-09-30 |
BR0312276A (pt) | 2005-04-26 |
US20050191301A1 (en) | 2005-09-01 |
AU2003256336A1 (en) | 2004-01-19 |
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