JP2021155448A - ワクチンを使用して癌または皮膚病変を治療するための方法および組成物 - Google Patents
ワクチンを使用して癌または皮膚病変を治療するための方法および組成物 Download PDFInfo
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Abstract
Description
市販品として入手できる予防ワクチンを含むHPV L1タンパク質などの、より多くのウイルス特異的成分を必要とする。
Rev Oral Biol Med.2003;14(5):345−62に記載されている。宿主細胞タンパク質(BAX)を含む別のワクチンは、米国特許第8,399,610号明細書に記載されている。
a)宿主細胞ペプチド、ポリペプチド、もしくはタンパク質、またはこれらの分解産物を含まない第1の用量のHPVワクチンを、27歳以上の患者、またはHPVワクチンで以前に免疫されていない患者に投与するステップと;
b)第1の投与の約1か月から約3か月後に、第2の用量のHPVワクチンを、患者に投与するステップと;
c)任意で、第1の用量の約5か月から約7か月後に、第3の用量のHPVワクチンを、患者に投与するステップと
を含む。
第1の用量を投与した約1か月から約3か月後に、第2の用量のHPVワクチンを、腫瘍もしくは病変に、または腫瘍もしくは病変を直接取り囲む範囲に、直接的に投与するステップと;
第1の用量を投与した約5か月から約7か月後に、第3の用量のHPVワクチンを、腫瘍もしくは病変に、または腫瘍もしくは病変を直接取り囲む範囲に、直接的に、任意で投与するステップ
をさらに含むことができる。
とができる。
含むこともできるし、1種以上の賦形剤または希釈剤と、1種以上の活性な医薬成分を含むこともできる。
i.宿主細胞ペプチド、ポリペプチド、またはタンパク質を含まない第1の用量のHPV組換えワクチンを、患者に投与するステップ;
ii.第1の用量の約1か月から約3か月後に、宿主細胞ペプチド、ポリペプチド、またはタンパク質を含まない第2の用量のHPV組換えワクチンを、患者に投与するステップ;および
iii.任意で第1の用量を投与した約5か月から約7か月後に、宿主細胞ペプチド、ポリペプチド、またはタンパク質を含まない第3の用量のHPVワクチンを、患者に投与するステップ
を含む前記方法を含む。
あってもよいし、病変に対する直接的投与によるものであってもよい。病変に対するワクチン組成物の直接的投与は、病巣内注射によるものであってもよいし、病変に対して局所的に適用されてもよい。さらなる実施態様では、第2、第3、または後続投与は、全身的であるものと、病変に対するワクチンの直接的適用によるものとの両方である。病変に対するこうした直接的投与は、局所投与のために製剤化されたワクチン組成物の、病巣内注射によるまたは局所適用によるものであり得る。
、ホジキンリンパ腫、非ホジキンリンパ腫、急性骨髄性白血病(AML)、多発性骨髄腫、胃腸癌、腎癌、卵巣癌、肝癌、リンパ芽球性白血病、リンパ球性白血病、結腸直腸癌、子宮内膜癌、腎癌、前立腺癌、甲状腺癌、メラノーマ、軟骨肉腫、神経芽腫、膵癌、多形神経膠芽腫、子宮頸癌、脳癌、胃癌、膀胱癌、ヘパトーマ、乳癌、結腸癌、および頭頸部癌が挙げられる。ある種の例示的実施態様では、癌は、HPVと関係がある癌である。
ド、ポリペプチド、またはタンパク質を実質的に含まない)の1回以上の注射の投与後に、皮膚癌、および特に扁平上皮癌の再発率を低下させる方法を提供することが、本発明のさらなる予想外の結果である。
対象となる治療方法のさらなる予想外の結果は、基底細胞癌またはメラノーマなどの、HPV感染と関係がない皮膚病変の、サイズを低下させること、消失させること、または再発率を低下させることを含む。
適切な溶媒中に、必要とされる量の活性な化合物を組み込み、それに続いて濾過滅菌を行うことによって調製することができる。一般に、分散系は、基本分散媒および上に列挙したものからの必要とされる他の成分を含有する無菌ビヒクルに、活性な化合物を組み込むことによって調製される。無菌注射液の調製のための無菌粉末の場合には、調製の好ましい方法は、あらかじめ滅菌濾過したその溶液から、活性成分+いずれかの追加の所望の成分の粉末をもたらす、真空乾燥および凍結乾燥である。
1)ビタミンDおよびその類似体;
2)シロリムス;
3)インターフェロンおよびその類似体;
4)ビタミンAおよびその類似体、例えばSoriatane(レチノイド)
5)イミキモド;
6)インゲノールメブテート;および
7)T4エンドヌクレアーゼ
8)代謝拮抗剤、例えば5フルオロウラシル、メトトレキサート
9)シクロオキシゲナーゼ阻害剤、例えばジクロフェナク
シンおよびアンサマイトシン;ミトグアゾン;ミトキサントロン;モピダモール;ニトラクリン;ペントスタチン;フェナメット;ピラルビシン;ロソキサントロン;ポドフィリン酸;2−エチルヒドラジド;プロカルバジン;ラゾキサン;リゾキシン;シゾフラン(sizofuran);スピロゲルマニウム;テヌアゾン酸;トリアジコン;2,2’,2’’−トリクロロトリエチルアミン;トリコテシン(特にT−2トキシン、ベラキュリン(verracurin)A、ロリジンA、およびアングイジン);ウレタン;ビンデシン;ダカルバジン;マンノムスチン;ミトブロニトール;ミトラクトール;ピポブロマン;ガシトシン(gacytosine);アラビノシド(「Ara−C」);シクロホスファミド;チオテパ;タキソイド、例えばパクリタキセルおよびドキセタキセル(doxetaxel);クロラムブシル;ゲムシタビン;6−チオグアニン;メルカプトプリン;メトトレキサート;白金類似体、例えば、シスプラチンおよびカルボプラチン;ビンブラスチン;白金;エトポシド(VP−16);イホスファミド;ミトキサントロン;ビンクリスチン;ビノレルビン;ノバントロン;テニポシド;エダトレキサート;ダウノマイシン;アミノプテリン;ゼローダ;イバンドロネート;CPT−11;トポイソメラーゼ阻害剤RFS 2000;ジフルオロメチルオルニチン(DMFO);レチノイド、例えば、レチノイン酸;カペシタビン;および上述のもののいずれかの薬学的に許容し得る塩、酸、または誘導体が挙げられる。また、腫瘍に対するホルモン作用を調節または阻害するように作用するホルモン拮抗剤(anti−hormonal agent)、例えば、抗エストロゲン薬および選択的エストロゲン受容体調節薬(SERM)(例えば、タモキシフェン、ラロキシフェン、ドロロキシフェン、4−ヒドロキシタモキシフェン、トリオキシフェン、ケオキシフェン、LY117018、オナプリストン、およびトレミフェン(フェアストン)が含まれる);副腎におけるエストロゲン産生を調節する酵素アロマターゼを阻害するアロマターゼ阻害剤(例えば、4(5)−イミダゾール、アミノグルテチミド、酢酸メゲストロール、エキセメスタン、ホルメスタン、ファドロゾール、ボロゾール、レトロゾール、およびアナストロゾールなど);ならびに抗アンドロゲン薬、例えば、フルタミド、ニルタミド、ビカルタミド、ロイプロリド、およびゴセレリン;ならびに上述のもののいずれかの薬学的に許容し得る塩、酸、または誘導体も挙げられる。
i.第1の用量の約1か月から約3か月後に、第2の用量のHPVワクチンを、患者の癌病変、良性腫瘍、または非癌性のHPV関連の病変に直接的に投与するステップ;
ii.第1の用量を投与した約5か月から約7か月後に、後続の用量のHPVワクチンを
、患者の癌病変、良性腫瘍、または非癌性のHPV関連の病変に直接的に投与するステップ;または
iii.第1の用量の約1か月から約3か月後に、第2の用量のHPVワクチンを、患者の癌病変、良性腫瘍、または非癌性のHPV関連の病変に直接的に投与し、かつ第1の用量を投与した約5か月から約7か月後に、後続の用量のHPVワクチンを、患者の癌病変、良性腫瘍、または非癌性のHPV関連の病変に直接的に投与するステップ。
は、一般に、少なくとも0.05μg/kg、0.2μg/kg、0.5μg/kg、1μg/kg、10μg/kg、100μg/kg、0.2mg/kg、1.0mg/kg、2.0mg/kg、10mg/kg、25mg/kg、50mg/kg(体重)、またはそれ以上である。例えば、Yang et al.(2003)New Engl.J.Med.349:427−434;Herold et al.(2002)New Engl.J.Med.346:1692−1698;Liu et al.(1999)J.Neurol.Neurosurg.Psych.67:451−456;Portielji et al.(20003)Cancer Immunol.Immunother.52:133−144を参照のこと。
、5、5と1/2、6、6と1/2、7、7と1/2、8、8と1/2、9、9と1/2、10、10と1/2、11、11と1/2、12、12と1/2、13、13と1/2、14、14と1/2週、またはそれ以上)後に投与される。別の例示的実施態様では、各第2のおよび/または第3の用量は、直前の用量の、1から14か月(例えば、1、1と1/2、2、2と1/2、3、3と1/2、4、4と1/2、5、5と1/2、6、6と1/2、7、7と1/2、8、8と1/2、9、9と1/2、10、10と1/2、11、11と1/2、12、12と1/2、13、13と1/2、14、14と1/2か月、またはそれ以上)後に投与される。語句「直前の用量」は、本明細書で使用する場合、一連の反復投与における、その間の用量を伴わない順序で、まさにその次の用量の前に患者に投与されるHPVワクチンの用量を意味する。
び18型)組換えワクチンまたはHPV多価(16、18、31、33、45、52、および58型)組換えワクチンの1回以上の注射の直接的または局所的投与後に、皮膚癌、および特に扁平上皮癌を消失させるまたはサイズを低下させる方法を提供することが、本発明のさらなる予想外の結果である。
1)ビタミンDおよびその類似体;
2)シロリムス;
3)インターフェロンおよびその類似体;
4)ビタミンAおよびその類似体、例えばSoriatane(レチノイド)
5)イミキモド;
6)インゲノールメブテート;および
7)T4エンドヌクレアーゼ
8)代謝拮抗剤、例えば5フルオロウラシル、メトトレキサート
9)シクロオキシゲナーゼ阻害剤、例えばジクロフェナク
用量のHPV四価(6、11、16、および18型)組換えワクチン、および第2の用量のおよそ4か月後の第3の用量のHPV四価(6、11、16、および18型)組換えワクチンの投与を含む。好ましい実施態様では、各用量は、0.5mlである。
1)ビタミンDおよびその類似体;
2)シロリムス;
3)インターフェロンおよびその類似体;
4)ビタミンAおよびその類似体、例えばSoriatane(レチノイド)
5)イミキモド;
6)インゲノールメブテート;および
7)T4エンドヌクレアーゼ
8)代謝拮抗剤、例えば5フルオロウラシル、メトトレキサート
9)シクロオキシゲナーゼ阻害剤、例えばジクロフェナク
ともできる。
次の表は、扁平上皮癌(SCC)および基底細胞癌を含めた皮膚癌の、比較的に高頻度の再発率を経験している3群の患者において実施された治療の対象方法による結果を提供する。
患者1に、第1の0.5ml用量、2か月後の第2の0.5ml用量、および第2の用量の4か月後の第3の0.5ml用量を含めた、3回の0.5ml用量を投与した。HPV四価(6、11、16、および18型)組換えワクチンの第3の用量の投与の3か月後のフォローアップ検査では、患者1は、3か月の期間の間、SCC型とBCC型との両方を含めた皮膚癌の再発がなかった。治療方法の開始前に、患者1は、生存期間中に皮膚癌の300を超える特徴的な発生が起こった。
患者2に、第1の0.5ml用量、2か月後の第2の0.5ml用量、および第2の用量の4か月後の第3の0.5ml用量を含めた、3回の0.5ml用量のHPV四価(6、11、16、および18型)組換えワクチンを投与した。
患者3に、第1の0.5ml用量、2か月後の第2の0.5ml用量、および第2の用量の8か月後の第3の0.5ml用量を含めた、3回の0.5ml用量のHPV四価(6、11、16、および18型)組換えワクチンを投与した。
以前にHPVワクチン接種を受けた32歳の女性(乳癌歴なし、家族歴なし、危険因子なし)が、転移性乳癌と診断された。彼女の主腫瘍は、超音波によって、直径約4.1セ
ンチメートルであると測定された。これらの転移性腫瘍は、約12週で、サイズが2倍になる可能性がある。
99歳の女性が、下肢に転移性基底扁平細胞癌を呈した。転移性基底扁平細胞癌は、彼女が緩和療法のために皮膚科に紹介されるほど重症であり、癌のさらなる拡散を予防するための肢の切断以外のさらなる選択肢は利用可能ではなかった。
45歳のHIV陽性の男性(様々な局所的および外科的方法での治療に対して不応性であった陰茎の扁平上皮癌の2年の病歴あり)を、ラベルの指示に従って、筋肉内への3回の等用量のGARDASIL(登録商標)で治療した。
高齢男性(腎細胞癌の病歴、および化学療法歴あり)の下肢上の侵襲性の急速増殖性の再発性扁平上皮癌を、エピネフリンを含むリドカイン1%と混合したGARDASIL(登録商標)の2回の病巣内注射で治療した。
前立腺癌治療は、患者を筋肉内HPVで治療することを含むであろう。また、前立腺への直接的注射も含むことができる。
多形神経膠芽腫治療は、患者を筋肉内HPV、次いで多形神経膠芽腫の腫瘍への直接的注射で治療することを含むであろう。
子宮頸癌治療は、患者を筋肉内HPVで治療することを含むであろう。また、子宮頚部への直接的注射も含むことができる。
肛門癌治療は、患者を筋肉内HPVで治療することを含むであろう。また、肛門に対する直接的注射または局所適用も含むことができる。
Claims (13)
- 少なくとも1種の精製されたウイルスL1タンパク質またはその断片、
第2の活性な医薬成分および
薬学的に許容し得る担体を含む医薬組成物。 - 前記第2の活性な医薬成分が、局所麻酔剤である請求項1に記載の医薬組成物。
- 前記局所麻酔剤が、プロカイン、ベンゾカイン、クロロプロカイン、コカイン、シクロメチカイン、ジメトカイン/ラロカイン、ピペロカイン、プロポキシカイン、プロカイン、プロパラカインおよびテトラカイン、リドカイン、アルチカイン、ブピバカイン、シンコカイン、エチドカイン、レボブピバカイン、リグノカイン、メピバカイン、プリロカイン、ロピバカイン並びにトリメカインからなる群から選択される請求項2に記載の医薬組成物。
- 前記局所麻酔剤が、リドカインである請求項2に記載の医薬組成物。
- 前記第2の活性な医薬成分が、ビタミンD、ビタミンD類似体、ビタミンA、ビタミンA類似体、シロリムス、インターフェロン、インターフェロン類似体、イミキモド、インゲノールメブテート、T4エンドヌクレアーゼ、代謝拮抗剤およびシクロオキシゲナーゼ阻害剤からなる群から選択される免疫調節剤である請求項1に記載の医薬組成物。
- 前記代謝拮抗剤が、5−フルオロウラシルまたはメトトレキサートである請求項5に記載の医薬組成物。
- 前記シクロオキシゲナーゼ阻害剤が、ジクロフェナクである請求項5に記載の医薬組成物。
- 注射用形態である請求項1から7のいずれか1項に記載の医薬組成物。
- 局所用形態である請求項1から7のいずれか1項に記載の医薬組成物。
- 前記少なくとも1種の精製されたウイルスL1タンパク質またはその断片が、ヒトパピローマウイルス(HPV)L1タンパク質またはその断片である請求項1から9のいずれか1項に記載の医薬組成物。
- HPV6、11、16および18型のそれぞれから得られる精製されたウイルスL1タンパク質またはその断片を含む請求項10記載の医薬組成物。
- HPV16、18、31、33、45、52および58型のそれぞれから得られる精製されたウイルスL1タンパク質またはその断片を含む請求項10に記載の医薬組成物。
- 前記少なくとも1種の精製されたウイルスL1タンパク質またはその断片が、ウイルス様粒子(VLP)内に存在する請求項1から12のいずれか1項に記載の医薬組成物。
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JP2015514696A (ja) * | 2012-03-18 | 2015-05-21 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | ヒト・パピローマウイルスに対するワクチン接種方法 |
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EP2419143B8 (en) * | 2009-04-13 | 2018-06-27 | INSERM - Institut National de la Santé et de la Recherche Médicale | Hpv particles and uses thereof |
CN101890160B (zh) * | 2009-04-28 | 2014-06-18 | 北京康乐卫士生物技术有限公司 | 多价重组人乳头瘤病毒疫苗及其应用 |
CN102497880A (zh) * | 2009-06-25 | 2012-06-13 | 葛兰素史密丝克莱恩生物有限公司 | 新的人乳头状瘤病毒(hpv)蛋白构建体及其在预防hpv疾病中的用途 |
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JP2023110038A (ja) | 2023-08-08 |
BR112018067550A2 (pt) | 2019-10-01 |
MY194694A (en) | 2022-12-15 |
CO2018009205A2 (es) | 2018-09-20 |
AU2017223970B2 (en) | 2022-01-27 |
IL261340A (en) | 2018-11-29 |
EP3419661A4 (en) | 2019-10-23 |
CA3015519A1 (en) | 2017-08-31 |
SG11201807080UA (en) | 2018-09-27 |
IL261340B2 (en) | 2023-07-01 |
CN108883168A (zh) | 2018-11-23 |
JP2019506435A (ja) | 2019-03-07 |
CL2018002438A1 (es) | 2019-01-04 |
KR20180112043A (ko) | 2018-10-11 |
ZA201805679B (en) | 2019-11-27 |
MX2018010338A (es) | 2018-11-09 |
WO2017147475A1 (en) | 2017-08-31 |
EP3419661A1 (en) | 2019-01-02 |
HK1256935A1 (zh) | 2019-10-04 |
IL261340B1 (en) | 2023-03-01 |
AU2017223970A1 (en) | 2018-09-13 |
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