JP2022501337A - 皮膚疾患を治療するための方法および組成物 - Google Patents
皮膚疾患を治療するための方法および組成物 Download PDFInfo
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Abstract
Description
合衆国および世界中で数百万の人々が皮膚疾患を罹患している。合衆国では、2013年にアメリカ人およそ8500万人が少なくとも1つの皮膚疾患について医師の診察を受けた。24種の皮膚カテゴリーの半分は、致死的転帰を有し、皮膚疾患の直接の医療費は460億ドルと概算された。炎症は、微生物性、自己免疫性、アレルギー、恒常的、代謝、物理的および新生物傷害によって生じる皮膚疾患の基本的メカニズムである(表1を参照されたい)。
皮膚ケラチノサイト、上皮細胞およびメラノサイトを含む非免疫細胞は、毛包も含有する皮膚の最外側層を形成する。これらの細胞は、炎症性傷害に晒される。別の非免疫細胞型、内皮細胞は、小さな、中程度のおよび大きな血管の最内側の内膜を含む。これらの非免疫細胞は、重要な「バリア」機能を提供するだけでなく、炎症の外来性および内在性の原因を認識することに関与する第1線のセンチネルでもある。戦略的に配置されているマクロファージ、樹状細胞、ナチュラルキラー(NK)細胞ならびに群1、2および3自然リンパ球系細胞(ILC)と共に、非免疫細胞は、炎症発症性刺激の存在を免疫細胞に警告し、炎症性応答を調節する。免疫細胞は、顆粒球としても公知であり、好中球、好塩基球および好酸球に分かれる多形核白血球を含む。骨髄性前駆体からも生じる単核食細胞は、単球、マクロファージおよび樹状細胞を含む。リンパ球系細胞は、BおよびTリンパ球、ナチュラルキラーT細胞ならびにILCを含む。微生物因子(microbial agent)、アレルゲン、自己抗原、過剰な代謝物およびホルボール−12−ミリストレート−13−アセテート(PMA、ホルボールエステルとも呼ばれる)に代表される化学物質などの炎症性傷害は、ストレス応答性転写因子(SRTF)ならびに、ステロール調節エレメント結合タンパク質(SREBP)1および2ならびに炭水化物調節エレメント結合タンパク質(CHREBP)などの代謝転写因子(MTF)をリクルートするシグナル伝達経路の活性化を誘発する。これらの炎症誘発性および代謝トランス活性化因子は、インポーチンアルファおよびベータ(図1AおよびB)と呼ばれる輸送シャトルによって核に運ばれる。炎症誘発性シグナル伝達カスケードは、細胞の核に達し、ゲノムの広範な再プログラミングを誘導する。MTFは、食物性脂肪および糖の過食によって活性化される。結果として、炎症の複数のメディエーターが産生される。それらは、それら自体の炎症のメディエーターを産生する免疫細胞を攻撃し、それにより皮膚および周囲の組織において炎症性応答を強化および永続化する。皮膚損傷が結果として生じる。これは、炎症の種類によって変化する(表1)。
炎症性皮膚障害を治療することに関連する方法および組成物が開示される。
本明細書に組み込まれ、一部を構成する添付の図は、開示される組成物および方法を例示する記載と共にいくつかの実施形態を例示する。
本化合物、組成物、物品、デバイスおよび/または方法が開示および記載されるに先立ち、他に特に規定のない限り、それらが、特定の合成方法もしくは特定の組換えバイオテクノロジー法に、または他に特に規定のない限り具体的な試薬に限定されず、当然のことながら変動し得ることが理解される。本明細書において使用される用語は、具体的な実施形態を記載する目的のためだけであり、限定することを意図しないことも理解される。
明細書および添付の特許請求の範囲において使用される場合、単数形「a」、「an」および「the」は、文脈が他を明らかに示す場合を除いて、複数の指示物を含む。したがって、例えば「医薬用担体」への言及は、2つ以上のそのような担体の混合物を含む、など。
本明細書に記載されるものに類似のまたは等価の組成物、キット、細胞および方法は、本発明の実行または検査において使用され得るが、好適な組成物、キット、細胞および方法は、下に記載される。本明細書において述べられるすべての刊行物、特許出願および特許は、参照によりその全体が組み込まれる。例えば米国特許出願第14/349,918号明細書および米国特許第7,553,929号明細書は、参照によりその全体が組み込まれる。矛盾する場合は、定義を含む本明細書が支配する。下に論じられる具体的な実施形態は、例示のみであり、限定することを意図しない。
炎症と関連する疾患を治療するための本明細書に記載される組成物(例えば、医薬組成物)は、薬学的に許容される担体ならびに、これだけに限らないがNFκB、AP−1、NFAT、STAT1、ChREBPα、ChREBPβ、SREBP1a、SREBP1cおよびSREBP2が挙げられ、核輸送のためにインポーチンアルファおよび/またはベータを利用する少なくとも1つの転写因子の核への進入を変更する(例えば、減少させる)ため、ならびに疾患を治療または予防するために有効な量の少なくとも1つのインポーチンベータ選択的および/または少なくとも1つのインポーチンアルファ選択的NTMを含む。例えば、少なくとも1つのSREBPの核への進入は、低減される。上述の通り、NTMは、これだけに限らないが、インポーチンアルファおよびベータヘテロ二量体を利用するNFκB、AP−1、NFAT、STAT1、SREBP1a、核輸送のためにインポーチンベータだけを利用するSREBP1cおよびSREBP2を含む転写因子によって媒介される核へのシグナル伝達を調節する、一方でChREBPは核移行のために主にインポーチンアルファを利用できる。この例では、インポーチンベータ選択的NTMは、SREBP1a、SREBP1cおよびSREBP2の核形態の核移行を低減する。任意の好適なインポーチンベータ選択的NTMは使用され得る。インポーチンベータ選択的NTMの例として、これだけに限らないが、下の表3に列挙されるSSHRドメインおよび上の表2に列挙されるカーゴを含むペプチド配列が挙げられる。かかるインポーチンベータ選択的NTMの一例は、AAVALLPAVLLALLAPVQRDEQKLMP(配列番号40)(すなわち、AAVALLPAVLLALLAP(配列番号17)のSSHRドメインおよびVQRDEQKLMP(配列番号11)のカーゴを有するペプチド配列、下の表3に列挙の通り)である。ヘテロ二量体の形成のために必要なインポーチンアルファとインポーチンベータとの相互作用を阻害するように設計されたペプチドの追加的例として、AAVALLPAVLLALLAPRRRRIEVNVELRKAKK(配列番号18)(表3においてSIBBと称される)、AAVALLPAVLLALLAPRRRRIEVNVELRKAKKDD(配列番号19)(表3においてSI−1と称される)、AAVALLPAVLLALLAPRRQRNEVVVELRKNKRDE(配列番号20)(表3においてSI−3と称される)、AAVALLPAVLLALLAPRRHRNEVTVELRKNKRDE(配列番号21)(表3においてSI−4と称される)、AAVALLPAVLLALLAPRRRREEEGLQLRKQKREE(配列番号22)(表3においてSI−5と称される)、AAVALLPAVLLALLAPRRRREEEGIQLRKQKREQ(配列番号23)(表3においてSI−7と称される)およびAAVALLPAVLLALLAPCTEMRRRRIEVC(配列番号24)(表3においてcSIBと称される)が挙げられる。インポーチンアルファの特異的阻害剤であるように設計されたペプチドの例として、AAVALLPAVLLALLAPVELRKAKKDDQMLKRRNVSSF(配列番号25)(表3においてSAR1と称される)、AAVALLPAVLLALLAPVELRKNKRDEHLLKRRNVPHE(配列番号26)(表3においてSAR3と称される)、AAVALLPAVLLALLAPVELRKNKRDEHLLKKRNVPQE(配列番号27)(表3においてSAR4と称される)、AAVALLPAVLLALLAPLQLRKQKREEQLFKRRNVATA(配列番号28)(表3においてSAR5と称される)、AAVALLPAVLLALLAPIQLRKQKREQQLFKRRNVELI(配列番号29)(表3においてSAR7と称される)、AAVALLPAVLLALLAPCVELRKAKKDDQC(配列番号30)(表3においてcSAR1−Cと称される)、AAVALLPAVLLALLAPCVELRKNKRDEHC(配列番号31)(表3においてcSAR3−Cと称される)、AAVALLPAVLLALLAPCLQLRKQKREEQC(配列番号32)(表3においてcSAR5−Cと称される)、AAVALLPAVLLALLAPCIQLRKQKREQQC(配列番号33)(表3においてcSAR7−Cと称される)、AAVALLPAVLLALLAPCQMLKRRNVSSFC(配列番号34)(表3においてcSAR1−Nと称される)、AAVALLPAVLLALLAPCHLLKRRNVPHEC(配列番号35)(表3においてcSAR3−Nと称される)、AAVALLPAVLLALLAPCHLLKKRNVPQEC(配列番号36)(表3においてcSAR4−Nと称される)、AAVALLPAVLLALLAPCQLFKRRNVATAC(配列番号37)(表3においてcSAR5−Nと称される)およびAAVALLPAVLLALLAPCQLFKRRNVELIC(配列番号38)(表3においてcSAR7−Nと称される)が挙げられる。これらの配列の任意の誘導体および/または類似体が本発明によって包含されることが理解される。
一態様では、例えば、配列番号1、配列番号2、配列番号3;配列番号4;配列番号5;配列番号6、配列番号7、配列番号8、配列番号9、配列番号13、配列番号16、配列番号17、配列番号18、配列番号19;配列番号20;配列番号21;配列番号22、配列番号23、配列番号24、配列番号25、配列番号26、配列番号27、配列番号28、配列番号29;配列番号30;配列番号31;配列番号32、配列番号33、配列番号34、配列番号35、配列番号36、配列番号37、配列番号38、配列番号39;配列番号40;および/または配列番号41に記載される配列を含むNTMなどの1つまたは複数のNTMを含む組成物の治療有効量を対象に投与することを含む、対象において炎症性皮膚障害(例えば、微生物性炎症を誘導する微生物因子、自己免疫プロセス、自己炎症プロセス、代謝障害、新生物障害ならびに/または、炎症によって媒介される物理的要因および/もしくは物理的傷害によって生じる皮膚障害など、これだけに限らないが、接触性皮膚炎、乾癬、全身性エリテマトーデス、水疱性皮膚炎、「肉食性疾患」、脂漏性皮膚炎、アトピー性皮膚炎および移植片対宿主病が挙げられる)または皮膚傷害によって生じる炎症性応答を治療する/阻止する/低減する方法が本明細書において開示される。
多数の炎症性状態は、炎症(例えば、表皮剥脱、穿刺、裂傷、挫傷、鈍器外傷、虚血、出血性卒中、手術、移植、褥瘡、電撃熱傷、日焼け、化学熱傷、高温熱傷、低温熱傷、放射線損傷および皮膚老化など)によって媒介される物理的損傷から生じる。上記の通り、本明細書において開示されるNTMは、SRTFおよびSREBPを核に移行させ、シグナル伝達経路を制御する核輸送シャトル、Imp α5およびImp β1を標的化でき、結果的にゲノムリプログラミングを生じる。したがって、本明細書に記載の通り核移行を標的化する本明細書において開示される免疫治療の新規形態は、これらの物理的損傷に関連する炎症駆動性破壊を停止できる。したがって、一態様では、NTM(例えば、配列番号1、配列番号2、配列番号3;配列番号4;配列番号5;配列番号6、配列番号7、配列番号8、配列番号9、配列番号13、配列番号16、配列番号17、配列番号18、配列番号19;配列番号20;配列番号21;配列番号22、配列番号23、配列番号24、配列番号25、配列番号26、配列番号27、配列番号28、配列番号29;配列番号30;配列番号31;配列番号32、配列番号33、配列番号34、配列番号35、配列番号36、配列番号37、配列番号38、配列番号39;配列番号40;および/または配列番号41に記載される配列を含むNTM、NTMを含む組成物など)を含む組成物の治療有効量を物理的損傷を有する対象に投与することを含む、物理的損傷(例えば、表皮剥脱、穿刺、裂傷、挫傷、鈍器外傷、虚血、出血性卒中、手術、移植、日焼け、化学熱傷、高温熱傷、低温熱傷など)によって生じる炎症を治療する方法が本明細書において開示される。
哺乳動物対象における炎症性障害を治療するまたは予防する典型的な方法は、表2および3に列挙されるペプチドを含む、SSHRドメインおよびカーゴを含む少なくとも1つのインポーチンアルファ選択的NTMまたは少なくとも1つのインポーチンベータ選択的NTMを含む組成物を、哺乳動物対象に、少なくとも1つの転写因子のインポーチンアルファ−および/またはインポーチンベータ媒介核移行を低減し、哺乳動物対象における炎症を低減するために有効な量で投与することを含む。本明細書において開示される方法では、NTMは、炎症性ストレスに応答するSRTFのインポーチンアルファ媒介性核移行を低減する、ならびに/または代謝ストレスに応答する転写因子、例えばChREBPおよびSREBP転写因子のインポーチンアルファもしくはベータ媒介性核移行を、それぞれインポーチンアルファへのおよびインポーチンベータへの結合によって低減する。任意の好適なNTM、例えば本明細書において開示される配列、すなわち、配列番号1〜9、13および16〜41ならびに/またはこれらの誘導体および/もしくは類似体の1つまたは複数は使用され得る。組成物は、任意の好適な経路、例えば、経口、局所的、静脈内または皮下を介して投与され得る。一般に、本発明の治療方法は、哺乳動物、特にヒトを含むそれを必要とする対象(例えば、動物)への本明細書に記載される組成物の治療有効量の投与を含む。
対象(例えば、ヒト対象)における、これだけに限らないが微生物疾患、自己免疫疾患、自己炎症性障害、代謝障害、新生物障害または炎症によって媒介される物理的要因および/もしくは物理的傷害が挙げられる皮膚炎症障害(例えば、急性炎症、亜急性炎症、慢性炎症、器官特異的炎症、全身性炎症、および/もしくは敗血症など)、または微生物疾患、自己免疫疾患、自己炎症性障害、代謝障害、新生物障害または炎症によって媒介される物理的要因および/もしくは物理的傷害)によって生じる炎症性皮膚障害を治療するための本明細書に記載される組成物、例えば、医薬組成物は、これだけに限らないが、微生物疾患、自己免疫疾患、自己炎症性障害、代謝障害、新生物障害または炎症によって媒介される物理的要因および/もしくは物理的傷害によって生じる皮膚障害が挙げられる炎症障害(例えば、急性炎症、亜急性炎症、慢性炎症、器官特異的炎症、全身性炎症、および/または敗血症における電撃性紫斑など)を治療するために十分なNTM(cSN50、cSN50.1、cSN50.1ベータまたは配列番号3、配列番号4、配列番号5、配列番号6、配列番号7、配列番号8および/もしくは配列番号9に記載されるNTMなど)の治療有効量を含む。同様に、対象(例えば、ヒト対象)における皮膚炎症を治療するための本明細書に記載される組成物は、これだけに限らないが、微生物疾患、自己免疫疾患、自己炎症性障害、代謝障害、新生物障害または炎症によって媒介される物理的要因および/もしくは物理的傷害によって生じる皮膚障害が挙げられる炎症障害(例えば、急性炎症、亜急性炎症、慢性炎症、器官特異的炎症、全身性炎症、および/または敗血症など)を有する対象においてSRTFおよびSREBPの核レベルを低減するために十分なNTM(cSN50、cSN50.1、cSN50.1ベータまたは配列番号3、配列番号4、配列番号5、配列番号6、配列番号7、配列番号8、および/もしくは配列番号9に記載されるNTMなど)の治療有効量、ならびに薬学的に許容される担体を含む。
抗体を含む組成物は、薬学的に許容される担体との組合せで治療用に使用され得る。
組成物を投与するための有効な投薬量およびスケジュールは、経験的に決定することができ、かかる決定を行うことは、当業者の技術の範囲内である。組成物の投与のための投薬量範囲は、冒されている障害の症状において望ましい効果を生じるために十分に多いものである。投薬量は、望ましくない交差反応、アナフィラキシー反応などの有害な副作用を生じるほど多いべきではない。一般に、投薬量は、年齢、状態、性別および患者における疾患の程度、投与経路または他の薬物がレジメンに含まれているかどうかに応じて変動し、当業者によって決定され得る。投薬量は、任意の禁忌(counterindication)の事象において個々の医師によって調整され得る。投薬量は、変動する場合があり、1日または数日間、毎日1または複数用量の投与で投与されてよい。指針は、所与の種類の医薬品に関する好適な投薬量についての文献において見出すことができる。例えば、抗体についての好適な用量を選択するための指針は、抗体の治療用使用についての文献、例えば、Handbook of Monoclonal Antibodies, Ferrone et al., eds., Noges Publications, Park Ridge, N.J., (1985) ch. 22 and pp. 303-357; Smith et al., Antibodies in Human Diagnosis and Therapy, Haber et al., eds., Raven Press, New York (1977) pp. 365-389において見出すことができる。単独で使用される抗体の典型的な1日投薬量は、上に述べる要因に依存して、1日あたり約1μg/kg体重から100mg/kg体重以上の範囲であってよい。
本明細書において開示される遺伝子、タンパク質の任意の既知の変種および誘導体またはそれから生じ得るものを定義する1つの方法は、具体的な既知の配列に対する相同性の観点で変種および誘導体を定義することを通じてであることが理解される。例えば、配列番号2は、NTM(cSN50.1)の特定の配列を記載している。述べられた配列に少なくとも、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パーセント相同性を有する本明細書において開示されるこれらおよび他の遺伝子の変種ならびにタンパク質由来ペプチド配列は、具体的に開示される。当業者は、2つのタンパク質、ペプチドまたはタンパク質をコードする遺伝子などの核酸の相同性をどの様に決定するかを容易に理解する。例えば、相同性は、相同性がその最も高いレベルであるように2つの配列をアラインした後に算出され得る。本明細書において使用される場合、配列相同性は、配列同一性と互換的に使用される。
a)ペプチド変種
本明細書において論じられる通り、公知であり、本明細書において企図されるNTMの多数の変種がある。ペプチド変種および誘導体は、当業者に十分理解され、アミノ酸配列改変を含む場合がある。例えば、アミノ酸配列改変は、典型的には3つの種類の1つまたは複数に該当する:置換、挿入または欠失変種。挿入は、アミノおよび/またはカルボキシル末端融合ならびに単一または複数のアミノ酸残基の配列内挿入を含む。通常、挿入は、アミノまたはカルボキシル末端融合のものよりも小さな挿入であり、例えば1から4残基ほどである。欠失は、タンパク質配列からの1つまたは複数のアミノ酸残基の除去によって特徴付けられる。典型的には、約2から6残基未満がタンパク質分子内の任意の1つの部位で欠失される。通常、これらの変種は、タンパク質をコードするDNA中のヌクレオチドの部位特異的変異導入によって調製され、それにより変種をコードするDNAを産生し、その後、組換え細胞培養においてDNAを発現させる。既知の配列を有するDNA中の予め決定された部位に置換変異を作製するために技術は、周知である、例えばM13プライマー変異導入およびPCR変異導入。アミノ酸置換は、典型的には単一残基であるが、多数の異なる位置に一度に生じる場合もある;挿入は、通常、約1から10アミノ酸残基程度であり;欠失は、約1から30残基の範囲である。好ましくは欠失または挿入は、隣接する対、すなわち、2残基の欠失または2残基の挿入で作製される。置換、欠失、挿入またはその任意の組合せは、最終構築物に達するように組み合わされ得る。変異は、読み枠の範囲外の配列に位置付けられてはならず、好ましくはmRNA二次構造を産生できる相補性領域を創出しない。置換変種は、少なくとも1つの残基が除去されており、異なる残基がその場所に挿入されたものである。そのような置換は、一般に、以下の表4および5に従って作製され、保存的置換と称される。
以下の実施例は、当業者に、本明細書で特許請求される化合物、組成物、物品、デバイスおよび/または方法がどのように作製され、評価されるかの完全な開示および記載を提供するために述べられ、単に例示的であることが意図され、本開示を限定することを意図しない。数字(例えば、量、温度など)に関して正確さを確保する努力はなされたが、ある程度の誤差および偏差は説明されるべきである。他に示さない限り、割合は重量による、温度は℃であるまたは周囲温度である、圧力は大気圧であるまたはその付近である。
ホルボールミリストイルアセテート(PMA)の1日量を4回用いてチャレンジしたC57BL/6Jマウスの剪毛した背中への1日2回のNTM治療
a)試薬:
NTM(cSN50.1):使用直前に滅菌水100mg/ml中に再構成し、次に100%EtOHを用いて1.5mg/ml(低用量)または5mg/ml(高用量)に希釈。PMA(Calbiochem #524400):DMSO中で16.2mM(10mg/ml)保存、100%エタノール(EtOH)を用いて使用直前に100μMに希釈。PMAおよびNTMの両方について100%EtOHをビヒクル対照として投与。
8週齢メスC57BL/6Jマウスは、Jackson Labsから購入し、実験開始前に1週間気候順化させた。治療24時間前にマウスをイソフルランを用いて麻酔し、背中を剃毛した。4群に無作為化した:#1=ビヒクル対照;#2〜#4 PMA+高用量NTM;#5〜#7 PMA+低用量NTM;#8〜#10 PMA+ビヒクル。
20μlビヒクル(#1)または20μl中2nmole(1.25μg)PMA(#2〜#10)を各マウスの背中の2スポット、両方とも1cm直径、それぞれに1日1回、4日間連続で投与した。低用量NTM(30μg/20μl;#5〜#7)、高用量NTM(100μg/20μl;#2〜#4)またはビヒクル(#1、#8〜#10)を各マウスの背中の2スポット(20μl/スポット)、直径各1cmに、初回PMAチャレンジの1時間前およびその後、実験期間中12時間ごとに投与した。マウスを4回目のPMA治療1時間後に安楽死させ、2個の皮膚生検を各マウスから回収し:1個をホルマリンに1個を液体窒素中で即時凍結させ、−80℃で保存した。
NTMを用いて治療したC57BL/6J−129マウスの耳への単一PMAチャレンジ
a)試薬:
NTM(cSN50.1):使用直前に滅菌水中100mg/mlに再構成、次に100%EtOHを用いて5mg/mlに希釈。PMA(Calbiochem #524400):DMSO中16.2mM(10mg/ml)の保存液を100%エタノール(EtOH)を用いて使用直前に200μMに希釈。100%EtOHは、PMAおよびNTMの両方についてビヒクル対照として投与。
8〜9週齢メスC57BL/6J−129マウスを野生型対照として室内で飼育し、3群に無作為化した:#1〜#3=ビヒクル対照;#4〜#6=PMA+ビヒクル;#7〜#9=PMA+NTM。
20μlビヒクル(#1〜#3)または20μl中4nmole(2.5μg)PMA(#4〜#9)を各耳に、10μlを各側の耳に投与した。ビヒクル(#1〜#6)またはNTM(100μg/20μl;#7〜#9)を各耳に、10μlを各側の耳にPMAチャレンジ0.5時間前およびチャレンジ3時間、6時間および8時間後に投与した。耳の厚さの測定をベースラインおよびPMAチャレンジの3時間、6時間、8時間後および24時間後、治療前にMitutyoキャリパーを用いて各耳から得た。PMAチャレンジの8時間後に各マウスの左耳からそれぞれ3mm直径の3個のパンチ生検、PMAチャレンジの24時間後に右耳から3個を回収し:各1個をホルマリンに、2個を液体窒素中で即時凍結させ、−80℃で保存した。
利用可能な技術は、続く表から選択される:免疫組織化学/免疫蛍光:好中球浸潤を定量するための好中球マーカーおよび/またはミエロペルオキシダーゼ、他の細胞型特異的マーカー(例えば、マクロファージ、マスト細胞、TおよびBリンパ球)、増殖マーカー(例えば、PCNA、Ki67);サイトカイン/ケモカイン(例えば、TNFα、IL−1α、IL−1β、IL−6、MCP−1)もしくは他の炎症性メディエーター、ならびに/またはNF−κBおよび/または他の炎症性シグナル伝達タンパク質(例えば、リン酸化STAT3);凍結皮膚生検由来のRNA単離に続くサイトカイン/ケモカインまたは他の炎症性メディエーターおよびシグナル伝達タンパク質の定量的RT−PCR;皮膚生検可溶化液(全細胞および/または核抽出物)中のサイトカイン/ケモカインまたは他の炎症性メディエーターおよびシグナル伝達タンパク質の免疫ブロット分析;ならびに/またはELISA、サイトメトリービーズアレイ、放射免疫アッセイもしくは酵素アッセイによる皮膚生検可溶化液中のサイトカイン/ケモカインおよび他の炎症性メディエーター(例えば、ミエロペルオキシダーゼ、プロスタグランジンE2、ロイコトリエンB4)の直接測定。
Claims (28)
- 核輸送モディファイヤー(NTM)を含む組成物の治療有効量を対象に投与することを含む、前記対象における微生物性、アレルギー、自己免疫性、恒常的、代謝、新生物および物理的傷害によって生じる炎症性皮膚疾患または炎症性皮膚障害を治療する/阻止する/低減する方法。
- 前記NTMが、配列番号1、配列番号2、配列番号3;配列番号4;配列番号5;配列番号6、配列番号7、配列番号8、配列番号9、配列番号13、配列番号16、配列番号17、配列番号18、配列番号19;配列番号20;配列番号21;配列番号22、配列番号23、配列番号24、配列番号25、配列番号26、配列番号27、配列番号28、配列番号29;配列番号30;配列番号31;配列番号32、配列番号33、配列番号34、配列番号35、配列番号36、配列番号37、配列番号38、配列番号39;配列番号40;および/または配列番号41に記載される配列を含む、請求項1に記載の方法。
- 前記炎症性皮膚疾患または炎症性皮膚障害が、微生物因子、自己免疫プロセス、アレルゲン、自己炎症プロセス、代謝プロセス、新生物/発癌プロセス、または炎症によって媒介される物理的傷害によって生じる、請求項1に記載の方法。
- 前記炎症性皮膚疾患が、微生物感染によって生じる、請求項3に記載の方法。
- 前記対象に抗菌剤を投与することをさらに含む、請求項4に記載の方法。
- 前記NTM組成物が、抗菌剤を含む、請求項5に記載の方法。
- 前記微生物性傷害がウイルス感染によって生じる、請求項4に記載の方法。
- 前記ウイルス感染が、単純ヘルペスウイルス−1、単純ヘルペスウイルス−2、水痘帯状疱疹ウイルス、エプスタイン・バーウイルス、サイトメガロウイルス、ヒトヘルペスウイルス−6、痘瘡ウイルス、水疱性口内炎ウイルス、A型肝炎ウイルス、B型肝炎ウイルス、C型肝炎ウイルス、D型肝炎ウイルス、E型肝炎ウイルス、ライノウイルス、コロナウイルス、A型インフルエンザウイルス、B型インフルエンザウイルス、麻疹ウイルス、ポリオーマウイルス、ヒトパピローマウイルス、呼吸器多核体ウイルス、アデノウイルス、コクサッキーウイルス、デングウイルス、流行性耳下腺炎ウイルス、ポリオウイルス、狂犬病ウイルス、ラウス肉腫ウイルス、レオウイルス、黄熱ウイルス、ジカウイルス、エボラウイルス、マールブルグウイルス、ラッサ熱ウイルス、東部ウマ脳炎ウイルス、日本脳炎ウイルス、セントルイス脳炎ウイルス、マレー渓谷熱ウイルス、西ナイルウイルス、リフトバレー熱ウイルス、A群ロタウイルス、B群ロタウイルス、C群ロタウイルス、シンドビスウイルス、サル免疫不全ウイルス、1型ヒトT細胞白血病ウイルス、ハンタウイルス、風疹ウイルス、サル免疫不全ウイルス、1型ヒト免疫不全ウイルスおよび2型ヒト免疫不全ウイルスからなる群から選択されるウイルスの感染である、請求項7に記載の方法。
- 前記微生物性傷害が、細菌感染によって生じ;前記細菌感染を生じさせる細菌が炭疽菌(Bacillus anthracis)ではない、請求項4に記載の方法。
- 前記細菌感染が、結核菌(Mycobacterium tuberculosis)、マイコバクテリウム・ボビス(Mycobacterium bovis)、マイコバクテリウム・ボビス(Mycobacterium bovis)BCG株、BCG亜株、マイコバクテリウム・アビウム(Mycobacterium avium)、マイコバクテリウム・イントラセルラー(Mycobacterium intracellular)、マイコバクテリウム・アフリカヌム(Mycobacterium africanum)、マイコバクテリウム・カンサシ(Mycobacterium kansasii)、マイコバクテリウム・マリヌム(Mycobacterium marinum)、マイコバクテリウム・ウルセランス(Mycobacterium ulcerans)、ヨーネ菌(Mycobacterium avium subspecies paratuberculosis)、ライ菌(Mycobacterium leprae)、ノカルジア・アステロイデス(Nocardia asteroides)、他のノカルジア種、在郷軍人病菌(Legionella pneumophila)、他のレジオネラ種、アシネトバクター・バウマニ(Acinetobacter baumanii)、チフス菌(Salmonella typhi)、サルモネラ・エンテリカ(Salmonella enterica)、他のサルモネラ種、シゲラ・ボイディ(Shigella boydii)、志賀赤痢菌(Shigella dysenteriae)、シゲラ・ソネイ(Shigella sonnei)、シゲラ・フレックスネリ(Shigella flexneri)、他のシゲラ種、ペスト菌(Yersinia pestis)、パスツレラ・ヘモリチカ(Pasteurella haemolytica)、パスツレラ・マルトシダ(Pasteurella multocida)、他のパスツレラ種、アクチノバチルス・プルロニューモニア(Actinobacillus pleuropneumoniae)、リステリア菌(Listeria monocytogenes)、リステリア・イバノビイ(Listeria ivanovii)、ブルセラ・アボルタス(Brucella abortus)、他のブルセラ種、コウドリア・ルミナンチウム(Cowdria ruminantium)、ライム病ボレリア(Borrelia burgdorferi)、ボルデテラ・アビウム(Bordetella avium)、百日咳菌(Bordetella pertussis)、ボルデテラ・ブロンキセプチカ(Bordetella bronchiseptica)、ボルデテラ・トレマツム(Bordetella trematum)、ボルデテラ・ヒンジイ(Bordetella hinzii)、ボルデテラ・プテリ(Bordetella pteri)、パラ百日咳菌(Bordetella parapertussis)、ボルデテラ・アンソルピイ(Bordetella ansorpii)、他のボルデテラ種、鼻疽菌(Burkholderia mallei)、類鼻疽菌(Burkholderia psuedomallei)、セパシア菌(Burkholderia cepacia)、肺炎クラミジア(Chlamydia pneumoniae)、クラミジア・トラコーマ(Chlamydia trachomatis)、オウム病クラミジア(Chlamydia psittaci)、Q熱コクシエラ(Coxiella burnetii)、リケッチア種、エールリッヒア種、黄色ブドウ球菌(Staphylococcus aureus)、表皮ブドウ球菌(Staphylococcus epidermidis)、肺炎球菌(Streptococcus pneumoniae)、化膿性連鎖球菌(Streptococcus pyogenes)、ストレプトコッカス・アガラクチア(Streptococcus agalactiae)、大腸菌(Escherichia coli)、コレラ菌(Vibrio cholerae)、ビブリオ・バルニフィカス(Vibrio vulnificus)、キャプノサイトファーガ・カニモルサス(Capnocytophaga canimorsus)、カンピロバクター種、髄膜炎菌(Neisseria meningitides)、ナイセリア・ゴノーレア(Neisseria gonorrhea)、緑膿菌(Pseudomonas aeruginosa)、他のシュードモナス種、インフルエンザ菌(Haemophilus influenzae)、軟性下疳菌(Haemophilus ducreyi)、他のヘモフィルス種、破傷風菌(Clostridium tetani)、他のクロストリジウム種、エルシニア・エンテロリチカ(Yersinia enterolitica)、および他のエルシニア種からなる群から選択される細菌の感染である、請求項9に記載の方法。
- 前記微生物性傷害が真菌感染によって生じる、請求項4に記載の方法。
- 前記真菌感染が、マラセチア種、カンジダ・アルビカンス(Candida albicans)、クリプトコッカス・ネオフォルマンス(Cryptococcus neoformans)、ヒストプラズマ・カプスラーツム(Histoplasma capsulatum)、アスペルギルス・フミガーツス(Aspergillus fumigatus)、コクシジオイデス・イミチス(Coccidiodes immitis)、パラコクシジオイデス・ブラジリエンシス(Paracoccidiodes brasiliensis)、ブラストミセス・デルミチジス(Blastomyces dermitidis)、ニューモシスチス・カリニ(Pneumocystis carnii)、ニューモシスチス・ジロベシ(Pneumocystis jirovecii)、ペニシリウム・マルネッフィ(Penicillium marneffi)およびアルテルナリア・アルテナータ(Alternaria alternata)からなる群から選択される真菌の感染である、請求項11に記載の方法。
- 前記微生物性傷害が、寄生虫感染によって生じる、請求項4に記載の方法。
- 前記寄生虫感染が、トキソプラズマ原虫(Toxoplasma gondii)、熱帯熱マラリア原虫(Plasmodium falciparum)、三日熱マラリア原虫(Plasmodium vivax)、四日熱マラリア原虫(Plasmodium malariae)、他のマラリア原虫種、赤痢アメーバ(Entamoeba histolytica)、ネグレリア・フォーレリ(Naegleria fowleri)、リノスポリジウム・セーベリ(Rhinosporidium seeberi)、ランブル鞭毛虫(Giardia lamblia)、蟯虫(Enterobius vermicularis)、エンテロビウス・グレゴリイ(Enterobius gregorii)、ヒト回虫(Ascaris lumbricoides)、ズビニ鉤虫(Ancylostoma duodenale)、アメリカ鉤虫(Necator americanus)、クリプトスポリジウム種、トリパノソーマ・ブルセイ(Trypanosoma brucei)、トリパノソーマ・クルージ(Trypanosoma cruzi)、森林型熱帯リーシュマニア(Leishmania major)、他のリーシュマニア種、ジフィロボスリウム・ラツム(Diphyllobothrium latum)、小型条虫(Hymenolepis nana)、縮小条虫(Hymenolepis diminuta)、単包条虫(Echinococcus granulosus)、多包条虫(Echinococcus multilocularis)、エキノコッカス・ボゲリ(Echinococcus vogeli)、ヤマネコ包条虫(Echinococcus oligarthrus)、ジフィロボスリウム・ラツム(Diphyllobothrium latum)、肝吸虫(Clonorchis sinensis);クロノルキス・ベリニ(Clonorchis viverrini)、肝蛭(Fasciola hepatica)、ファシオラ・ギガンチカ(Fasciola gigantica)、槍形吸虫(Dicrocoelium dendriticum)、肥大吸虫(Fasciolopsis buski)、横川吸虫(Metagonimus yokogawai)、タイ肝吸虫(Opisthorchis viverrini)、ネコ肝吸虫(Opisthorchis felineus)、肝吸虫(Clonorchis sinensis)、トリコモナス原虫(Trichomonas vaginalis)、アカントアメーバ種、シストーマ・インターカラタム(Schistosoma intercalatum)、ビルハルツ住血吸虫(Schistosoma haematobium)、日本住血吸虫(Schistosoma japonicum)、マンソン住血吸虫(Schistosoma mansoni)、他のシストソーマ種、糞線虫(Strongyloides stercoralis)、トリコビルハルジア・レゲンチ(Trichobilharzia regenti)、旋毛虫(Trichinella spiralis)、トリキネラ・ブリトビ(Trichinella britovi)、トリキネラ・ネルソニ(Trichinella nelsoni)、トリキネラ・ナティバ(Trichinella nativa)および赤痢アメーバ(Entamoeba histolytica)からなる群から選択される寄生虫の感染である、請求項13に記載の方法。
- 前記炎症性皮膚疾患が自己免疫または自己炎症プロセスによって生じる、請求項3に記載の方法。
- 前記自己免疫または自己炎症的原因が、接触性皮膚炎、家族性地中海熱、移植片対宿主病、天疱瘡、乾癬、酒さ、強皮症、全身性エリテマトーデス、アカラシア、急性散在性脳脊髄炎、急性運動性軸索型ニューロパチー、アジソン病、有痛脂肪症、成人スティル病、無ガンマグロブリン血症、円形脱毛症、アルツハイマー病、アミロイドーシス、強直性脊椎炎、抗GBM/抗TBM腎炎、抗リン脂質症候群、再生不良性貧血、自己免疫性血管浮腫、自己免疫性自律神経障害、自己免疫性脳脊髄炎、自己免疫性腸疾患、自己免疫性溶血性貧血、自己免疫性肝炎、自己免疫性内耳疾患(AIED)、自己免疫性心筋炎、自己免疫性卵巣炎、自己免疫性精巣炎、自己免疫性膵炎、多腺性自己免疫症候群、自己免疫性網膜症、自己免疫性蕁麻疹、軸索および神経ニューロパチー(AMAN)、バロー疾患、ベーチェット病、良性粘膜類天疱瘡、ビッカースタッフ脳炎、水疱性類天疱瘡、キャッスルマン病(CD)、セリアック病、シャーガス病、慢性疲労症候群、慢性炎症性脱髄性多発ニューロパチー(CIDP)、慢性再発性多巣性骨髄炎(CRMO)、チャーグ・ストラウス症候群(CSS)、好酸球性肉芽腫(EGPA)、瘢痕性類天疱瘡、コーガン症候群、寒冷凝集素病、先天性心ブロック、コクサッキー心筋炎、CREST症候群、クローン病、疱疹状皮膚炎、皮膚筋炎、デビック病(視神経脊髄炎)、1型糖尿病、円板状ループス、ドレスラー症候群、子宮内膜症、腱付着部炎、好酸球性食道炎(EoE)、好酸球性筋膜炎、結節性紅斑、本態性混合型クリオグロブリン血症、エヴァンス症候群、フェルティ症候群、線維筋痛症、線維性肺胞症、巨細胞性動脈炎(側頭動脈炎)、巨細胞性心筋炎、糸球体腎炎、グッドパスチャー症候群、多発血管炎性肉芽腫症、グレーブス病、ギランバレー症候群、橋本脳症、橋本甲状腺炎、溶血性貧血、ヘノッホ・シェーンライン紫斑病(HSP)、妊娠ヘルペスまたは妊娠性類天疱瘡(PG)、化膿性汗腺炎(HS)(反対型アクネ)、低ガンマグロブリン血症、IgA腎症、IgG4関連硬化性疾患、免疫性血小板減少性紫斑病(ITP)、封入体筋炎(IBM)、間質性膀胱炎(IC)、炎症性腸疾患(IBD)、若年性関節炎、若年性糖尿病(1型糖尿病)、若年性筋炎(JM)、川崎病、ランバート・イートン症候群、白血球破壊性血管炎、扁平苔癬、硬化性苔癬、木質性結膜炎、直鎖状IgA疾患(LAD)、ループス腎炎、ループス血管炎、慢性ライム病、メニエール病、顕微鏡的多発血管炎(MPA)、混合性結合組織病(MCTD)、モーレン潰瘍、ムッハ・ハーベルマン病、多巣性運動ニューロパチー(MMN)またはMMNCB、多発性硬化症、重症筋無力症、筋炎、ナルコレプシー、新生児ループス、視神経脊髄炎、好中球減少症、眼部瘢痕性類天疱瘡、視神経炎、オード甲状腺炎(Ord's thyroiditis)、回帰性リウマチ(PR)、PANDAS、傍腫瘍性小脳変性症(PCD)、発作性夜間ヘモグロビン尿症(PNH)、パリー・ロンベルグ症候群、毛様体扁平部炎(抹消ブドウ膜炎)、パーソネージ・ターナー(Parsonage-Turner)症候群、天疱瘡、抹消ニューロパチー、静脈周囲脳脊髄炎、悪性貧血(PA)、POEMS症候群、結節性多発動脈炎、多腺性症候群I、II、III型、リウマチ性多発筋痛症、多発性筋炎、心筋梗塞後症候群、心膜切開後症候群、原発性胆汁性肝硬変、原発性硬化性胆管炎、プロゲステロン皮膚炎、乾癬、乾癬性関節炎、赤芽球ろう(PRCA)、壊疽性膿皮症、レイノー症状、反応性関節炎、反射性交感神経性ジストロフィー、再発性多発軟骨炎、ムズムズ脚症候群(RLS)、後腹膜線維症、リウマチ熱、関節リウマチ、リウマチ性血管炎、サルコイドーシス、シュミット症候群、シュニッツラー症候群、強膜炎、強皮症、シェーグレン症候群、精子および精巣自己免疫、全身硬直症候群(SPS)、亜急性細菌性心内膜炎(SBE)、スザック症候群、シデナム舞踏病、交感性眼炎(SO)、全身性エリテマトーデス、全身性強皮症、高安動脈炎、側頭動脈炎/巨細胞性動脈炎、血栓性血小板減少性紫斑病(TTP)、トロサ・ハント症候群(THS)、横断性脊髄炎、1型糖尿病、潰瘍性大腸炎(UC)、未分化結合組織病(UCTD)、じん麻疹、じん麻疹様血管炎、ブドウ膜炎、血管炎、白斑、フォークト・小柳・原田病ならびにウェゲナー肉芽腫症(または多発血管炎性肉芽腫症(GPA))からなる群から選択される、請求項15に記載の方法。
- 前記炎症性皮膚疾患が、自己免疫または自己炎症プロセスによって生じる、請求項3に記載の方法。
- 前記自己免疫または自己炎症プロセスが、アトピー性皮膚炎/湿疹、ツタウルシ、オークおよびヌルデを含む接触性皮膚炎、薬物過敏反応、虫刺症、移植片対宿主病、移植片拒絶、家族性寒冷自己炎症性症候群(FCAS)、マックル・ウェルズ症候群(MWS)、新生児期発症多臓器性炎症性疾患(NOMID)(慢性小児神経皮膚関節症候群(CINCA)としても公知)、家族性地中海熱(FMF)、腫瘍壊死因子(TNF)関連周期性症候群(TRAPS)、TNFRSF11A関連遺伝性熱疾患(TRAPS11)、周期熱症候群を伴う高グロブリンD血症(HIDS)、メバロン酸酸性尿症(MA)、メバロン酸キナーゼ欠損症(MKD)、インターロイキン−1β(IL−1β)受容体アンタゴニスト(DIRA)の欠損症(骨髄炎、無菌性多巣性骨膜炎膿疱症としても公知)、マジード症候群、慢性非細菌性骨髄炎(CNO)、早期発症型炎症性腸疾患、憩室炎、インターロイキン−36受容体アンタゴニストの欠損症(DITRA)、家族性乾癬(PSORS2)、膿疱性乾癬(15)、化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群(PAPA)、免疫不全、熱および発達遅延を伴う先天性鉄芽球性貧血(SIFD)、小児肉芽腫性関節炎(PGA)、家族性ベーチェット様自己炎症性症候群、NLRP12関連周期熱症候群、プロテアソーム関連自己炎症性症候群(PRAAS)、免疫調節不全を伴う脊椎内軟骨異形成(SPENCDI)、乳児期発症STING関連脈管障害(SAVI)、アイカルディ・グティエール症候群、急性熱性好中球性皮膚症、X連鎖家族性血球貪食性リンパ組織球症およびLynキナーゼ関連自己炎症性疾患(LAID)からなる群から選択される、請求項17に記載の方法。
- 前記炎症性皮膚疾患が代謝プロセス/傷害によって生じる、請求項3に記載の方法。
- 前記代謝プロセスが、痛風、皮膚老化、黄色板腫、代謝症候群、糖尿病、肥満、ゴーシェ病、フェニルケトン尿症(PKU)、メープルシロップ尿症(MSUD)、脂肪肝、高コレステロール血症、高トリグリセリド血症、甲状腺機能亢進症、甲状腺機能低下症、脂質異常症、低脂血症およびガラクトース血症からなる群から選択される、請求項19に記載の方法。
- 代謝性皮膚障害が、脂漏性皮膚炎から選択される、請求項3に記載の方法。
- 前記炎症性皮膚障害が、新生物性皮膚障害によって生じる、請求項3に記載の方法。
- 前記新生物性皮膚障害応答が、菌状息肉症、セザリー症候群、カポジ肉腫、成人T細胞白血病/リンパ腫、PTEN過誤腫症候群、家族性大腸腺腫症、結節性硬化症、フォンヒッペル・リンダウ症候群、卵巣奇形腫、髄膜腫、骨軟骨腫、B細胞リンパ腫、T細胞リンパ腫、ホジキン病、骨髄性白血病、膀胱がん、脳がん、神経系がん、頭頸部がん、頭頸部の扁平上皮細胞癌、小細胞肺がんおよび非小細胞肺がんなどの肺がん、神経芽細胞腫/神経膠芽腫、卵巣がん、皮膚がん、肝臓がん、メラノーマ、口腔、咽頭、喉頭および肺の扁平上皮細胞癌、子宮頸がん、子宮頸癌、乳がん、および上皮がん、腎がん、泌尿生殖器がん、肺がん(pulmonary cancer)、食道癌、頭頸部癌、大腸がん、造血器がん;精巣がん;結腸がん、直腸がん、前立腺がんならびに膵臓がんからなる群から選択される、請求項21に記載の方法。
- 前記炎症性皮膚障害が物理的損傷によって生じる、請求項3に記載の方法。
- 前記炎症性傷害が、表皮剥脱、穿刺、裂傷、挫傷、鈍器外傷、虚血、手術、移植後移植片対宿主病、褥瘡、電撃熱傷、日焼け、化学熱傷、高温熱傷、低温熱傷、放射線損傷および皮膚老化からなる群から選択される、請求項24に記載の方法。
- 核輸送モディファイヤー(NTM)および抗菌剤を含む組成物の治療有効量に創傷を接触させることを含む、前記創傷を治療する方法。
- 核輸送モディファイヤー(NTM)を含む組成物の治療有効量に創傷を接触させることを含む、前記創傷の治癒にかかる時間を低減する方法。
- 核輸送モディファイヤー(NTM)を含む組成物の治療有効量を含む薬用粘着包帯、創傷被覆材、手術用ドレープ、縫合糸、膏薬、クリームまたは創傷接着剤。
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US20130089528A1 (en) * | 2011-10-06 | 2013-04-11 | Vanderbilt University | Compositions and methods for preserving insulin-producing cells and insulin production and treating diabetes |
WO2013052813A1 (en) * | 2011-10-06 | 2013-04-11 | Vanderbilt University | Compositions and methods for treating and preventing hyperlipidemia, fatty liver, atherosclerosis and other disorders associated with metabolic syndrome |
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