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WO2006134166A2 - Principe actif pharmaceutique pour franchir la barriere hemato-encephalique en liaison avec un principe actif acquis a partir d'un venin biogene, pour lutter contre des tumeurs au cerveau - Google Patents

Principe actif pharmaceutique pour franchir la barriere hemato-encephalique en liaison avec un principe actif acquis a partir d'un venin biogene, pour lutter contre des tumeurs au cerveau Download PDF

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Publication number
WO2006134166A2
WO2006134166A2 PCT/EP2006/063281 EP2006063281W WO2006134166A2 WO 2006134166 A2 WO2006134166 A2 WO 2006134166A2 EP 2006063281 W EP2006063281 W EP 2006063281W WO 2006134166 A2 WO2006134166 A2 WO 2006134166A2
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WIPO (PCT)
Prior art keywords
total
kda
poison
molecular weight
loxosceles
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
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PCT/EP2006/063281
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German (de)
English (en)
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WO2006134166A3 (fr
Inventor
Dirk Weickmann
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Toximed GmbH
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Toximed GmbH
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Publication of WO2006134166A2 publication Critical patent/WO2006134166A2/fr
Publication of WO2006134166A3 publication Critical patent/WO2006134166A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0004—Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood
    • 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

Definitions

  • composition for overcoming the blood-brain barrier in combination with a drug derived from biogenic toxins against brain tumors.
  • the composition and functioning of the blood-brain barrier are still only partially understood. This barrier plays a role in the protection of the brain from harmful substances, but also allows a regulated supply of energy.
  • Our body consists of individual organ systems and organs that require different but constant conditions for their function, for example, of nutrients, hormones or electrolytes. All organs are connected by the blood circulation. Since all components for the supply but also for the purification of the body are contained in the blood, filter systems must ensure that only the required substances are allowed through or partially retained for the individual organ systems.
  • the blood-tissue barrier also known as blood-parenchyma barrier, the blood-liver barrier, the blood-cerebro-barrier, the blood-brain barrier, the cerebro-cerebral barrier , the blood-nerve barrier, the blood-retinal barrier and the placental barrier.
  • the passage of certain substances from the bloodstream into the respective organ system is prevented or restricted by a so-called barrier effect if these organ systems do not require the constituents or only in a relatively low concentration.
  • carriers are not self-contained organs, but are formed from a multitude of cells and intercellular spaces that allow blood gases, nutrients and certain chemicals to pass through, or retain macromolecules as endothelial pores, and can not inhibit passage as lipid membranes in the vessel wall lipid-soluble substances or to exert a selective effect of active transport processes in the capillaries
  • the brain and the nerve tissue are protected by two filter systems, the blood-cerebro-spinal barrier and the blood-brain barrier.
  • glial cells Within the central nervous system, the spaces between the neurons are almost completely filled by glial cells and their foothills. The entire metabolism of nerve cells passes through these glial or endothelial cells. They are used for the installation of nerve cells and nerve fibers and for their nutrition and isolation.
  • One form of glial cells is the astrocytes. They have numerous processes with which they attach themselves to the wall of the capillaries and form a nearly columnless endothelial lining surrounding the capillaries on all sides.
  • endothelial cells are linked by "tight junctions" and selective selective permeability, which allows only particles smaller than 20 nm in diameter to pass through, so that all of the neuronal metabolism passes through this endothelial network, which is in the blood Gets substances like a biological filter if necessary, but keeps harmful substances away from the nervous system for brain function
  • This endothelial network and the endothelial cells that line the capillaries as a basal membrane are called the blood-brain barrier Unimpeded transmission of oxygen, carbon dioxide, D- Glucose, D - hexose, some L - amino acids and lipid - soluble substances that are necessary for the supply of the brain, as well as release products into the blood
  • the endproducts of the astrocytes provide a certain barrier for many substances like certain hormones, non - lipid soluble ones , water-soluble and chemical substances as well as proteins, thereby ensuring the maintenance of a constant environment for the neurons of the nervous system.
  • the cell structure of the astrocytes is arranged so that it forms an effective barrier to higher molecular substances and organisms. It is also not completely dense under normal conditions, so that some particles can always penetrate this barrier.
  • infections traumas, inflammations, intoxications, hypoxia, fever and in the area of tumors
  • the tight junctions between the endothelial cells are distended by the swelling of the astrocytes and are much more permeable to other substances.
  • the change in the width of the glade is due to swelling and swelling of the endothelial cells.
  • the basal membrane of the capillaries is not a closed layer. Depending on the density of the fiber network, pores develop in the membrane, which are actively involved in the mass transfer.
  • the permeability of the blood-brain barrier has been increased by artificial fever production similar to the process of infection and exploited for the treatment of central nervous system syphilis and psychiatric shock treatment by bringing drugs directly to the brain Has. After the end of the action of the conditions influencing the blood-brain barrier, the temporary permeability forms again.
  • Termozolomide (Temodal, registered), a lipophilic alkylans, is currently undergoing clinical research for the chemotherapy of patients with brain tumors of solid tumors. It overcomes the blood-brain barrier and increases the radiosensitivity of tumors in simultaneous radiotherapy.
  • tumors if reasonably achievable, are in principle cut out with the steel of a knife, burned by a wide range of irradiation, or destroyed by so-called chemotherapy with aggressive cytotoxic agents that attack even healthy cells.
  • Radiation is a spatial limitation of the surgical area is not possible. It will inevitably destroy healthy body cells. The unwanted
  • biogenic poisons began in the history of centuries already in the primeval times when they served to kill prey with poisoned weapons. For the safe use of these poisons, however, from the beginning certain basic knowledge about their treatment and effectiveness was required. The further attempts to decode the composition of the chemical structure of biogenic toxins later led to the targeted search for certain active substances as the actual cause of observed effects.
  • DE 19961 141 A1 discloses a pharmaceutical active substance in which it has been found that constituents of spider venoms from spiders of the family Sicaridae can be used for the treatment of tumor diseases.
  • a peptide toxin from the venom of this spider species another antagonistic substance obtained from the venom and / or a combination of these constituents are used medicinally in the main. It can be used for the treatment of tumor diseases as well as parallel or supportive to tumor operations and residual tumor tissue can be destroyed.
  • genetically modified body cells tumor cells
  • the total toxicity of this spider, so to speak, a cocktail of different substances, is lethal because of its even in small doses, not pharmaceutically usable.
  • this known active ingredient does not work in vivo in any combination in a facial tumor, in particular not in a particular type of brain tumor, namely an oligodendrocytoma.
  • the object of the active compound according to the invention while effectively overcoming the blood-brain barrier, to effect a complication-free killing of cancerous body cells from the area of the brain tissue, especially the rare brain tumor oligodendrocytoma, with an active ingredient obtained from biogenic poisons.
  • a solvent suitable for this purpose must also be indicated.
  • Latrodectus tredecimguttatus a) Latrodectus bishopi b) Latrodectus curacaviensis c) Latrodectus dahli d) Latrodectus erythromelas e) Latrodectus hasselti f) Latrodectus katipo g) Latrodectus menavodi h) Latrodectus rhodesiensis i) Latrodectus revivensis j) Latrodectus schuchi k) Latrodectus tredecimguttatus
  • the Black Widow as used in homeopathy, occurs mainly in America along the Pacific coast to Canada.
  • the homeopathic poison of the black widow is an important remedy for angina pectoris. This spider usually keeps away from human settlements and lives near the ground between stones and scrub. But where to find a spider are usually still several copies in the immediate vicinity.
  • Latrodectus bishopi occurs in central and southern Florida.
  • Latrodectus curacaviensis is native to the temperate zones of North and South America, as well as to the Netherlands Antilles.
  • the females are glossy black all over the body, only on the abdomen they have red to orange conspicuous drawings.
  • the legendary terrible poison is dangerous for a human being, but only in very rare cases fatal.
  • Latrodectus erythromelas is found in Sri Lanka.
  • Latrodectus hasselti is found from India to Australia and New Zealand and is often found in cellars, garages, sheds or outside WC houses. These spiders also like to live under stacks of wood and other building materials or even clutter.
  • Latrodectus katipo is New Zealand's only poisonous spider. It lives in most coastal areas of New Zealand, except in the extreme south. It is found near the ground in grasses and driftwood. The bite of Katipo can be deadly, but the antidote works within three days.
  • Latrodectus rhodesiensis is native to southern Africa.
  • Latrodectus schuchi (recently called Latrodectus lilianae) lives in Europe only in Spain, namely in Aragon.
  • Latrodectus tredezimguttatus is very common in southern Europe in cereal fields, especially in the Mediterranean, partly in Asia and Africa.
  • the appearance of this spider is characterized by 13 red spots on the abdomen in a completely shiny black body. Frequently one finds the irregularly built nets near the soil. There are always newer threads to the net it is very stable.
  • the center of the net forms an inverted shape with the shape of a basket and is usually found under an object such as a stone, a branch or in a wall crack.
  • Latrodectus variolus is found, for example, in America in Michigan. Female specimens have a red dot on the underside of their abdomen, males do not show it, but they wear yellow and red ribbons on their backs.
  • the active substance according to the invention is extracted from the total latrotoxin-free
  • Residual cocktail of the individual spiders obtained, wherein a Peptidtoxin - mixture with a molecular weight of 10 to 80 kDa and biogenic amines with a
  • the Latrodectus poison consists of 6 to 7 different proteins
  • Age of about 12 years can be used.
  • This solvent is composed of several components.
  • the preparation in 3 processing stages is described below:
  • Tarantula D4 is mixed in a homeopathic manner with shaking to the center of the earth with 15 ml of the 0.9% NaCl solution.
  • homeopathy the patient does not receive the drug in question in his mother tincture, but in a dilution stage.
  • the D-dilution steps are prepared by adding 1/10 of the stock solution to 9/10 alcohol and then shaking. This gives the first dilution of Dl of this dilution take again 1/10 and shake it with 9 parts of alcohol, and you get a D2. Thus, this procedure continues until finally high potencies, e.g. D 200 arise. Nevertheless, these are highly effective medicines. However, in order to search for an explanatory model, one has to say goodbye to physics, which works with simple linear substance-related theses.
  • Loxosceles are in the warmer up to the tropical areas of
  • North America, Central America, South America and the Caribbean represent about 50 species.
  • Loxosceles species bite only in strong physical contact. Especially in the living area, the bites are registered, which have a symptomatology similar to a mosquito bite. There is the concept of "necrotic arachndism”. This describes skin necrosis after bites of the Loxosceles species. Necroses are also known after bites from other spiders.
  • the Bulldog ants are ants belonging to the family of the Myrmicinae.
  • Ants on the earth can reach a length of up to 40 millimeters. They are diurnal and come in different sizes and colors.
  • the Bulldog ants have a long head, big eyes and strong jaws.
  • bulldog - ant Another type of bulldog - ant is small, black and moves forward jumping. This species creates jumps in a height up to 20 centimeters.
  • the special pharmaceutical active ingredient is then incorporated into the solvent thus obtained for the specific application in question.
  • the active ingredient according to the invention is incorporated to overcome the blood-brain barrier in this solvent to saturation.
  • the substances used according to the invention for the pharmaceutical active substance can be obtained in a natural way from spider animals of the genus Loxosceles. These poisons were originally used for prey and Predigestion of animal protein. This natural mode of action can be obtained by a preserving, gentle recovery of the poison base material (eg by manual milking).
  • a manual milking of the spiders is provided.
  • This real, genuine genuine poisons are obtained, in contrast, for example, in the electric milking, by electron flow restructured substances or molecules are obtained, which may be changed in their mode of action, or substances may be present in the poisons Otherwise the animal would not give up.
  • These substances may, but not necessarily, negatively impact the efficiency of the medically active compound contained in the poison cocktail.
  • an analysis and / or quality control of the crude toxin mixture can be carried out by electrophoretic methods.
  • the stimulation time did not last longer than 90 seconds, otherwise the animal would be exposed to unnecessary stress.
  • the syringe raised over the cannula.
  • the cannula was closed again with the needle protection cover.
  • the sealed syringe together with wounded poison was then directly spent in a desiccator. This was then stored for at least 12 hours in a freezer at least 14 degrees Celsius.
  • the scolopenders and scorpions were milked as described in the Melanoma patent (Clit. Patents "raum &zeit").
  • the needle protection cover was removed after removal from the freezer.
  • the cannula was dipped in solvent, eg, protein solvent (protein column chromatography solvent: 0.25 M Tris / HCl, pH 6.5 to 7.3, 1.92 M glycine, in distilled, deionized water) and raised to 1 ml. Due to denaturation, no SDS is used in the buffer. This gave poison in solution. Subsequently, the cannula was removed.
  • the individual poison solutions in syringes (5 pieces) thus prepared were collected by dislodging (spraying) in a sterile, clean Teflon vial at room temperature.
  • the sealed teflon vial was then shaken on a vortex without foaming for 30 seconds to give a homogeneous solution.
  • the entire solution was passed through a Plexiglas funnel (to avoid contamination) into a standing transparent Plexiglass column having an inner diameter of 1.5 cm, a wall thickness of 2 mm and a height of 50 cm and conical down to 1.5 mm, open, filled with 20 mL gel.
  • a Plexiglas funnel to avoid contamination
  • a standing transparent Plexiglass column having an inner diameter of 1.5 cm, a wall thickness of 2 mm and a height of 50 cm and conical down to 1.5 mm, open, filled with 20 mL gel.
  • the poison solution thus introduced passed through the gel, displacing the buffer in the gel.
  • Fractions of the same composition can be collected together.
  • the individual fractions were freeze-dried, for example, with the following parameters:
  • the fraction to be lyophilized was cooled to minus 22 degrees Celsius in an open teflon vial loosely covered with perforated aluminum foil. For safe freezing of the sample, a cooling time of 11 hours was observed. Then a vacuum of 0.200 mbar was applied. After reaching the vacuum, the fraction was heated to plus 4 degrees Celsius and maintained at this temperature for at least 24 hours while maintaining the vacuum. After freeze-drying, the teflon vial was screwed airtight with the lyophilized fraction. The storage time is approx. 6 months at room temperature, approx. 1 year at plus 7 degrees Celsius and approx. 15 years at minus 14 degrees Celsius.
  • Androctonus bicolor active substances from the venom of scorpions, namely the species Androctonus bicolor, are preferably used.
  • Androctonus bicolor is a subspecies of the numerous Androctonus species. They are also referred to as so-called Dickschwanzskorpione and are considered the most dangerous scorpions in the Middle East and North Africa. Androctonus bicolor occurs mainly in Morocco, eastern France, the highlands of Tunisia,
  • the mostly nachmode animals prefer as habitat the semi-deserts and the
  • Scorpions can reach the age of six to eight years. Most species grow very fast and can become sexually mature after six to eight months.
  • the peptide toxin can be obtained by fractionation methods known per se for the separation of proteins from the scorpion venom raw mixture (scorpion venom cocktail). It is preferred here that the peptide toxin is obtained by a column-chromatic purification method. In this case, all enzymes, biogenic amines, free amino acids and other low molecular weight molecules and / or drugs are removed.
  • the peptide toxin is present in such an amount as a pharmaceutically active substance that a tumor cell destructive effect of the active ingredient is achieved.
  • the required proportions are chosen so that the peptide toxin unfolds no or only a small toxic effect in the patient to be treated.
  • the amounts of pharmaceutical active ingredients on the type of tumor to be treated and the physical, and possibly psychological, circumstances of the respective patient to vote are to be made by a person skilled in the art on the basis of his technical knowledge and ability.
  • the pharmaceutical active ingredient according to the invention contains conventional carriers and excipients, such as antibiotics, antimycotics, antituberculosis, antiparasitic agents, cytostatic agents, amino acids, enzymes promoting wound healing and / or mitotic inhibitors.
  • antibiotics such as antibiotics, antimycotics, antituberculosis, antiparasitic agents, cytostatic agents, amino acids, enzymes promoting wound healing and / or mitotic inhibitors.
  • Penicillin / streptomycin, polymyxin / gentamycin (5%), mitopodocide, Vinca rosea alkaloids, bromelaina or bromelains are preferred here.
  • the present invention also encompasses derivatives and salts of the substances provided according to the invention.
  • the peptide toxin may contain one or more, substitutions and / or deletions of
  • Amino acids include, of course, it must be ensured that the inventive medical effect is maintained.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Hematology (AREA)
  • Botany (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne un principe actif pharmaceutique et un procédé pour le préparer, pour réaliser le franchissement fonctionnel de la barrière hémato-encéphalique dans le but d'effectuer un traitement plus poussé d'une tumeur au cerveau, le principe actif comprenant une quantité active d'un point de vue pharmaceutique de: a) le cocktail de venin résiduel global libéré par une latrotoxine, issu du venin de certaines araignées du type Latrodectus. Selon l'invention, b) un mélange de toxines peptidiques ayant un poids moléculaire de 10 kDa à 80 kDa, et c) des amines biogènes ayant un poids moléculaire de 500 Da à 3000 Da sont utilisés. Ce principe actif est incorporé à un solvant qui est produit de la manière suivante: d) comme composante de base sont incorporés 7 ml de la substance homéopathique Tarantula D4, dans 15 ml de solution de NaCl à 0,9 %; e) à la substance de base est ajouté jusqu'à 0,5 ml d'une solution saturée du cocktail de venin global d'araignées des types Loxosceles laeta, Loxosceles gaucho, Loxosceles Mallorca, ou Loxosceles Menorca; f) en fonction des rapports de quantité nécessaire, le cocktail de venin global est broyé dans de l'acide formique sans eau auquel sont à nouveau ajoutés 1 à 2 ml de l'extrait global de venins des fourmis bouledogue, cette quantité se référant à une quantité du cocktail de venin global de 10 ml. Le principe actif destiné à traiter des tumeurs dans la zone cérébrale, en une quantité acceptable d'un point de vue pharmaceutique, comprend les composantes suivantes: g) une combinaison peptide global-toxine issue du venin de scorpions de l'espèce Androctonus bicolor, un procédé de purification permettant l'élimination de toutes les molécules à bas poids moléculaires et/ou principes actifs; et h) le poids moléculaire du principe actif prend des valeurs définies.
PCT/EP2006/063281 2005-06-15 2006-06-16 Principe actif pharmaceutique pour franchir la barriere hemato-encephalique en liaison avec un principe actif acquis a partir d'un venin biogene, pour lutter contre des tumeurs au cerveau Ceased WO2006134166A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005027665.2 2005-06-15
DE200510027665 DE102005027665A1 (de) 2005-06-15 2005-06-15 Pharmazeutischer Wirkstoff zur Überwindung der Blut-Hirn-Schranke in Verbindung mit einem aus biogenen Giften gewonnenen Wirkstoff gegen Hirntumore

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WO2006134166A2 true WO2006134166A2 (fr) 2006-12-21
WO2006134166A3 WO2006134166A3 (fr) 2007-03-08

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110038846A1 (en) * 2006-12-20 2011-02-17 Dirk Weickmann Pharmaceutical composition, use of the pharmaceutical composition for treating a brain tumor, production process thereof and a kit of parts comprising the pharmaceutical composition

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DD35618A (fr) *
DE10324062A1 (de) * 2003-05-27 2004-12-16 Toximed Gmbh Pharmazeutischer Wirkstoff

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110038846A1 (en) * 2006-12-20 2011-02-17 Dirk Weickmann Pharmaceutical composition, use of the pharmaceutical composition for treating a brain tumor, production process thereof and a kit of parts comprising the pharmaceutical composition
US8367119B2 (en) * 2006-12-20 2013-02-05 Abitec Angewandte Bio-Technologie Gbr Pharmaceutical composition, use of the pharmaceutical composition for treating a brain tumor, production process thereof and a kit of parts comprising the pharmaceutical composition

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Publication number Publication date
WO2006134166A3 (fr) 2007-03-08
DE102005027665A1 (de) 2006-12-21

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