JP2013527846A - 口腔粘膜を介してアレルギーを減感作するための方法、物品及びキット - Google Patents
口腔粘膜を介してアレルギーを減感作するための方法、物品及びキット Download PDFInfo
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Abstract
【選択図】なし
Description
本発明は、口腔粘膜領域、例えば樹状細胞の肥満細胞に対する比率が高い口腔粘膜領域を標的とした、特に前庭粘膜を標的とした、アレルギーに対する免疫療法に関する。いくつかの側面で本発明は、例えば、舌下免疫療法の際の安全性プロファイルが高く、接触時間や効果が高い送達物品と剤形に関する。
いくつかの態様では、アレルゲンは、組換え的に生成されたタンパク質を含む。組換えDNA技術によってタンパク質を生成する方法は当該分野で良く知られており、かつ、Ausubel, F., et al., (eds.), Current Protocols in Molecular Biology(分子生物学の実務), Current Protocols in Immunology(免疫学の実務), Current Protocols in Protein Science(タンパク質科学の実務), and Current Protocols in Cell Biology(細胞生物学の実務), all John Wiley & Sons, N.Y., editions as of 2008; Sambrook, Russell, and Sambrook, Molecular Cloning: A Laboratory Manual(分子のクローニング:研究の手引き), 3rd ed., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, 2001; Harlow, E. and Lane, D., Antibodies - A Laboratory Manual(研究の手引き), Cold Spring Harbor Laboratory Press, Cold Spring Harbor, 1988; Burns, R., Immunochemical Protocols (Methods in Molecular Biology) (免疫科学の手順(分子生物学の技術)) Humana Press; 3rd ed., 2005のような標準的な参考文献に記載されており、これら全ては参照により本明細書に組み込まれる。様々な態様では、アレルゲンタンパク質をコードしている核酸を宿主細胞に導入するために、いかなる好適なベクター、例えばプラスミド、ウイルス(例えば、DNA又はRNAウイルス)、コスミドなどをも利用することができる。遺伝暗号には縮重があるため、多様な核酸配列のいずれもが目的のタンパク質(例えばアレルゲン)をコードすることができ、かつ、アレルゲンの組換え生産に関する本発明の様々な態様において使用できることを、当業者は分かっている。いくつかの態様では、目的の宿主細胞でタンパク質を生産させるために、核酸配列のコドンを最適化する。いかなる好適な発現系を使用することができる。様々な宿主細胞、例えば細菌、真菌、昆虫、脊椎動物(例えば哺乳類)の細胞を、様々な態様で使用することができる。いくつかの態様では、宿主細胞を、少なくともアレルゲンの一部に基づいて選択する。例えば、いくつかの態様では、植物アレルゲンを植物細胞中で生産させることができ、脊椎動物アレルゲンを脊椎動物細胞中で生産させることができ、真菌アレルゲンを真菌細胞中で生産させることができる。アレルゲンを、遺伝子組換えを用いた方法、例えば遺伝子組換え植物によって生産することもできる。いくつかの態様では、組換え的に生産したアレルゲンの配列は、天然に生じるアレルゲンタンパク質の配列の断片や変異体を含む。例えば断片は、天然に生じるアレルゲンタンパク質の少なくとも20%、30%、40%、50%、60%、70%、80%、90%、又は完全長以上を含む、連続した配列であってよい。変異体は、天然に生じるアレルゲンタンパク質と比較して、1以上のアミノ酸置換、欠損、又は付加(例えば挿入)を有する。例えば変異体は、天然に生じるアレルゲンタンパク質と少なくとも70%、80%、90%、95%、96%、97%、98%、99%、又はそれ以上同一の配列を含む場合があり、これは天然に生じる抗原の観点では少なくとも50%、60%、70%、80%、90%、95%、96%、97%、98%、99%、又はそれ以上が同一であり、そのため、同一性を最大にするためにギャップを挿入することができる。同一性の百分率は、当該分野で知られている様々なコンピュータープログラムにより計算することができる。例えば、BLAST2、BLASTN、BLASTP、Gapped BLASTなどのようなコンピュータープログラムは、目的の配列と様々な公開されているデータベースのいずれかに含まれる配列間での整列を生成し、同一性の百分率を提供する。Altschulら(Altschul, et al., J. Mol. Biol. 215:403-410, 1990)のNBLAST 及びXBLASTプログラムには、Karlin and Altschul(Proc. Natl. Acad. Sci. USA 90:5873-5877,1993)で修正された、Karlin and Altschul, Proc. Natl. Acad. Sci. USA 87:22264-2268, 1990)のアルゴリズムが組み込まれている。比較目的でギャップの挿入された整列を得るためには、Altschulら(Altschul, et al. Nucleic Acids Res. 25: 3389-3402, 1997)に記載されたGapped BLASTを利用する。BLAST及びGapped BLASTプログラムを利用する場合には、それぞれのプログラムで予め設定されている指標を使用する。PAM250又はBLOSUM62マトリックスを使用してもよい。これらのプログラムについては、URLがwww.ncbi.nlm.nih.govのウェブサイトを参照のこと。特定の態様では、BLAST2を利用して、予め設定されている指標により、同一性の百分率を計算する。いくつかの態様では、変異体は、約1%、5%、10%、20%、又は30%までのアミノ酸置換、挿入又は欠損を有する。いくつかの態様では、変異体は、1〜10までのアミノ酸置換、挿入又は欠損を有する。
いくつかの態様では、本発明の医薬組成物(例えば、パウチに封入するための組成物若しくは組成物を含むパウチ、又は歯科衛生用品やチューインガム)を、医薬品の規制に関わる政府機関、例えば米国食品医薬品局や異なる自治体の相当する機関によって認可された表示と共に梱包する。
所望ならば、本発明のアレルゲン免疫療法製品の対象を減感作する効果を、アレルギーの症状及び/又は徴候を評価するために当該分野で知られている方法によって、評価することができる。いくつかの態様では、有効量とは、例えば、本発明の組成物や本発明の製品を使用しなかった場合に対象が経験すると予測されるか、対象がこれまでに経験した症状や発現のレベルと比較して、アレルゲンに曝露した場合に、1種以上のアレルギー症状や発現を軽減(軽減、低下など)及び/又は1種以上のアレルギー症状や発現(又は喘息やアレルギー性皮膚炎のような関連症状)が発症する可能性を低下させる量である。対象のアレルゲンに対する感受性は、例えばこれまでの場合や対象の病歴などに基づいて予測される場合と比較して、有意に低くなる。いくつかの態様では、症状の低下とは、例えばアレルギー症状に詳しい医師によって評価されるように、臨床上有意なものである。当業者は、アレルギー状態の症状や発現を理解している。一般的な(例えば大気中のアレルゲンに対する)アレルギー症状としては例えば、くしゃみ、鼻漏、鼻閉、鼻と眼の掻痒(かゆみ)、及び涙の分泌がある。症状、診断などに関する詳細は、Adkinson, NF, et al., Middleton's Allergy: Principles and Practice(ミドルトンのアレルギー:原理と実際), 7th edition (Mosby, 2008)などの標準的な教科書に記載されている。症状を、任意にアレルギーの重篤度を評価するための及び/又は、アレルギーの発現を軽減するための薬剤や方法の効果を評価するための、当該分野で公知の様々な方法のいずれかを用いて点数付けすることができる。例えばいくつかの態様では、鼻炎結膜炎症状スコア(Rhinoconjunctivitis Total Symptom Score、RTSS)、すなわち、くしゃみ、鼻漏、鼻のかゆみ、鼻閉、涙目、及び眼のかゆみの6つの症状の合計を用いる。例えば、参照により組み込まれる、Wahn U, et al., J Allergy Clin Immunol., 123(1):160-166, 2009、を参照のこと。いくつかの態様では、日本アレルギー性鼻炎照準QOL調査票(JRQLQ No. 1、Okubo上記)を用いてもよい。アレルギー症状を評価するのに適した多種多様の点数付けシステムを用いてもよいことを、当業者は分かっている。救急薬(例えば抗ヒスタミン剤)の使用を監視することができ、救急薬を使用した場合の要件の低下は、本発明の製品を使用した場合に得られる有効性の指標となる。効果を評価するための他の方法には、例えば、皮膚への曝露(例えば皮刺)、呼吸器への曝露、経口摂取などによる抗原チャレンジテストを実施し、それらに対する反応を、例えば、本発明のパウチや歯科衛生用品を使用した投与計画を開始する以前の反応と比較することがある。当業者に知られている適切な統計的検定(例えば、t検定、カイ二乗検定、ANOVA、など)を用いて、本発明の製品を使用することによって達成された統計的に有意な効果、例えば1以上の症状の低下、標準的な調査に基づく合計点の低下、救急薬の使用の低下などを示すことができる。いくつかの態様では、統計的な有意差はp値が<0.05であることを指す。いくつかの態様では、統計的な有意差はp値が<0.01であることを指す。
Claims (30)
- 対象によって該対象の口腔内に挿入されるための、そして該口腔の前庭粘膜の表面に固定して適合しうる軟質多孔性パウチであって、少なくとも1種のアレルゲンを含む徐放放出用に製剤化された組成物を含む、軟質多孔性パウチ。
- アレルゲンが花粉、イエダニ、カビ及び動物の鱗屑からなる群より選択される、請求項1に記載の軟質多孔性パウチ。
- 該対象がアレルギーの臨床症状を示しており、該アレルギーとの関連に基づいて1種以上のアレルゲンが選択される、請求項1に記載の軟質多孔性パウチ。
- 該花粉がブタクサ花粉であり、該アレルゲンがブタクサ花粉とイエダニからなる、請求項2に記載の軟質多孔性パウチ。
- 該徐放放出製剤が1種以上のアレルゲンを組み込んだマトリックスを含み、該マトリックスは唾液中で溶解することができ、それにより該1種以上のアレルゲンを該唾液中に放出することができ、前記マトリックスは生理学的に許容可能な賦形剤を含んでよく、該生理学的に許容可能な賦形剤はデンプン又は他の生理学的に許容可能な重合体を含んでよい、請求項1に記載の軟質多孔性パウチ。
- 使い捨ての単回使用パウチを含む、請求項1に記載の軟質多孔性パウチ。
- 一定の用量の組成物を受け入れて収容するのに適合された軟質多孔性パウチであって、該パウチに該用量を充填後は、対象によって該対象の口腔内に挿入されるのに適していて、かつ、該口腔の前庭粘膜の表面に適合することが可能になる、軟質多孔性パウチ。
- 対象の1種以上のアレルゲンへの感受性を下げ、アレルギー症状を軽減させるための方法であって、該アレルギーに関連する1種以上のアレルゲンを、比較的高濃度の樹状細胞を有する該口腔粘膜の領域に持続して曝露する工程を含む方法。
- 該口腔粘膜の領域が、前庭粘膜領域を実質的に含む、請求項8に記載の1種以上のアレルゲンに対する感受性を下げるための方法。
- 該口腔の前庭粘膜の表面に固定して適合しうる、少なくとも1種のアレルゲンを含む徐放放出用に製剤化された組成物を含む軟質多孔性パウチを挿入することにより持続した曝露を提供する、請求項9に記載の方法。
- 該1種以上のアレルゲンを含む歯科衛生用品を日常的に使用することにより、該持続した曝露を提供する、請求項8に記載の方法。
- 該歯科衛生用品が、歯磨き粉、練り歯磨き剤、口腔用スプレー、又は洗口剤である、請求項11に記載の方法。
- a)歯磨き粉、練り歯磨き剤、洗口剤又は口腔用スプレーの基剤とb)天然型又は抽出物として提供される少なくとも1種のアレルゲンを含む、免疫寛容の発現を誘導し、同時に口内の健康を増進する、歯磨き粉、練り歯磨き剤、洗口剤、又は口腔用スプレー組成物。
- 該1種以上のアレルゲンを含むゲルの適用により、該持続した曝露を提供する、請求項8に記載の方法。
- 該ゲルを就寝直前に該前庭粘膜の表面に適用する、請求項14に記載の方法。
- 該1種以上のアレルゲンと、唾液に曝されて溶解する親水性の重合体を含む口内用ストリップにより該持続した曝露を提供する請求項9に記載の方法であって、該口内用ストリップを就寝直前に該前庭粘膜の表面に適用する工程をさらに含む方法。
- 該少なくとも1種のアレルゲンが、花粉、イエダニ、カビ及び動物の鱗屑から選択される、請求項8〜16のいずれかに記載の方法。
- 該花粉がブタクサ花粉であり、該少なくとも1種のアレルゲンがブタクサ花粉とイエダニを含む、請求項17に記載の方法。
- 対象の環境アレルゲンに対するアレルギー反応を減少させる方法であって、該アレルギー反応に関連するアレルゲンを同定する工程、該同定したアレルゲンの抽出物と毒性のない有機増量剤を混合する工程、この混合物を軟質多孔性パウチに充填する工程、及び該パウチを前庭粘膜の表面に固定されて適合するように挿入する工程を含み、該充填したパウチは対象によって該対象の口腔内に挿入されるのに適しており、かつ、該口腔の前庭粘膜の表面に固定されて適合しうる、方法。
- 該同定されたアレルゲンが該対象の環境に由来する、請求項19に記載の方法。
- 請求項3に記載の複数の軟質多孔性パウチと、該対象の該少なくとも1種のアレルゲンに対する減感作に有効で、それによって該臨床症状の重篤度を緩和する投与計画を含む説明書を含むキット。
- 請求項7に記載の複数の軟質多孔性パウチと、一組の一般的な環境アレルゲンの、個々に含まれる複数の抽出物と、一定量の毒性のない有機増量剤と、抽出物を該増量剤と混合し、該軟質多孔性パウチに充填するための説明書とを含むキット。
- 該一組の一般的な環境アレルゲンの組成が該対象の環境に基づいている、請求項22に記載のキット。
- 歯科衛生組成物の製造方法であって、a)前記歯科衛生組成物用の基剤を準備する工程と、b)少なくとも1種のアレルゲンと前記基剤を合わせる工程を含み、さらに(c)組成物を分配するのに適した容器に前記歯科衛生組成物を入れる工程を含むことができ、該歯科衛生用品が歯磨き粉、洗口剤、口腔用スプレー、又は練り歯磨き剤であってよい、方法。
- 該アレルゲンがスギ(Cryptomeria japonica)花粉アレルゲン又はそれと免疫学的に交差反応するアレルゲンを含む、請求項1、2、3、5、6、又は7のいずれかに記載の軟質多孔性パウチ。
- 該アレルゲンがスギ花粉アレルゲン又はそれと免疫学的に交差反応するアレルゲンを含む、請求項8、9、10、11、12、14、15、16、17、18、19、又は24のいずれかに記載の方法。
- スギ花粉アレルゲン又はそれと免疫学的に交差反応するアレルゲンを含む歯科衛生用品又はチューインガムであって、該歯科衛生用品は、歯磨き粉、洗口剤、口腔用スプレー、又は練り歯磨き剤であってよい、歯科衛生用品又はチューインガム。
- 該アレルゲンが草花粉アレルゲン又はそれと免疫学的に交差反応するアレルゲンを含む、請求項1、2、3、5、6、又は7のいずれかに記載の軟質多孔性パウチ。
- 該アレルゲンが草花粉アレルゲン又はそれと免疫学的に交差反応するアレルゲンを含む、請求項8、9、10、11、12、14、15、16、17、18、19、又は24のいずれかに記載の方法。
- 草花粉アレルゲン又はそれと免疫学的に交差反応するアレルゲンを含む歯科衛生用品或いはチューインガムであって、該歯科衛生用品は、歯磨き粉、洗口剤、口腔用スプレー、又は練り歯磨き剤であってよい歯科衛生用品又はチューインガム。
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JP2016537299A (ja) * | 2013-09-19 | 2016-12-01 | アロヴェイト・エルエルシー | 口腔粘膜にアレルゲンを供給するための練り歯磨き |
JP2019142897A (ja) * | 2013-09-19 | 2019-08-29 | アロヴェイト・エルエルシー | 口腔粘膜にアレルゲンを供給するための練り歯磨き |
JP2021098705A (ja) * | 2013-09-19 | 2021-07-01 | アロヴェイト・エルエルシー | 口腔粘膜にアレルゲンを供給するための練り歯磨き |
JP7209425B2 (ja) | 2013-09-19 | 2023-01-20 | アロヴェイト・エルエルシー | 口腔粘膜にアレルゲンを供給するための練り歯磨き |
WO2019189676A1 (ja) * | 2018-03-30 | 2019-10-03 | 学校法人 川崎学園 | ヒアルロン酸を有効成分として含むアレルゲン作用増強剤 |
JPWO2019189676A1 (ja) * | 2018-03-30 | 2021-05-27 | 学校法人 川崎学園 | ヒアルロン酸を有効成分として含むアレルゲン作用増強剤 |
JP7337389B2 (ja) | 2018-03-30 | 2023-09-04 | 学校法人 川崎学園 | ヒアルロン酸を有効成分として含むアレルゲン作用増強剤 |
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TR201906326T4 (tr) | 2019-05-21 |
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US20160206731A1 (en) | 2016-07-21 |
JP6062851B2 (ja) | 2017-01-18 |
JP6239066B2 (ja) | 2017-11-29 |
WO2011137420A1 (en) | 2011-11-03 |
JP2019206589A (ja) | 2019-12-05 |
PT2563316T (pt) | 2019-05-27 |
AU2011245142A1 (en) | 2013-01-10 |
JP2016210794A (ja) | 2016-12-15 |
EP2563316B1 (en) | 2019-02-13 |
CN103025303A (zh) | 2013-04-03 |
CN107184971A (zh) | 2017-09-22 |
EP2563316A4 (en) | 2014-06-11 |
JP2018027975A (ja) | 2018-02-22 |
EP3524259A1 (en) | 2019-08-14 |
DK2563316T3 (da) | 2019-05-13 |
EP3524259B1 (en) | 2021-10-13 |
US20220280638A1 (en) | 2022-09-08 |
AU2011245142B2 (en) | 2016-10-06 |
AU2017200098A1 (en) | 2017-02-02 |
ES2723173T3 (es) | 2019-08-22 |
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