EP2054069A2 - Verwendung eines gingko-biloba-extrakts zur behandlung von mitochondrienerkrankungen genetischen ursprungs - Google Patents

Verwendung eines gingko-biloba-extrakts zur behandlung von mitochondrienerkrankungen genetischen ursprungs

Info

Publication number
EP2054069A2
EP2054069A2 EP07823343A EP07823343A EP2054069A2 EP 2054069 A2 EP2054069 A2 EP 2054069A2 EP 07823343 A EP07823343 A EP 07823343A EP 07823343 A EP07823343 A EP 07823343A EP 2054069 A2 EP2054069 A2 EP 2054069A2
Authority
EP
European Patent Office
Prior art keywords
weight
use according
ginkgo biloba
flavone
glycosides
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.)
Withdrawn
Application number
EP07823343A
Other languages
English (en)
French (fr)
Inventor
Arnold Munnich
François CLOSTRE
Mehemed Ouzid
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.)
Ipsen Pharma SAS
Original Assignee
Ipsen Pharma SAS
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
Application filed by Ipsen Pharma SAS filed Critical Ipsen Pharma SAS
Publication of EP2054069A2 publication Critical patent/EP2054069A2/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism

Definitions

  • the present application relates to the use of a Ginkgo biloba extract for preparing a medicament for treating or preventing mitochondrial diseases of genetic origin.
  • Mitochondrial diseases are relatively common pathologies in the group of inherited metabolic diseases. They are due to a dysfunction of the mitochondrial respiratory chain. Among the mitochondrial diseases, we can distinguish those of genetic origin and in particular the mitochondrial encephalomyopathies which affect the muscle and nervous system and the hereditary optic neuropathy of Leber.
  • Mitochondrial encephalomyopathies include diseases related to mitochondrial DNA abnormalities such as MERRF (or Myoclonic Epilepsy Associated with Ragged-Red Fibers), MELAS (or Mitochondrial Myopathy, Encephalopathy, Lactic Acidosis and Stroke-like episodes), Kearns-Sayre syndrome, Leigh syndrome; also diseases caused by nuclear genome abnormalities including various forms of Leigh syndromes and diseases caused by abnormalities of other mitochondrial protein genes such as hereditary spastic paraplegia and Friedreich ataxia (Ann Pathol 2005). 25, 282-291).
  • MERRF Myoclonic Epilepsy Associated with Ragged-Red Fibers
  • MELAS or Mitochondrial Myopathy, Encephalopathy, Lactic Acidosis and Stroke-like episodes
  • Kearns-Sayre syndrome Leigh syndrome
  • diseases caused by nuclear genome abnormalities including various forms of Leigh syndromes and diseases caused by abnormalities of other mitochondrial protein genes such as hereditary spastic
  • the invention therefore relates to the use of a Ginkgo biloba extract for preparing a medicament for treating or preventing mitochondrial encephalomyopathies.
  • the invention relates to the use of a Ginkgo biloba extract for preparing a medicament for treating or preventing mitochondrial encephalomyopathies related to mitochondrial DNA abnormalities.
  • these mitochondrial encephalomyopathies are chosen from MERRF syndrome and MELAS syndrome, and in particular MELAS syndrome.
  • the invention relates to the use of a Ginkgo biloba extract for preparing a medicament for treating or preventing mitochondrial encephalomyopathies related to abnormalities of other mitochondrial protein genes.
  • this mitochondrial encephalomyopathy is Friedreich's ataxia.
  • the Ginkgo biloba extracts that can be used according to the present invention are extracts comprising flavone-glycosides and / or one or more terpene lactones.
  • the flavone glycosides and / or the terpenes-lactones are present at least up to 24% by weight and more preferably at least up to 30%.
  • the proportion of alkylphenol type compounds in the Ginkgo biloba extract used according to the invention is preferably less than 10 ppm, more preferably less than 5 ppm and even more preferably less than 1 ppm.
  • a Ginkgo biloba extract according to the invention comprises from 20 to 30% by weight of flavone glycosides, from 2.5 to 4.5% by weight of glyglolides A, B, C and J (in total), from 2 to 4% by weight of bilobalide, less than 10% by weight of proanthocyanidines and less than 10 ppm of alkylphenol type compounds.
  • the Ginkgo biloba extract comprises from 22 to 26% by weight of flavone-glycosides, from 2.5 to 4.5% by weight of ginkgolides A, B, C and J (in total), of 2-4% by weight of bilobalide, less than 10% by weight of proanthocyanidines and less than 1 ppm of alkylphenol compounds.
  • Such an extract can be prepared according to the extraction methods as described in patent EP 431535.
  • the extract of Ginkgo biloba is the standardized extract EGb 761 ® as defined in particular in La Medical Press (K. Drieu, 31, September 25, 1986, supplement devoted to Ginkgo biloba extract, 1455-1457).
  • an extract as defined above contains less than 10-6 g of polycyclic aromatic hydrocarbons per kilogram (kg) of extract.
  • a Ginkgo biloba extract according to the invention comprises from 18 to 30% by weight of flavone-glycosides and from 34 to 46% by weight of terpene-lactones, and preferably from 20 to 28% by weight of flavone-glycosides and from 36 to 44% by weight of terpene-lactones.
  • a Ginkgo bi ⁇ oba extract according to the invention comprises about 52% by weight of flavone glycosides and about 13% by weight of terpene-lactones.
  • Such extracts may be prepared according to the extraction methods as described in patent EP 1379262.
  • a Ginkgo biloba extract according to the invention comprises from 28 to 35% by weight of flavone-glycosides and less than 1% of terpenes-lactones and, preferably, from 28 to 32% by weight of flavone- glycosides and less than 0.5% by weight of terpene-lactones.
  • Such extracts may be prepared according to the extraction methods as described in patent EP 822825.
  • the ginkgolide (s) may be replaced in whole or in part by their acetyl homologs, their alkoxylated counterparts or their glycosylated counterparts.
  • glycosylated homologs mention may be made of the compounds of general formula (I)
  • W, X, Y and Z independently represent the radicals H, OH, linear or branched alkoxy or OG s , G S -OH representing a mono- or a disaccharide, or a derivative or analog thereof, it being understood that the at least one of W, X, Y or Z represents a radical OG s .
  • compositions comprising a Ginkgo biloba extract may be in the form of solids, for example powders, granules, tablets, capsules, liposomes, suppositories or patch patches.
  • the Suitable solid carriers may be, for example, calcium phosphate, magnesium stearate, talc, sugars, lactose, dextrin, starch, gelatin, cellulose, methyl cellulose, carboxymethyl cellulose, and the like. sodium, polyvinylpyrrolidine and wax.
  • compositions comprising a Ginkgo biloba extract may also be in liquid form, for example, solutions, emulsions, suspensions or syrups.
  • suitable liquid carriers may be, for example, water, organic solvents such as glycerol or glycols, as well as their mixtures, in varying proportions, in water.
  • the administration of a drug according to the invention may be done topically, orally, parenterally, by injection (intramuscular, subcutaneous, intravenous, etc.).
  • the extract of Ginkgo biloba and in particular the standardized extract EGb 761 ® will be administered orally.
  • the daily administration dose of Ginkgo biloba extract considered will depend on the concentration of active ingredient extract and the severity of the mitochondrial disease to be treated.
  • the latter may be administered at a daily dose of between 100 and 500 mg / day, preferably between 120 and 480 mg / day and very preferably between 240 and 480 mg / day. /day.
  • Ginkgo biloba extract such as EGb 761 ® extract
  • mitochondrial encephalomyopathies such as Friedreich ataxia
  • the study may be a randomized, double-blind, double-arm, placebo-controlled phase II study in adult or male patients, men or women, 13 years of age and older with Friedreich ataxia.
  • the EGb 761 ® extract could be administered at a dose of 120 mg twice daily.
  • the imaging parameters will be monitored using P-31 NMR spectroscopy.
  • the clinical condition will be assessed by seeking improvement in Symptoms of the disease on the clinical scale (ICARS), psychometric tests such as the "9 hole Peg test” and the reaction time of patients to a light stimulus "choice reaction time test”.
  • ICARS clinical scale
  • psychometric tests such as the "9 hole Peg test”
  • reaction time of patients to a light stimulus “choice reaction time test”.
  • the criteria can be evaluated before and after 3 months of treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP07823343A 2006-07-27 2007-07-26 Verwendung eines gingko-biloba-extrakts zur behandlung von mitochondrienerkrankungen genetischen ursprungs Withdrawn EP2054069A2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0606862A FR2904222A1 (fr) 2006-07-27 2006-07-27 Utilisation d4extraits de ginkgo biloba pour le traitement de maladies mitochondriales
PCT/FR2007/001286 WO2008012439A2 (fr) 2006-07-27 2007-07-26 Utilisation d'un extrait de ginkso biloba pour le traitement de maladies mitochondriales d'origine génétique

Publications (1)

Publication Number Publication Date
EP2054069A2 true EP2054069A2 (de) 2009-05-06

Family

ID=37770716

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07823343A Withdrawn EP2054069A2 (de) 2006-07-27 2007-07-26 Verwendung eines gingko-biloba-extrakts zur behandlung von mitochondrienerkrankungen genetischen ursprungs

Country Status (4)

Country Link
US (1) US8097287B2 (de)
EP (1) EP2054069A2 (de)
FR (1) FR2904222A1 (de)
WO (1) WO2008012439A2 (de)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1011151A3 (fr) * 1997-05-13 1999-05-04 Jose Remacle Utilisation d'une composition pharmaceutique dans le traitement et/ou la prevention de l'ischemie.
JP2002517456A (ja) * 1998-06-11 2002-06-18 ソシエテ・ドゥ・コンセイユ・ドゥ・ルシェルシュ・エ・ダプリカーション・シャンティフィック・エス・ア・エス 虚血からのニューロンの保護
FR2782008B1 (fr) * 1998-08-07 2003-04-25 Sod Conseils Rech Applic Utilisation d'extraits de ginkgo biloba pour preparer un medicament destine a traiter la sclerose laterale amyotrophique
FR2823116B1 (fr) * 2001-04-10 2004-11-19 Sod Conseils Rech Applic Procede de preparation d'une extrait de feuilles de ginkgo biloba hautement enrichi en principes actifs
WO2003047511A2 (en) * 2001-11-29 2003-06-12 U.S. Department Of Veterans Affairs Use of gingko biloba extracts to promote neuroprotection and reduce weight loss
WO2005033093A1 (en) * 2003-09-19 2005-04-14 Galileo Pharmaceuticals, Inc. 7,8-bicycloalkyl-chroman derivatives

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2008012439A2 *

Also Published As

Publication number Publication date
US20090258095A1 (en) 2009-10-15
WO2008012439A3 (fr) 2008-04-17
FR2904222A1 (fr) 2008-02-01
US8097287B2 (en) 2012-01-17
WO2008012439A2 (fr) 2008-01-31

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