WO2006138691A1 - Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy - Google Patents

Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy Download PDF

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Publication number
WO2006138691A1
WO2006138691A1 PCT/US2006/023708 US2006023708W WO2006138691A1 WO 2006138691 A1 WO2006138691 A1 WO 2006138691A1 US 2006023708 W US2006023708 W US 2006023708W WO 2006138691 A1 WO2006138691 A1 WO 2006138691A1
Authority
WO
WIPO (PCT)
Prior art keywords
vasoconstrictor
skin
topical
delivery vehicle
norepinephrine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2006/023708
Other languages
English (en)
French (fr)
Inventor
William E. Fahl
Arnold E. Ruoho
Minesh Mehta
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wisconsin Alumni Research Foundation
Original Assignee
Wisconsin Alumni Research Foundation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to EP06773476.4A priority Critical patent/EP1890732B1/en
Priority to PL06773476T priority patent/PL1890732T3/pl
Priority to CA2611496A priority patent/CA2611496C/en
Priority to AU2006261358A priority patent/AU2006261358B2/en
Priority to PL13157485T priority patent/PL2656860T3/pl
Priority to DK06773476.4T priority patent/DK1890732T3/en
Priority to CN200680021549.2A priority patent/CN101198362B/zh
Priority to EP13157485.7A priority patent/EP2656860B1/en
Application filed by Wisconsin Alumni Research Foundation filed Critical Wisconsin Alumni Research Foundation
Priority to JP2008517201A priority patent/JP5756250B2/ja
Priority to ES06773476.4T priority patent/ES2675228T3/es
Publication of WO2006138691A1 publication Critical patent/WO2006138691A1/en
Anticipated expiration legal-status Critical
Priority to IL191869A priority patent/IL191869A/en
Priority to IL232904A priority patent/IL232904A/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications

Definitions

  • protective therapies that promote routine growth and proliferation of normal cells in the presence of radiotherapy or chemotherapeutic agents will permit the use of higher dose, more aggressive cancer therapy. Consequently, these protective therapies may not only address the side-effects of cancer and its treatment, but may enable greater treatment efficacy against cancer than is seen using current therapies.
  • the undesired cardiac side-effects of systemically-distributed ⁇ and ⁇ agonists are well known, although the distant protection of tumor cells by a systemically-distributed vasoconstrictor is possible.
  • the methods and compositions taught herein provide desired local vasoconstrictor effects in skin or mucosa while avoiding side-effects stemming from systemic administration.
  • the intended protection of normal tissue involves an appropriately chosen vasoconstrictor in combination with an appropriate delivery vehicle, chosen and optimized for a specific administration site (e.g. skin, oral mucosa , rectal mucosa, or the like). Because of the choices of vasoconstrictors and delivery vehicle components that are available, a topically-formulated vasoconstrictor can be used to protect any normal cell type susceptible to the side-effects of cancer therapy that is accessible by topical delivery.
  • Solution-based delivery systems are ideal for the delivery of small organic molecules.
  • alcohol-containing solutions are particularly well suited.
  • An aqueous alcohol-based delivery vehicle was proven effective for topical administration of vasoconstrictors (Examples 1, 2, 3, 4).
  • Other advantages of this delivery system include, ease of manufacturing, fast drying on the skin, and ease of analysis of active drug compound after formulation.
  • Mucositis Severity Scores are assigned on day 16 following irradiation. The aggregate score incorporates sub-scores for erythema (0-5), edema (0-4), tissue rigidity (0-4) and pseudomembrane formation (0-4). Mucositis Severity Scores in the 11-13 range are similar in severity to a human Grade 3 mucositis. At an 11-13 score diffuse patches of pseudomembranous ulcers are visible, as well as severe erythema and edema; the pouches also become more rigid and are less amenable to spreading over the plastic disks.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Toxicology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PCT/US2006/023708 2005-06-17 2006-06-19 Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy Ceased WO2006138691A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CN200680021549.2A CN101198362B (zh) 2005-06-17 2006-06-19 在癌症化疗和放疗时保护细胞的局部血管收缩剂制品和方法
CA2611496A CA2611496C (en) 2005-06-17 2006-06-19 Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy
AU2006261358A AU2006261358B2 (en) 2005-06-17 2006-06-19 Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy
PL13157485T PL2656860T3 (pl) 2005-06-17 2006-06-19 Preparaty środka zwężającego naczynia i sposoby ochrony komórek podczas chemioterapii i radioterapii przeciwnowotworowej
DK06773476.4T DK1890732T3 (en) 2005-06-17 2006-06-19 TOPICAL VASO CONSTRUCTOR PREPARATIONS AND METHODS FOR PROTECTING CELLS UNDER CANCER THERAPY AND RADIATION THERAPY
EP13157485.7A EP2656860B1 (en) 2005-06-17 2006-06-19 Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy
JP2008517201A JP5756250B2 (ja) 2005-06-17 2006-06-19 癌の化学療法および放射線療法の際に細胞を保護するための局所的血管収縮剤および方法
EP06773476.4A EP1890732B1 (en) 2005-06-17 2006-06-19 Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy
PL06773476T PL1890732T3 (pl) 2005-06-17 2006-06-19 Preparaty zwężające naczynia krwionośne do podawania miejscowego i sposoby ochrony komórek podczas chemioterapii i radioterapii przeciwnowotworowej
ES06773476.4T ES2675228T3 (es) 2005-06-17 2006-06-19 Preparaciones tópicas de vasoconstrictores y métodos para proteger a las células durante la quimioterapia y radioterapia del cáncer
IL191869A IL191869A (en) 2005-06-17 2008-06-01 Blood Vessel Remedies and Cell Protection Methods for Chemotherapy and Cancer Therapy
IL232904A IL232904A (en) 2005-06-17 2014-06-01 Blood Vessel Remedies and Cell Protection Methods for Chemotherapy and Cancer Therapy

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US69157105P 2005-06-17 2005-06-17
US60/691,571 2005-06-17

Publications (1)

Publication Number Publication Date
WO2006138691A1 true WO2006138691A1 (en) 2006-12-28

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PCT/US2006/023708 Ceased WO2006138691A1 (en) 2005-06-17 2006-06-19 Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapy

Country Status (15)

Country Link
US (4) US8114914B2 (enExample)
EP (2) EP1890732B1 (enExample)
JP (4) JP5756250B2 (enExample)
CN (3) CN107496925A (enExample)
AU (1) AU2006261358B2 (enExample)
CA (1) CA2611496C (enExample)
DK (2) DK1890732T3 (enExample)
ES (2) ES2675228T3 (enExample)
HK (1) HK1245143A1 (enExample)
HU (2) HUE038177T2 (enExample)
IL (2) IL191869A (enExample)
PL (2) PL2656860T3 (enExample)
PT (2) PT2656860T (enExample)
TR (1) TR201809015T4 (enExample)
WO (1) WO2006138691A1 (enExample)

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EP2713988A4 (en) * 2011-06-02 2015-03-04 Procertus Biopharm Inc FORMULATION OF SMALL FORMS OF SALTS OF ADRENERGIC AGONISTS IN ORGANIC SOLVENTS
WO2019014518A1 (en) * 2017-07-14 2019-01-17 Galderma Research And Development METHODS AND COMPOSITIONS FOR REDUCING ADVERSE EFFECTS OF CHEMOTHERAPEUTIC TREATMENTS
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