Abstract

It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

IPC Classes  ?

• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
• C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Abstract

The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

IPC Classes  ?

• G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing

Goods & Services

Pharmaceutical preparations for the treatment and prevention of bone diseases and pathologies related to the medulla ossium transplantation; Veterinary preparations for the treatment and prevention of bone diseases and pathologies related to the medulla ossium transplantation

Abstract

In various embodiments, the present disclosure teaches methods of treating patients diagnosed as having sinusoidal obstruction syndrome with defibrotide.

IPC Classes  ?

• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• A61P 1/16 - Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• A61K 9/00 - Medicinal preparations characterised by special physical form

Abstract

It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

IPC Classes  ?

• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• C12N 9/68 - Plasmin, i.e. fibrinolysin
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• A61K 38/36 - Blood coagulation or fibrinolysis factors
• C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
• C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Abstract

It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

IPC Classes  ?

• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• C12N 9/68 - Plasmin, i.e. fibrinolysin
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• A61K 38/36 - Blood coagulation or fibrinolysis factors
• C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
• C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Abstract

It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.

IPC Classes  ?

• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• C12N 9/68 - Plasmin, i.e. fibrinolysin
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• A61K 38/36 - Blood coagulation or fibrinolysis factors
• C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
• C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Abstract

In various embodiments, the present disclosure teaches methods of treating patients diagnosed as having sinusoidal obstruction syndrome with defibrotide or preventing the development of sinusoidal obstruction syndrome in a patient by prophylactically administering defibrotide to an at-risk patient.

IPC Classes  ?

• A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
• A61P 1/16 - Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics

Goods & Services

Providing medical information relating to the treatment and prevention of bone diseases; providing medical information relating to the treatment and prevention of pathologies related to the medulla ossium transplantation.

Goods & Services

Providing medical information relating to the treatment and prevention of bone diseases; providing medical information relating to the treatment and prevention of pathologies related to the medulla ossium transplantation.

Abstract

The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

IPC Classes  ?

• G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing

Goods & Services

(1) Providing medical information relating to the treatment and prevention of bone diseases; providing medical information relating to the treatment and prevention of pathologies related to the medulla ossium transplantation

Goods & Services

Providing medical information relating to the treatment and prevention of bone diseases; providing medical information relating to the treatment and prevention of pathologies related to the medulla ossium transplantation

Abstract

Defibrotide for use in prophylaxis and/or treatment of Graft versus Host Disease (GVHD) in humans is disclosed, preferably in hematopoietic stem cell transplantation (HSCT), more preferably allogeneic hematopoietic stem cell transplantation. Graft versus Host Disease of the invention (GVHD) can be acute aGVHD and/or chronic cGVHD, preferably acute.

IPC Classes  ?

• A61K 31/70 - CarbohydratesSugarsDerivatives thereof
• C07H 21/02 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
• C07H 21/04 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
• A61K 9/00 - Medicinal preparations characterised by special physical form
• A61K 9/08 - Solutions
• C12N 5/00 - Undifferentiated human, animal or plant cells, e.g. cell linesTissuesCultivation or maintenance thereofCulture media therefor

Goods & Services

Pharmaceutical products, namely, pharmaceutical preparations for the treatment and prevention of bone diseases; pharmaceutical products for the treatment and prevention of pathologies related to the medulla ossium transplantation.

Goods & Services

Pharmaceutical products, namely, pharmaceutical preparations for the treatment and prevention of bone diseases; pharmaceutical products for the treatment and prevention of pathologies related to the medulla ossium transplantation.

Goods & Services

(1) Pharmaceutical products, namely, pharmaceutical preparations for the treatment and prevention of bone diseases; pharmaceutical preparations for the treatment and prevention of pathologies in the field of the medulla ossium transplantation

Abstract

The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

IPC Classes  ?

• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Abstract

The present invention relates to cell-based methods for determining the biological activity of defibrotide. In particular, the invention provides a method for assessing the potency of defibrotide by assessing the viability of mammalian cells in the presence of at least one cytotoxic agent and one or more concentrations of defibrotide. Such methods are particularly useful for standardizing pharmaceutical compositions comprising defibrotide.

IPC Classes  ?

• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Goods & Services

Pharmaceutical products, namely, pharmaceutical preparations for the treatment and prevention of bone diseases; pharmaceutical products for the treatment and prevention of pathologies related to the medulla ossium transplantation

Abstract

Defibrotide for use in prophylaxis and/or treatment of Graft versus Host Disease (GVHD) in humans is disclosed, preferably in hematopoietic stem cell transplantation (HSCT), more preferably allogeneic hematopoietic stem cell transplantation. Graft versus Host Disease of the invention (GVHD) can be acute aGVHD and/or chronic cGVHD, preferably acute.

IPC Classes  ?

• C07H 21/02 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
• C07H 21/04 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
• A61K 31/70 - CarbohydratesSugarsDerivatives thereof
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• A61K 31/7088 - Compounds having three or more nucleosides or nucleotides

Abstract

It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg.

IPC Classes  ?

• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• C12N 9/68 - Plasmin, i.e. fibrinolysin
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• A61K 38/36 - Blood coagulation or fibrinolysis factors
• C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
• C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

Abstract

It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg.

IPC Classes  ?

• C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
• C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers

Abstract

Defibrotide for use in prophylaxis and/or treatment of Graft versus Host Disease (GVHD) in humans is disclosed, preferably in hematopoietic stem cell transplantation (HSCT), more preferably allogeneic hematopoietic stem cell transplantation. Graft versus Host Disease of the invention (GVHD) can be acute aGVHD and/or chronic cGVHD, preferably acute.

IPC Classes  ?

• C07H 21/02 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
• C07H 21/04 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
• A61K 31/70 - CarbohydratesSugarsDerivatives thereof
• A61K 31/711 - Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
• C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids

Abstract

Defibrotide for use in prophylaxis and/or treatment of Graft versus Host Disease (GVHD) in humans is disclosed, preferably in hematopoietic stem cell transplantation (HSCT), more preferably allogeneic hematopoietic stem cell transplantation. Graft versus Host Disease of the invention (GVHD) can be acute aGVHD and/or chronic cGVHD, preferably acute.

IPC Classes  ?

• A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
• A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
• A61P 43/00 - Drugs for specific purposes, not provided for in groups

Goods & Services

Pharmaceutical products, pharmaceutical products for the treatment of pathologies related to the medulla ossium transplantation.

Goods & Services

(1) Pharmaceutical preparations for the treatment and prevention of bone diseases; pharmaceutical preparations for the treatment and prevention of pathologies related to the medulla ossium transplantation.

Goods & Services

Pharmaceutical products, namely, pharmaceutical preparations for the treatment and prevention of bone diseases; pharmaceutical products for the treatment and prevention of pathologies related to the medulla ossium transplantation

Goods & Services

Pharmaceutical products,Pharmaceutical products for the treatment of pathologies relating to bone marrow transplantation.

Goods & Services

Pharmaceutical and veterinary preparations.

Goods & Services

Pharmaceutical and veterinary preparations.

Abstract

A composition of phosphodiester oligonucleotides of various defined sizes has been created that mimics the effects of defibrotide. The composition essentially consists of mixtures of synthetic phosphodiester oligonucleotides comprising Nmers ranging from 40 mers to 65 mers. The phosphodiester oligonucleotides are preferably heteropolymers composed of either A, G, C, and T at each position but may also be homopolymers, i.e. the same base may be present at each position in the oligonucleotide. These mixtures are effective in the treatment of cancer and other diseases.

IPC Classes  ?

• C12N 15/11 - DNA or RNA fragmentsModified forms thereof
• A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
• A61K 48/00 - Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseasesGene therapy
• A61P 9/00 - Drugs for disorders of the cardiovascular system
• A61P 35/00 - Antineoplastic agents
• C12N 5/02 - Propagation of single cells or cells in suspensionMaintenance thereofCulture media therefor

Goods & Services

Chemicals used in industry, science, photography as well as in agriculture, horticulture and silviculture; unprocessed artificial resins, unprocessed plastics; soil fertilisers; fire extinguishing compositions; metal tempering and soldering preparations; chemical substances for preserving foodstuffs; tanning substances; adhesives used in industry. Bleaching preparations and other substances for laundry use; cleaning, polishing, scouring and abrasive preparations; soaps; perfumery, essential oils, cosmetics, hair lotions; dentifrices. Pharmaceutical, veterinary and hygienic products; dietetic substances for medical use, food for babies; plasters, materials for dressings; material for stopping teeth and dental wax; disinfectants; preparations for destroying vermin; fungicides, herbicides.

Goods & Services

Produits chimiques pour l'industrie. Produits pharmaceutiques, produits chimico-pharmaceutiques, produits chimiques à usage pharmaceutique.