JP6539268B2 - 慢性潰瘍の新規治療 - Google Patents
慢性潰瘍の新規治療 Download PDFInfo
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- JP6539268B2 JP6539268B2 JP2016532032A JP2016532032A JP6539268B2 JP 6539268 B2 JP6539268 B2 JP 6539268B2 JP 2016532032 A JP2016532032 A JP 2016532032A JP 2016532032 A JP2016532032 A JP 2016532032A JP 6539268 B2 JP6539268 B2 JP 6539268B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
- A61K38/1729—Cationic antimicrobial peptides, e.g. defensins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/44—Medicaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0019—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
- A61L26/0085—Porous materials, e.g. foams or sponges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
Description
(a)LL−37またはその薬学的に許容される塩および1つまたはそれ以上の薬学的に許容される賦形剤または担体系を含む医薬製剤の、前記潰瘍への局所適用;ならびにその後の
(b)ドレッシングの適用
を含み、
前記製剤の前記適用は、前記潰瘍を治療するために創傷面積1cm2当たりに適用されるLL−37が約80μg未満であるLL−37の用量を創傷部位にもたらす、前記方法が提供される。
LLGDFFRKSKEKIGKEFKRIVQRIKDFLRNLVPRTES [配列番号1]
(i)製剤が、以下の性質を有する;および/または
(ii)製剤の適用頻度が、以下のようなものである
ことを含意または意味する:
潰瘍を治療するために創傷部位において働くLL−37の量は、各治療日につき創傷面積1cm2当たり約26.7μgを超えない。
(a)LL−37および1つまたはそれ以上の薬学的に許容される賦形剤または担体系を含む医薬製剤の、前記潰瘍への局所適用;ならびにその後の
(b)ドレッシングの適用
を含み、
前記製剤の前記適用は、前記潰瘍を治療するために各治療日につき創傷面積1cm2当たりに適用されるLL−37が約26.7μg未満であるLL−37の用量(例えば、約13.3μgから約26.7μgの間である値未満である用量)を創傷部位にもたらす、前記方法が提供される。
二重盲検、無作為化、プラセボ対照、第I/II相安全性およびパイロット用量反応試験を、ヒト対象について行った。最初の対象は2012年8月に登録され、最後の対象は2013年4月に完了した。
試験対象は、VLUまたは静脈成分優位性の静脈性−動脈性混合型潰瘍を有する、少なくとも18歳の男性対象または閉経後もしくは臨床的不妊症の女性を含んだ。
上記の導入期後、4週間の治療期間が開始され、これには、8回の来院、最後の治療から3日(±1日)後の治療終了時の来院およびさらなる4週(±1〜7日)後の追跡来院が含まれた。
・ 炎症の臨床的徴候(浮腫、発赤、臭気および温度上昇)または皮膚の刺激状態(落屑、発赤、丘疹、小水疱、膿疱)によって例示されるような、創傷および隣接皮膚における重症の局所反応の発生率;いずれの局所反応も、等級化した尺度(0〜3)で記録された;
・ ベースライン(無作為化来院)と比較して、創傷面積の30%を超える増加の発生率;
・ ベースラインからの臨床検査値およびバイタルサインの変化;
・ AEの全発生率
を含んだ。
・ 試験期間内の創傷治癒率;
・ 無作為化時のベースラインからの30%を超える面積縮小を達成している潰瘍の数;および
・ VASスコア(0〜10)を使用した局所疼痛の変化
・ ベースラインからの創傷の特徴:(スラフ、滲出液、肉芽形成組織、壊死のスコア)の変化(尺度0〜3)
を含んだ。
統計解析は、SAS(登録商標)ソフトウェア(バージョン9.2以上;SAS Institute、Cary、NC、US)を使用して実施した。
Y=α×e−βt
[式中、αは、初期の創傷面積(すなわち無作為化来院時)を意味し、βは、1日当たりの治癒率として表されるサイズの縮小を意味し、Yは、創傷面積を意味し、tは、無作為化来院からの時間(日)を意味する]という形を有した。
合計31名の対象が、8回の治療適用の全クールを受けた。残りの3名の対象のうち、2名(0.5mg/mL治療群)は、7回の適用を受け、1名の対象(プラセボ群)は、3回の適用を受けた。
より低い2つの用量(0.5および1.6mg/mL)のLL−37の投与に応答した創傷治癒が、顕著にかつ有意に改善されていることが観察された。この試験の結果は、3日毎の0.5(創傷面積1cm2当たり13μgのLL−37に等しい)および1.6mg/mL(創傷面積1cm2当たり40μgのLL−37に等しい)の用量が、創傷治癒の有意な刺激をもたらすことを示唆している。あるいは、より高用量をより低頻度で適用することが適切な可能性もある。
Claims (9)
- 慢性潰瘍の局所治療に使用するための、治療有効量の配列番号1のペプチドLL−37またはその薬学的に許容される塩および1つまたはそれ以上の薬学的に許容される添加剤および/または賦形剤を含む水性医薬製剤であって、
(i)ここで、前記水性医薬製剤は、約1から約25Pa・sの範囲の製剤の粘度を与える増粘剤を含み;
(ii)ここで、創傷面積1cm 2 当たりに局所適用されるLL−37の用量は、約1μg/cm 2 から約70μg/cm 2 の間であり;および
(iii)ここで、ドレッシングが、前記慢性潰瘍に、前記水性医薬製剤を適用した後に、局所適用される、
前記水性医薬製剤。 - 製剤の粘度は、約1から約10Pa・sの範囲である、請求項1に記載の水性医薬製剤。
- 緩衝化されている、請求項1または2に記載の水性医薬製剤。
- 創傷面積1cm 2 当たりに適用されるLL−37の用量は、約5μg/cm2から約60μg/cm2の間である、請求項1〜3のいずれか1項に記載の水性医薬製剤。
- 創傷面積1cm 2 当たりに適用されるLL−37の用量は、治療1日につき約0.3μg/cm2から約23.3μg/cm2の間である、請求項1〜4のいずれか1項に記載の水性医薬製剤。
- 創傷面積1cm 2 当たりに局所適用されるLL−37の用量は、治療1日につき約1.6μg/cm2から約20μg/cm2の間である、請求項5に記載の水性医薬製剤。
- 潰瘍は、静脈性下腿潰瘍である、請求項1〜6のいずれか1項に記載の水性医薬製剤。
- 潰瘍は、糖尿病性足部潰瘍である、請求項1〜6のいずれか1項に記載の水性医薬製剤。
- ポリビニルアルコールを含む、請求項1〜8のいずれか1項に記載の水性医薬製剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/GB2013/053053 WO2015075406A1 (en) | 2013-11-19 | 2013-11-19 | New treatment of chronic ulcers |
GBPCT/GB2013/053053 | 2013-11-19 | ||
PCT/GB2014/053415 WO2015075441A1 (en) | 2013-11-19 | 2014-11-19 | New treatment of chronic ulcers |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2016537373A JP2016537373A (ja) | 2016-12-01 |
JP6539268B2 true JP6539268B2 (ja) | 2019-07-03 |
Family
ID=49998562
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2016532032A Active JP6539268B2 (ja) | 2013-11-19 | 2014-11-19 | 慢性潰瘍の新規治療 |
Country Status (15)
Country | Link |
---|---|
US (3) | US10226508B2 (ja) |
EP (1) | EP3071216B1 (ja) |
JP (1) | JP6539268B2 (ja) |
KR (1) | KR102360938B1 (ja) |
CN (1) | CN105939726A (ja) |
AU (1) | AU2014351607B2 (ja) |
BR (1) | BR112016011166A8 (ja) |
CA (1) | CA2927557C (ja) |
ES (1) | ES2925876T3 (ja) |
MX (1) | MX2016006091A (ja) |
PL (1) | PL3071216T3 (ja) |
RU (1) | RU2707254C1 (ja) |
TW (1) | TWI698251B (ja) |
WO (2) | WO2015075406A1 (ja) |
ZA (1) | ZA201604110B (ja) |
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GB0808376D0 (en) | 2008-05-08 | 2008-06-18 | Bristol Myers Squibb Co | Wound dressing |
GB0817796D0 (en) | 2008-09-29 | 2008-11-05 | Convatec Inc | wound dressing |
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JP5965409B2 (ja) | 2010-12-08 | 2016-08-03 | コンバテック・テクノロジーズ・インコーポレイテッドConvatec Technologies Inc | 創傷滲出液を評価するための統合システム |
JP6151186B2 (ja) | 2010-12-08 | 2017-06-21 | コンバテック・テクノロジーズ・インコーポレイテッドConvatec Technologies Inc | 創傷滲出液システム付属装置 |
GB201115182D0 (en) | 2011-09-02 | 2011-10-19 | Trio Healthcare Ltd | Skin contact material |
GB2497406A (en) | 2011-11-29 | 2013-06-12 | Webtec Converting Llc | Dressing with a perforated binder layer |
GB201120693D0 (en) | 2011-12-01 | 2012-01-11 | Convatec Technologies Inc | Wound dressing for use in vacuum therapy |
BR112015014816A2 (pt) | 2012-12-20 | 2017-07-11 | Convatec Technologies Inc | processamento de fibras celulósicas modificadas quimicamente |
WO2015075406A1 (en) | 2013-11-19 | 2015-05-28 | Lipopeptide Ab | New treatment of chronic ulcers |
WO2017212345A2 (en) | 2016-03-30 | 2017-12-14 | Synovo Gmbh | Detecting microbial infection in wounds |
PL3435941T3 (pl) | 2016-03-30 | 2022-05-09 | Convatec Technologies Inc. | Wykrywanie infekcji drobnoustrojowych w ranach |
AU2017292876B2 (en) | 2016-07-08 | 2022-01-20 | Convatec Technologies Inc. | Fluid collection apparatus |
KR20190026858A (ko) | 2016-07-08 | 2019-03-13 | 컨바텍 테크놀러지스 인크 | 가요성 부압 시스템 |
ES2912094T3 (es) | 2016-07-08 | 2022-05-24 | Convatec Technologies Inc | Detección de flujo de fluidos |
US11795192B2 (en) | 2017-03-10 | 2023-10-24 | Lakewood Amedex, Inc. | Antimicrobial compounds, compositions, and uses thereof |
CN110753549A (zh) | 2017-06-12 | 2020-02-04 | 莱克伍德阿美达克斯股份有限公司 | 双磷脂素凝胶制剂及其用途 |
SG11202103180QA (en) | 2018-10-17 | 2021-05-28 | Lakewood Amedex Inc | Methods and compositions for treating oral mucositis |
US11331221B2 (en) | 2019-12-27 | 2022-05-17 | Convatec Limited | Negative pressure wound dressing |
US11771819B2 (en) | 2019-12-27 | 2023-10-03 | Convatec Limited | Low profile filter devices suitable for use in negative pressure wound therapy systems |
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WO2015075406A1 (en) | 2013-11-19 | 2015-05-28 | Lipopeptide Ab | New treatment of chronic ulcers |
-
2013
- 2013-11-19 WO PCT/GB2013/053053 patent/WO2015075406A1/en active Application Filing
-
2014
- 2014-11-14 TW TW103139532A patent/TWI698251B/zh active
- 2014-11-19 US US15/037,199 patent/US10226508B2/en active Active
- 2014-11-19 AU AU2014351607A patent/AU2014351607B2/en active Active
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US20160271217A1 (en) | 2016-09-22 |
US10226508B2 (en) | 2019-03-12 |
US11191810B2 (en) | 2021-12-07 |
BR112016011166A2 (ja) | 2017-08-08 |
TWI698251B (zh) | 2020-07-11 |
ZA201604110B (en) | 2020-11-25 |
RU2707254C1 (ru) | 2019-11-25 |
AU2014351607A1 (en) | 2016-06-23 |
PL3071216T3 (pl) | 2022-11-21 |
MX2016006091A (es) | 2016-12-09 |
KR102360938B1 (ko) | 2022-02-09 |
CA2927557A1 (en) | 2015-05-28 |
US20190255147A1 (en) | 2019-08-22 |
CN105939726A (zh) | 2016-09-14 |
AU2014351607B2 (en) | 2020-03-05 |
WO2015075441A1 (en) | 2015-05-28 |
US10709760B2 (en) | 2020-07-14 |
EP3071216B1 (en) | 2022-08-03 |
WO2015075406A1 (en) | 2015-05-28 |
CA2927557C (en) | 2023-05-02 |
ES2925876T3 (es) | 2022-10-20 |
US20200384077A1 (en) | 2020-12-10 |
RU2016124234A (ru) | 2017-12-25 |
JP2016537373A (ja) | 2016-12-01 |
TW201521760A (zh) | 2015-06-16 |
KR20160088914A (ko) | 2016-07-26 |
BR112016011166A8 (pt) | 2022-06-28 |
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