JP2018510902A - 創傷治癒調節のための製剤および方法 - Google Patents
創傷治癒調節のための製剤および方法 Download PDFInfo
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Abstract
Description
本発明は、概して細胞生物学の分野に関し、より詳細には、創傷または皮膚に関連する疾患または状態を治療するためにオートファジーを調節するための化合物、製剤、および方法に関する。オートファゴサイトーシスとしても知られる「オートファジー」という名称は、「食べる」と「自己」を意味するギリシャ語に由来する。オートファジーは、一般に自己消化と定義される。
例えば、角度、成分の量、ポリマー分子量、反応条件(pH、温度、電荷レベルなど)、物理的寸法など、本発明を特徴付けるために使用される数値範囲、測定値、およびパラメーターは、必然的に近似値であり、できるだけ正確に報告されているものの、それぞれの測定値に由来する不正確さを本質的に含む。したがって、明細書および特許請求の範囲で使用される大きさの範囲を表す全ての数字は、全ての場合において「約」という用語によって修飾されるものとして理解されるべきである。全ての数値範囲は、その範囲の外側境界内の全ての可能な漸増の部分範囲を含むと理解される。したがって、30〜90単位の範囲は、例えば、35〜50単位、45〜85単位、および40〜80単位などを開示する。他に定義されない限り、パーセンテージは、重量/重量(wt/wt)であり、処方は、概して、重量/容量(w/v)、100mLあたりのグラム数(密度1.0の水溶液ではwt/wtに相当)であり、創傷面積は、面積/面積(a/a)としてcm2で表されている。
化学的および生物学的定義
RaおよびRbは、独立して、H、または−(R3)pもしくは−(R4)qで置換されていてもよいフェニルであり、
R1〜R4は、独立して、フェニル環の任意の利用可能な位置の置換基であり、
m、n、p、およびqは、それぞれ独立して、環の置換基の数を表す0、1、2、または3であり、mまたはnの少なくとも1つは≧1でなければならず、
各R1、R2、R3、およびR4は、独立して、
(C1〜C6)アルキル、(C2〜C6)アルケニル、または(C2〜C6)アルキニルから選択され、−OH、−SH、−ハロ、−NH2、またはNO2から選択される1〜3個の置換基で置換されていてもよい−R5、
YがO、S、またはNHであり、R6がHまたはR5から選択される−YR6、
Zが−N(C=O)−または−O(C=O)−である−ZR5、
−ハロ、
−NO2、
−SO3Na、
−アジド、および
−グリコシド
−ならびにこれらの塩、
から選択され、
但し、FAMはレスベラトロールまたは4,4’−(エチン−1,2−ジイル)ジフェノール(TOLCINE)ではない。
第1のオートファジー調節剤(FAM)
補助的オートファジー調節剤(AAM)および製剤
ビタミン
アミノ酸
酸性糖
キノン誘導体
オートファジー調節におけるFAMおよびAAMの有用性
Claims (32)
- 慢性創傷または皮膚状態を有する患者における創傷治癒を促進するための方法であって、
構造(I)を有する第1のオートファジー調節化合物であって、
RaおよびRbは、独立して、H、または−(R3)pもしくは−(R4)qで置換されていてもよいフェニルであり;
R1〜R4は、独立して、フェニル環の任意の利用可能な位置の置換基であり、
m、n、p、およびqは、それぞれ独立して、環の置換基の数を表す0、1、2、または3であり、mまたはnの少なくとも1つは≧1でなければならず、
各R1、R2、R3、およびR4は、独立して、
(C1−C6)アルキル、(C2−C6)アルケニル、または(C2−C6)アルキニルから選択され、−OH、−SH、−ハロ、−NH2、またはNO2から選択される1〜3個の置換基で置換されていてもよい−R5、
YがO、S、またはNHであり、R6がHまたはR5から選択される−YR6、
Zが−N(C=O)−または−O(C=O)−である−ZR5、
−ハロ、
−NO2、
−SO3Na、
−アジド、および
−グリコシド
−ならびにこれらの塩、
から選択され、
レスベラトロールまたは4,4’−(エチン−1,2−ジイル)ジフェノール(TOLECINE、4,4’−ジヒドロキシトランとしても知られている)ではない前記第1のオートファジー調節化合物を含んでなる治療有効量の製剤を患者に投与することを含んでなる、前記方法。 - 前記第1のオートファジー調節化合物が、Lが−C≡C−であるトランである、請求項1に記載の方法。
- 前記トランが、1〜4個のヒドロキシル置換基を有する、ヒドロキシル化トランである、請求項2に記載の方法。
- 前記トランが、2,4,4’−トリヒドロキシトラン、4,3’,5’−トリヒドロキシトラン、2,2’,4,4’−テトラヒドロキシトラン、3,3’,5,5’−テトラヒドロキシトラン、および4−ヒドロキシ−4’−(トリフルオロ)メチルトランから選択される、請求項3に記載の方法。
- 前記トランが、4,4’−ジヒドロキシ−3−メトキシトラン、2,4,4’−トリヒドロキシトラン−ベータ−D−グルコシド、および4−ヒドロキシ−4’−メトキシトランから選択される、請求項3に記載の方法。
- 前記第1のオートファジー調節化合物が、Lが−CH=CH−であるトランス−スチルベンである、請求項1に記載の方法。
- 前記スチルベンが、1〜4個のヒドロキシル置換基を有するヒドロキシル化スチルベンである、請求項6に記載の方法。
- 補助的オートファジー調節化合物の併用投与をさらに含んでなる、請求項1〜7のいずれか一項に記載の方法。
- 前記補助的オートファジー調節化合物を前記第1のオートファジー調節化合物と同時に投与する、請求項8に記載の方法。
- 前記補助的オートファジー調節化合物を前記第1のオートファジー調節化合物を投与する前に投与する、請求項8に記載の方法。
- 前記補助的オートファジー調節化合物が、置換型または非置換型パラベンゾキノン、置換型または非置換型オルトベンゾキノン、および置換型または非置換型アントラキノンからなる群から選択される、請求項8に記載の方法。
- 前記補助的オートファジー調節化合物が、アミノ酸、酸性単糖、およびビタミンまたはその塩からなる群から選択される、請求項8に記載の方法。
- 前記ビタミンが酸素含有ビタミンである、請求項12に記載の方法。
- 前記ビタミンがイソプレノイド含有ビタミンである、請求項12に記載の方法。
- 前記第1のオートファジー調節化合物が、オートファジー活性をアップレギュレートする、請求項1に記載の方法。
- 前記創傷または皮膚の状態が、老化、炎症を伴う自己免疫疾患、無血管壊死、細菌感染、癌、糖尿病性神経障害、子宮内膜症、真菌感染症、痛風、脱毛、感染性関節炎、炎症、炎症性腸疾患、虚血、ライム病、器官/組織移植、寄生虫感染、乾癬性関節炎、乾癬、偽痛風、関節リウマチ、強皮症、壊血病、敗血症、皮膚疾患、手術瘢痕、外科的癒着、トランスフェクション法、潰瘍性大腸炎、潰瘍、ウイルス感染、疣贅、手術創傷、切開、裂傷、切り傷および擦り傷、皮膚移植による供与部創傷、外傷性創傷、感染性創傷、虚血性創傷、火傷、水疱性創傷、非感染創傷、打撲傷、切創、裂傷、非貫通創、開いた創傷、貫通創、穿孔創、刺創、膿創、皮下創、慢性潰瘍、胃潰瘍、皮膚潰瘍、消化性潰瘍、十二指腸潰瘍、胃潰瘍、痛風、高血圧性虚血性潰瘍、鬱血性潰瘍、舌下潰瘍、粘膜下潰瘍、症候性潰瘍、栄養性潰瘍、熱帯性潰瘍、および性病性潰瘍から選択される1つ以上である、請求項1または15に記載の方法。
- オートファジーの調節の必要性を生じさせる状態、障害、または疾患が、角化症、光老化、乾癬、皮膚発疹、日焼け、および光反応過程などの1つ以上の皮膚病である、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、口腔内のびらんおよび熱傷、抜歯後創傷、特に嚢胞および膿瘍の治療に関連する歯内創傷、細菌性、ウイルス性、または自己免疫性起源の潰瘍および病変、機械的、化学的、熱的、感染性、および苔癬状創傷、ヘルペス潰瘍、アフタ性口内炎、急性壊死性潰瘍性歯肉炎および口腔内灼熱症などの損傷した口腔組織の治癒を保護および促進するために口腔洗浄剤またはスプレーの形態で経口的に使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、角膜潰瘍、放射状角膜切開、角膜移植、エピケラトファキア、および他の手術により誘発された眼内の創傷に起因する創傷などの創傷を治療するために眼科用製剤に使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、掻痒症、直腸炎、肛門裂傷、および痔核などの状態を治療するために肛門直腸クリームおよび座薬に使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、以下の効果:保湿および保護、乾いた割れた肌の治癒、他の疾患による重度の乾燥肌(静脈皮膚炎)の治癒、UV光損傷からの皮膚の保護、および脂漏性状態の治療のために使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、熱傷、炭疽病、破傷風、ガス壊疽、猩紅熱(scalatina)、丹毒、ひげ毛瘡、毛嚢炎、伝染性膿痂疹、または水疱性膿痂疹などである、本発明により成功裏に治療され得る創傷またはびらんに関連する状態を治療するために使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、皮膚における老化の徴候の少なくとも1つを治療することであって、前記皮膚の弾力性を向上させること、前記皮膚の堅さを向上させること、および前記皮膚のしわまたはセルライトの出現を減少させることからなる群から選択されること、および/または(ii)前記皮膚の非座瘡形成性炎症を治療することに使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 前記状態、障害、または疾患が、例えば、放射線および/または化学療法から生じる口腔および口腔傍潰瘍治療として使用してもよい1つ以上の前記オートファジー調節剤の必要性を生じさせる、請求項1または15に記載の方法。
- 請求項1〜7のいずれか1項に記載の第1のオートファジー調節化合物をヒドロゲル中に分散して含んでなる製剤。
- 前記ヒドロゲルが、前記第1のオートファジー調節化合物によって部分的に形成された液晶性ヒドロゲルである、請求項25に記載の製剤。
- 前記ヒドロゲルがアルギン酸塩である、請求項25に記載の製剤。
- 約1:1〜約1:10の第1のオートファジー調節化合物:シクロデキストリンの比でシクロデキストリンと組み合わされた請求項1〜7のいずれか一項に記載の第1のオートファジー調節化合物を含んでなる製剤。
- アスコルビン酸およびカチオンとの複合体に組み込まれた、請求項1〜7のいずれか1項に記載の第1のオートファジー調節化合物を含んでなる製剤。
- 患者に治療有効量の製剤を投与することを含んでなる、オートファジー調節を必要とする患者におけるオートファジーを調節するための方法であって、前記製剤が、
構造(I)を有する第1のオートファジー調節化合物を含んでなり、
RaおよびRbは、独立して、H、または−(R3)pもしくは−(R4)qで置換されていてもよいフェニルであり;
R1〜R4は、独立して、フェニル環の任意の利用可能な位置の置換基であり、
m、n、p、およびqは、それぞれ独立して、環の置換基の数を表す0、1、2、または3であり、mまたはnの少なくとも1つは≧1でなければならず、
各R1、R2、R3、およびR4は、独立して、
(C1〜C6)アルキル、(C2〜C6)アルケニル、または(C2〜C6)アルキニルから選択され、−OH、−SH、−ハロ、−NH2、またはNO2から選択される1〜3個の置換基で置換されていてもよい−R5、
YがO、S、またはNHであり、R6がHまたはR5から選択される−YR6、
Zが−N(C=O)−または−O(C=O)−である−ZR5、
−ハロ、
−NO2、
−SO3Na、
−アジド、および
−グリコシド、
ならびにこれらの塩、
から選択される、前記方法。 - 前記患者がオートファジーアップレギュレーションを必要とする状態に罹患しており、前記状態が、創傷治癒、毛髪再成長、細菌感染、炎症、ウイルス感染、パーキンソン病、老化、アルツハイマー、神経変性疾患、神経障害、循環器疾患、熱傷、心臓病、アルツハイマー病、アテローマ性動脈硬化症、動脈硬化症、慢性閉塞性肺疾患(COPD)、クローン病、炎症性腸疾患、大腸炎、糖尿病、I型およびII型糖尿病、アミロイドーシス、滑液包炎、皮膚炎、血管炎、炎症を伴う自己免疫疾患、血液疾患、再生不良性貧血、子宮内膜症、肝炎、ヘルペス、HIV、多発性硬化症、網膜剥離、老化性黄斑変性症、網膜色素変性、およびレーバー先天性黒内障、リソソーム蓄積症、関節炎、乾癬、骨減少症、骨粗鬆症、手術瘢痕、外科的癒着、宇宙旅行(骨密度障害)、腱炎、および潰瘍性大腸炎のうち1つ以上を含んでなる、請求項30に記載の方法。
- 前記患者がオートファジーダウンレギュレーションを必要とする状態に罹患しており、前記状態が、老化、癌、多嚢胞腎および肝疾患、腎疾患、肝疾患、喘息、糖尿病性網膜症、線維筋痛症、強直性脊椎炎、セリアック病、グレーブス病、狼瘡、代謝性疾患、腎炎、関節リウマチ、骨溶解、虚血−再灌流(I/R)障害、臓器および組織移植、強皮症、および敗血症のうち1つ以上を含んでなる、請求項30に記載の方法。
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US10426742B2 (en) | 2019-10-01 |
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US20160296477A1 (en) | 2016-10-13 |
AU2016246616B2 (en) | 2021-04-01 |
JP6927884B2 (ja) | 2021-09-01 |
HK1251836A1 (zh) | 2019-04-12 |
CN107847466B (zh) | 2024-02-06 |
WO2016164531A3 (en) | 2016-11-17 |
EP3280402A2 (en) | 2018-02-14 |
BR112017021271A2 (pt) | 2018-06-26 |
EP3280402B1 (en) | 2024-06-05 |
EP3280402A4 (en) | 2019-04-03 |
KR20170141705A (ko) | 2017-12-26 |
CN107847466A (zh) | 2018-03-27 |
SG11201707919QA (en) | 2017-10-30 |
US20200016096A1 (en) | 2020-01-16 |
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IL254863A0 (en) | 2017-12-31 |
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