JP2015532286A - 感染症治療用グリコシダーゼレジメン - Google Patents
感染症治療用グリコシダーゼレジメン Download PDFInfo
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- JP2015532286A JP2015532286A JP2015534663A JP2015534663A JP2015532286A JP 2015532286 A JP2015532286 A JP 2015532286A JP 2015534663 A JP2015534663 A JP 2015534663A JP 2015534663 A JP2015534663 A JP 2015534663A JP 2015532286 A JP2015532286 A JP 2015532286A
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Abstract
Description
本願は、2012年9月28日に出願された米国特許仮出願第61/707,252号の優先権を主張し、その全文を参照することにより、本明細書中に組み入れられるものとする。
本発明は、疾病の治療および予防に関し、具体的には、グリコシダーゼ療法を行っている慢性および非慢性ウイルス性感染症および他の感染症を含む、感染症の予防、治療および管理に関する。
モデルウイルスとしてHSV−1を使用して、生体外試験を、ベロ細胞からのウイルスの感染力および放出に対する、ノイラミニダーゼおよび補体の影響を測定するために開始する。感染力の試験のため、補体、ウイルスおよびノイラミニダーゼの組み合わせを、一緒にインキュベートし、それから、ベロ細胞に添加して、さらにインキュベートした。細胞固定および染色に続き、該細胞中のウイルス形成プラークをカウントした。結果は、該ウイルスを、ノイラミニダーゼおよび補体と一緒にインキュベートすると、対照と比較して、ベロ細胞の該ウイルス感染力が、有意に(70〜80%)減少することを示した(図1)。
生体外での特定のサイトカイン産生に対するノイラミニダーゼの効果を、調査した。サイトカインは、感染症に応答する活性化リンパ球により分泌された化学的メッセンジャーである。いずれの所与のサイトカインも、単独あるいは他のサイトカインとの組み合わせで、免疫機能に対して多くの効果を有し得る。インターロイキン−2(IL−2)、インターフェロンα(IFN−α)、インターフェロンγ(IFN−γ)および腫瘍壊死因子α(TNF−α)は、ウイルスからの宿主防御に関係する重要なサイトカインである。IL−2、TNF−αおよびIFN−γは、T細胞のヘルパーT(TH1)サブセットにより産生され、従って、炎症過程に関連する。IL−2およびIFN−γは、一緒に、病原体を貪食および消化する(食作用)重要な免疫細胞であり、Tリンパ球に対する抗原提示細胞としても働くマクロファージを活性化する。。IL−2およびIFN−γは、ウイルス性感染細胞を取り除くとき、ナチュラルキラー(NK)細胞の細胞障害性も増強する。IFN−γは、抗原提示細胞上の主要組織適合性複合体(MHC)クラスIおよびII分子の発現も増強し、それにより、ウイルス排除に関係するCD4+およびCD8+細胞溶解性細胞を誘発する。IFN−γは、TNF−αと相まって、NK細胞を刺激する。IFN−αは、ウイルスの初期タンパク質の転写の遮断により、ウイルスの複製を阻害する。
Claims (48)
- 慢性ウイルス性感染症を有する患者を治療する方法であって、
前記感染症を治療、寛解、および/または管理するため、前記患者に、免疫寛容および免疫シグナリンググリコシダーゼ組成物の非急性レジメンを投与すること
を含む方法。 - 前記患者が、HIV陽性である、請求項1記載の方法。
- 前記患者が、エイズを有する、請求項2記載の方法。
- 前記患者が、抗ウイルス化学治療を受けていない、および/または前記HIVが、抗ウイルス治療に耐性がある、請求項1〜3のいずれか1項に記載の方法。
- 前記レジメンが、抗ウイルス治療後に開始され、慢性エイズを管理する、請求項3記載の方法。
- 前記組成物が、病状経過を逆転する抗ウイルス治療と一緒に投与され、および少なくとも6ヶ月間、または少なくとも1年間、または少なくとも2年間、または少なくとも5年間続けてもよく、任意にARV療法することなく、前記感染症を管理する、請求項3記載の方法。
- 前記レジメンの開始時の患者のCD4カウントが、500未満である、請求項1〜6のいずれか1項に記載の方法。
- 前記レジメンの開始時の患者のCD4カウントが、200と400の間である、請求項7記載の方法。
- 前記レジメンの開始時の患者のCD4カウントが、400未満、350未満、300未満、200未満、100未満、または50未満である、請求項7記載の方法。
- 前記レジメンの開始時のウイルス量が、10,000/mlより大である、請求項2〜9のいずれか1項に記載の方法。
- 前記レジメンの開始時のウイルス量が、少なくとも25,000/ml、少なくとも40,000/ml、少なくとも50,000/ml、少なくとも75,000/ml、少なくとも100,000/ml、少なくとも500,000/ml、少なくとも1,000,000/ml、または少なくとも5,000,000/mlである、請求項10記載の方法。
- 前記患者が、単純ヘルペスウイルス感染症、水痘帯状疱疹ウイルス感染症、A型、B型、またはC型肝炎、アデノウイルス感染症、またはヒトパピローマウイルス感染症から選択される慢性ウイルス性感染症を有する、請求項1記載の方法。
- 前記患者が、帯状疱疹を有する、請求項12記載の方法。
- 前記グリコシダーゼレジメンが、ノイラミニダーゼの投与を含む、請求項1〜13のいずれか1項に記載の方法。
- ガラクトシダーゼ、N−アセチルガラクトシダーゼ、フコシダーゼ、グルコシダーゼ、N−アセチルグルコサミニダーゼ、およびマンノシダーゼの内1つ以上の投与をさらに含む、請求項14記載の方法。
- 持続性または再発性細菌感染症を有する患者にグリコシダーゼのレジメンを投与することを含む、前記患者を治療する方法。
- 前記細菌感染症が、肺炎、気管支炎、副鼻腔炎、腸炎、大腸炎、敗血症、または尿路感染症に関連している、請求項16記載の方法。
- 前記細菌感染症が、持続性または再発性の、耳、眼、鼻および/または咽喉感染症である、請求項16記載の方法。
- 前記細菌が、マイコバクテリウム属、シュードモナス属、ヘモフィルス属、モラクセラ属、クラミジア属、ナイセリア属、ストレプトコッカス属、スタフィロコッカス属、ボルデテラ属、またはエルシニア属の一種である、請求項16〜18のいずれか1項に記載の方法。
- 前記細菌が、Mycobacterium tuberculosisである、請求項19記載の方法。
- 抗生物質治療の少なくとも1回診目が、前記感染症を寛解または除去できなかった後に、前記グリコシダーゼレジメンが投与される、請求項16〜20のいずれか1項に記載の方法。
- 抗生物質治療と並行して、前記グリコシダーゼレジメンが投与される、請求項14〜18のいずれか1項に記載の方法。
- 前記抗生物質治療が、1つ以上の、アミノグリコシド系抗生物質、カルバペネム系抗生物質(carbapenum)、セファロスポリン系抗生物質、マクロライド系抗生物質、βラクタム系抗生物質、キノロン系抗菌薬、サルファ薬、またはテトラサイクリン系抗生物質を用いる、請求項20記載の方法。
- 前記グリコシダーゼレジメンが、ノイラミニダーゼの投与を含む、請求項16〜23のいずれか1項に記載の方法。
- ガラクトシダーゼ、N−アセチルガラクトシダーゼ、フコシダーゼ、グルコシダーゼ、N−アセチルグルコサミニダーゼ、およびマンノシダーゼの内1つ以上の投与をさらに含む、請求項24記載の方法。
- グリコシダーゼレジメンを、それを必要とする患者に投与することを含む、真菌または寄生虫感染症を治療する方法。
- 前記感染症が、カンジダ症である、請求項26記載の方法。
- 前記感染症が、マラリアまたはトリパノソーマ症である、請求項26記載の方法。
- 前記グリコシダーゼレジメンが、ノイラミニダーゼの投与を含む、請求項26〜28のいずれか1項に記載の方法。
- ガラクトシダーゼ、N−アセチルガラクトシダーゼ、フコシダーゼ、グルコシダーゼ、N−アセチルグルコサミニダーゼ、およびマンノシダーゼの内1つ以上の投与をさらに含む、請求項29記載の方法。
- 免疫シグナリンググリコシダーゼのレジメンを、前記患者に投与することを含み、前記レジメンが、ワクチン接種前、ワクチン接種中、またはワクチン接種後に始まる、ワクチン接種を増強する方法。
- 前記ワクチンが、アジュバントを含まないワクチンである、請求項31記載の方法。
- 前記グリコシダーゼが、舌下、鼻腔内、ポート、真皮下、経管、眼内、静脈内、筋肉内、皮下、経皮、および口腔から選択される経路により投与される、請求項1〜32のいずれか1項に記載の方法。
- 前記グリコシダーゼが、舌下に投与される、請求項33記載の方法。
- 前記グリコシダーゼレジメンが、ノイラミニダーゼの投与を含む、請求項31〜34のいずれか1項に記載の方法。
- ガラクトシダーゼ、N−アセチルガラクトシダーゼ、フコシダーゼ、グルコシダーゼ、N−アセチルグルコサミニダーゼ、およびマンノシダーゼの内1つ以上の投与をさらに含む、請求項35記載の方法。
- 前記グリコシダーゼが、免疫調節活性を維持する、生体起源のグリコシダーゼ、またはその誘導体もしくはその活性部分である、請求項1〜36のいずれか1項に記載の方法。
- 前記グリコシダーゼが、生物学的原料または合成品である、請求項35または36記載の方法。
- 前記グリコシダーゼが、少なくとも1ヶ月間、1日に平均2〜6回投与される、請求項1〜38のいずれか1項に記載の方法。
- 前記グリコシダーゼが、少なくとも2ヶ月間、少なくとも4ヶ月間、または少なくとも6ヶ月間、1日に平均2〜6回投与される、請求項39記載の方法。
- 前記患者が、少なくとも6ヶ月間、または少なくとも1年間、または少なくとも2年間、または少なくとも5年間、またはそれ以上、1日に約1回の用量で、慢性的に、続けて治療される、請求項39記載の方法。
- グリコシダーゼ組成物の投与用途の薬剤アプリケータであって、前記アプリケータが、ノイラミニダーゼ組成物の少なくとも100用量を含む薬剤アプリケータ。
- 前記アプリケータが、舌下、経鼻、経皮、持続放出性真皮下、眼内、経管、ポート、皮下、経口または口腔送達用である、請求項42記載の薬剤アプリケータ。
- 前記アプリケータが、舌下送達用である、請求項42記載の薬剤アプリケータ。
- 前記アプリケータが、残りの用量の無菌条件を維持する方法で用量を分配する、請求項42〜44のいずれか1項に記載の薬剤アプリケータ。
- 前記アプリケータが、50〜100μlの用量を送達する、請求項45記載の薬剤アプリケータ。
- 前記グリコシダーゼがノイラミニダーゼを含む、請求項42〜46のいずれか1項に記載の薬剤アプリケータ。
- 前記グリコシダーゼが、ノイラミニダーゼ、ガラクトシダーゼ、N−アセチルガラクトシダーゼ、フコシダーゼ、グルコシダーゼ、N−アセチルグルコサミニダーゼ、およびマンノシダーゼの少なくとも2つを含む、請求項42〜46のいずれか1項に記載の薬剤アプリケータ。
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US201261707252P | 2012-09-28 | 2012-09-28 | |
US61/707,252 | 2012-09-28 | ||
PCT/US2013/061966 WO2014052621A1 (en) | 2012-09-28 | 2013-09-26 | Glycosidase regimen for treatment of infectious disease |
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CN106102776B (zh) | 2014-01-24 | 2020-02-14 | 圣安德鲁斯大学董事会 | 免疫调节化合物 |
GB201616007D0 (en) | 2016-09-20 | 2016-11-02 | Univ Court Of The Univ Of St Andrews The | Novel Adjuvants |
GB201616009D0 (en) | 2016-09-20 | 2016-11-02 | Univ Court Of The Univ Of St Andrews The | Treatment and/or prevention of sepsis |
GB201616006D0 (en) | 2016-09-20 | 2016-11-02 | Univ Court Of The Univ Of St Andrews The | Cell modulation |
US10889961B2 (en) * | 2017-08-08 | 2021-01-12 | Entro Industries, Inc. | Automatic walking for a load transporting apparatus |
US20230277634A1 (en) * | 2020-08-17 | 2023-09-07 | The Regents Of The University Of California | Application of microbial glycosidase as an anti-viral therapeutic, prognostic, and diagnostic |
CN113663053A (zh) * | 2021-08-20 | 2021-11-19 | 广西壮族自治区兽医研究所 | Ifi6蛋白或调控ifi6蛋白基因表达的物质在制备禽呼肠孤病毒抑制剂中的应用 |
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CN104902926A (zh) | 2015-09-09 |
AU2018203958A1 (en) | 2018-06-21 |
AU2013323472B2 (en) | 2018-07-05 |
DK2900259T3 (da) | 2020-07-13 |
CA2886474A1 (en) | 2014-04-03 |
AU2013323472A1 (en) | 2015-04-16 |
MX2015004009A (es) | 2015-12-09 |
EP2900259A4 (en) | 2016-07-13 |
ES2805795T3 (es) | 2021-02-15 |
JP6673696B2 (ja) | 2020-03-25 |
EP2900259B1 (en) | 2020-04-15 |
US20190091305A1 (en) | 2019-03-28 |
KR20210019605A (ko) | 2021-02-22 |
KR20150063079A (ko) | 2015-06-08 |
EP2900259A1 (en) | 2015-08-05 |
MX2020011107A (es) | 2020-11-11 |
AU2018203958B2 (en) | 2020-02-20 |
CN112755178A (zh) | 2021-05-07 |
US20150238580A1 (en) | 2015-08-27 |
WO2014052621A1 (en) | 2014-04-03 |
US10675336B2 (en) | 2020-06-09 |
US20200261557A1 (en) | 2020-08-20 |
EP3741387A1 (en) | 2020-11-25 |
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