JP4717349B2 - 細胞の除去又は破壊を必要とする腫瘍及び他の状態の治療に有効なペプチド - Google Patents
細胞の除去又は破壊を必要とする腫瘍及び他の状態の治療に有効なペプチド Download PDFInfo
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Description
1.発明の分野
本発明は、細胞要素の除去又は破壊を必要とする、ヒトの良性又は悪性腫瘍のような状態を、神経糸タンパク質(neural thread protein)のアミノ酸配列の一部に対応する、類似する又は相同なアミノ酸配列を含むペプチドに基づく化合物を用いて治療する方法に関する。本発明の方法は、該化合物を、単独で又は担体に複合させて、筋肉内、経口、静脈内、くも膜下、腫瘍内、鼻腔内、局所、経皮などに投与することを含むが、これらに限定されない。
多くの医学的治療及び処置の本質は、有害又は不要な組織を除去又は破壊することである。そのような意義ある治療の例は、癌腫の外科的除去、化学療法による転移性腫瘍の破壊、及び腺(例えば前立腺)過形成の縮小などである。他の例は、不要な顔毛の除去、いぼの除去、及び不要な脂肪組織の除去を含む。
がんとは細胞の制御されない成長及び複製をもたらす、細胞の内部調節機構の異常である。正常細胞が組織を構成するが、これらの細胞が、特定化され、制御され、調和された単位としてふるまう能力を失うと(脱分化)、その欠陥によって細胞集団内の秩序が失われる。こうなったときに腫瘍が形成される。
本発明は、AD7c−NTP以外の神経糸タンパク質の他の種のアミノ酸配列の一部に対応するアミノ酸配列を含有するペプチドは、不要な細胞増殖物を治療及び/又は殺すことができるという発見を一部前提にしている。これらの不要な細胞増殖物は、特に、良性及び悪性腫瘍、腺(例えば前立腺)過形成,不要な顔毛、いぼ、及び不要な脂肪組織などである。
前述の一般的説明と以下の詳細な説明はいずれも例示及び説明的なものであり、クレームした本発明をさらに説明するために提供されるものである。他の目的、利点、及び特徴は以下の本発明の詳細な説明から当業者には容易に明らかであろう。
好ましい態様の詳細な説明
本発明のタンパク質、ヌクレオチド配列、ペプチドなど、及び方法を説明する前に、本発明は、記載した特定の方法論、プロトコル、細胞系、ベクター、及び試薬に制限されないことを理解すべきである(これらは変動しうるものである)。また、本明細書中で使用している用語は、特定の態様を説明することだけを目的としたもので、本発明の範囲を制限する意図はないことも理解すべきである。本発明の範囲は添付のクレームによってのみ制限される。
本記述全体を通じて、“a”、“an”、及び“the”で示される単数形は、文脈が明らかに他の場合を指していない限りは複数形への言及も含まれる。従って、“1個の宿主細胞”への言及は複数のそのような宿主細胞を含み、“1個の抗体”と言うときには1個以上の抗体及び当業者に公知のその等価物への言及も含む、といったことなどである。
(a)神経糸タンパク質の〜42、〜26、〜21、〜17、〜14、及び〜8kD種で、米国特許第5,948,634号、5,948,888号、5,830,670号、及び6,071,705号、並びにde la Monteら、J.Neuropathol.Exp.Neurol.,55(10):1038−50(1996)、de la Monteら、J.Neurol.Sci.,138(1−2):26−35(1996);de la Monteら、J.Neurol.Sci.,135(2):118−25(1996);de la Monteら、J.Clin.Invest.,100:3093−3104(1997);及びde la Monteら、Alz..Rep.,2:327−332(1999)に記載のもの;
(b)バージニア州マナッサスのAmerican Type Culture Collectionにアクセッション番号HB−12546で寄託されているモノクロナール抗体#2又はバージニア州マナッサスのAmerican Type Culture Collectionにアクセッション番号HB−12545で寄託されているモノクロナール抗体#5によって特異的に認識されるタンパク質;
(c)AD7c−NTP遺伝子によってコードされるタンパク質、スプライス変異体を含む;
(d)米国特許第5,830,670号、5,948,634号、及び5,948,888号の配列40に記載の、及びNCBI Entrez−タンパク質アクセッション番号AAE25447、PID g10048540に掲載の122アミノ酸神経糸タンパク質、これのアミノ酸配列を図1に示す(“NTP[122]”);
(e)NCBI Entrez−タンパク質アクセッション番号XP 032307、PID g14725132に掲載の112アミノ酸神経糸タンパク質、これのアミノ酸配列を図2に示す(“NTP[112]”);
(f)NCBI Entrez−タンパク質アクセッション番号AAH14951、PID g15928971に掲載の106アミノ酸神経糸タンパク質様タンパク質、これのアミノ酸配列を図3に示す(“NTP[106]”);
(g)米国特許第5,830,670号、5,948,634号、及び5,948,888号の配列30に記載の、及びNCBI Entrez−タンパク質アクセッション番号AAE25445、PID g10048538に掲載の98アミノ酸神経糸タンパク質、これのアミノ酸配列を図4に示す(“NTP[98]”);
(h)米国特許第5,830,670号、5,948,634号、及び5,948,888号の配列48に記載の、及びNCBI Entrez−タンパク質アクセッション番号AAE25448、PID g10048541に掲載の75アミノ酸神経糸タンパク質、これのアミノ酸配列を図5に示す(“NTP[75]”);
(i)米国特許第5,830,670号、5,948,634号、及び5,948,888号の配列36に記載の、及びNCBI Entrez−タンパク質アクセッション番号AAE25446、PID g10048539に掲載の68アミノ酸神経糸タンパク質、これのアミノ酸配列を図6に示す(“NTP[68]”);
(j)NCBI Entrez−タンパク質アクセッション番号AAH02534、PID g12803421に掲載の61アミノ酸神経糸タンパク質様タンパク質、これのアミノ酸配列を図7に示す(“NTP[61]”);
(k)膵臓糸タンパク質;
(l)米国特許第6,071,705に記載の神経膵臓糸タンパク質(nPTP);及び
(m)American Type Culture Collectionに寄託されているHB9934、HB9935、及びHB9936からなる群由来のハイブリドーマによって産生される抗体によって特異的に認識されるタンパク質;
を含むが、これらに限定されない。
“リバース−Dペプチド”という用語は、NTPペプチドのL−アミノ酸配列と比べて、逆の順に配列されたD−アミノ酸からなる生物学的に活性なタンパク質又はペプチドのことをいう。従って、L−アミノ酸のNTPペプチドのカルボキシ末端残基が、D−アミノ酸ペプチドのアミノ末端になる、などである。例えば、NTPペプチド、ETESHは、HdSdEdTdEdになる。Ed、Hd、Sd、及びTdは、それぞれL−アミノ酸のE、H、S、及びTに対応するD−アミノ酸である。
好適なNTPペプチドは、図1に記載の122アミノ酸配列のNTP(NTP[122])又は図2に記載の112アミノ酸配列のNTP(NTP[112])のアミノ酸配列から誘導される。しかしながら、NTP[122]又はNTP[112]と同じファミリーの他の分子の部分又はフラグメントに基づく他のNTPペプチド、例えば他の神経糸タンパク質、又は図3〜7に示したもののいずれか、及び膵臓糸タンパク質の使用も本発明の範囲に包含される。さらに、本発明は、NTPペプチドを全部又は一部含有する他のタンパク質(それによって該タンパク質は好ましくはNTPペプチドと同じ、類似した、又は増大した生物活性を有する)も含む。
NTP[122]ペプチド#1[配列番号8]、NTP[122]p106−122
NTP[112]ペプチド#1[配列番号16]、NTP[112]p1−15
NTP[106]ペプチド#1[配列番号23]、NTP[106]p1−15
NTP[98]ペプチド#1[配列番号30]、NTP[98]p1−15
NTP[75]ペプチド#1[配列番号36]、NTP[75]p1−15
NTP[68]ペプチド#1[配列番号41]、NTP[68]p1−15
NTP[61]ペプチド#1[配列番号45]、NTP[61]p1−15
本発明の組成物中の活性成分の実際の用量レベルは、特定の組成物及び投与法にとって所望の治療的応答を得るのに有効な量のNTPペプチドを得るために、変動しうる。従って、選択される用量レベルは、所望の治療効果、投与経路、所望の治療期間、及び他の要因によって決まる。
本実施例の目的は、注射部位の組織に及ぼすNTP[122]ペプチド#1の影響を測定することであった。
本実施例の目的は、注射部位の組織に及ぼすNTP[112]ペプチド#1の影響を測定することであった。
結果:上記実施例1と同様、NTP[112]ペプチド#1の注射は、72時間の時点で前立腺に顕著な細胞喪失及び萎縮を生じた。対照は最小の変化を示すか無変化で、針による軽度の局所的炎症であった。
本実施例の目的は、注射部位の組織に及ぼす前述のNTPペプチドの影響を測定することであった。
同様の対照ラット群に、(1)生理食塩水中ウシ血清アルブミン0.1%、(2)正常ヒト血清、(3)生理食塩水、(4)非感染性細菌タンパク質、及び(5)対照ペプチドを注射し、清浄化してから前述のように試験し安楽死させた。切除した注射巣は前述のように処置した。
Claims (25)
- a)配列番号9:(Met-Met-Val-Cys-Trp-Asn-Arg-Phe-Gly-Lys-Trp-Val-Tyr-Phe-Ile)のアミノ酸配列;
b)配列番号10:(Ser-Ala-Ile-Phe-Asn-Phe-Gly-Pro-Arg-Tyr-Leu-Tyr-His-Gly-Val)のアミノ酸配列;
c)配列番号11:(Pro-Phe-Tyr-Phe-Leu-Ile-Leu-Val-Arg-Ile-Ile-Ser-Phe-Leu-Ile)のアミノ酸配列;
d)配列番号12:(Gly-Asp-Met-Glu-Asp-Val-Leu-Leu-Asn-Cys-Thr-Leu-Leu-Lys-Arg)のアミノ酸配列;
e)配列番号13:(Ser-Ser-Arg-Phe-Arg-Phe-Trp-Gly-Ala-Leu-Val-Cys-Ser-Met-Asp)のアミノ酸配列;
f)配列番号14:(Ser-Cys-Arg-Phe-Ser-Arg-Val-Ala-Val-Thr-Tyr-Arg-Phe-Ile-Thr)のアミノ酸配列;
g)配列番号15:(Leu-Leu-Asn-Ile-Pro-Ser-Pro-Ala-Val-Trp-Met-Ala-Arg-Asn-Thr)のアミノ酸配列;
からなる群より選択されるアミノ酸配列からなるNTPペプチド。 - 請求項1に記載の1個以上のペプチドを含む医薬組成物。
- 請求項1に記載のペプチドに対応するアミノ酸配列をコードする核酸。
- 請求項3に記載の1個以上の核酸を含む医薬組成物。
- 細胞の除去又は破壊を必要とする哺乳動物における状態の治療するための医薬組成物であって、請求項1に記載のペプチドを含む、前記医薬組成物。
- 前記ペプチドが、経口、皮下、皮内、鼻腔内、静脈内、筋肉内、くも膜下、腫瘍内、局所、及び経皮からなる群から選ばれる方法によって投与される、請求項5に記載の医薬組成物。
- 外科的切除、臓器移植、組織移植、化学療法、免疫療法、ワクチン接種、熱又は電気的剥離、寒冷療法、レーザー療法、光線療法、遺伝子療法、及び放射線からなる群から選ばれる治療法による前記哺乳動物の治療の前、中、後に投与される、請求項5に記載の医薬組成物。
- 前記状態が、肺、乳房、胃、膵臓、前立腺、膀胱、骨、卵巣、皮膚、腎臓、洞、結腸、腸、胃、直腸、食道、心臓、脾臓、唾液腺、血液、脳及びその外皮、脊髄及びその外皮、筋肉、結合組織、副腎、副甲状腺、甲状腺、子宮、精巣、脳下垂体、生殖器官、肝臓、胆嚢、眼、耳、鼻、咽頭、扁桃、口、及びリンパ節並びにリンパ系からなる群から選ばれる組織の良性又は悪性腫瘍である、請求項5に記載の医薬組成物。
- 前記状態が、肺、乳房、胃、膵臓、前立腺、膀胱、骨、卵巣、皮膚、腎臓、洞、結腸、腸、胃、直腸、食道、心臓、脾臓、唾液腺、血液、脳及びその外皮、脊髄及びその外皮、筋肉、結合組織、副腎、副甲状腺、甲状腺、子宮、精巣、脳下垂体、生殖器官、肝臓、胆嚢、眼、耳、鼻、咽頭、扁桃、口、及びリンパ節並びにリンパ系からなる群から選ばれる組織の過形成、肥大、又は過成長である、請求項5に記載の医薬組成物。
- 前記状態が、肺、乳房、胃、膵臓、前立腺、膀胱、骨、卵巣、皮膚、腎臓、洞、結腸、腸、胃、直腸、食道、心臓、脾臓、唾液腺、血液、脳及びその外皮、脊髄及びその外皮、筋肉、結合組織、副腎、副甲状腺、甲状腺、子宮、精巣、脳下垂体、生殖器官、肝臓、胆嚢、眼、耳、鼻、咽頭、扁桃、口、及びリンパ節並びにリンパ系からなる群から選ばれる組織のウィルス性、細菌性、又は寄生虫性変化である、請求項5に記載の医薬組成物。
- 前記状態が、肺、乳房、胃、膵臓、前立腺、膀胱、骨、卵巣、皮膚、腎臓、洞、結腸、腸、胃、直腸、食道、心臓、脾臓、唾液腺、血液、脳及びその外皮、脊髄及びその外皮、筋肉、結合組織、副腎、副甲状腺、甲状腺、子宮、精巣、脳下垂体、生殖器官、肝臓、胆嚢、眼、耳、鼻、咽頭、扁桃、口、及びリンパ節並びにリンパ系からなる群から選ばれる組織の奇形である、請求項5に記載の医薬組成物。
- 前記組織がリンパ組織である、請求項8ないし11のいずれか1項に記載の医薬組成物。
- 前記状態が扁桃肥大である、請求項5に記載の医薬組成物。
- 前記状態が前立腺過形成である、請求項5に記載の医薬組成物。
- 前記状態が乾癬である、請求項5に記載の医薬組成物。
- 前記状態が湿疹である、請求項5に記載の医薬組成物。
- 前記状態が皮膚病である、請求項5に記載の医薬組成物。
- 前記状態が組織に対する美容修正である、請求項5に記載の医薬組成物。
- 前記組織が、皮膚、眼、耳、鼻、咽頭、口、筋肉、結合組織、毛髪、及び乳房である、請求項8に記載の医薬組成物。
- 前記状態が血管疾患である、請求項5に記載の医薬組成物。
- 前記状態が痔である、請求項5に記載の医薬組成物。
- 前記状態が静脈瘤である、請求項5に記載の医薬組成物。
- 前記血管疾患がアテローム性動脈硬化又は動脈硬化である、請求項20に記載の医薬組成物。
- 前記状態が、炎症性疾患、自己免疫疾患、代謝性疾患、遺伝性疾患/遺伝病、外傷性疾患又は身体外傷、栄養欠乏症、感染症、アミロイド病、線維症、沈着症、先天性奇形、酵素欠乏症、中毒、酩酊、環境病、放射線疾患、内分泌性疾患、消耗性疾患及び機械的疾患からなる群から選ばれる、請求項5に記載の医薬組成物。
- 前記状態が、動脈の又は動脈内に設置又は移植されたステントの狭窄、再狭窄、閉塞又は遮断である、請求項5に記載の医薬組成物。
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