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Pharmaceutical Composition Comprising Factor VII Polypeptides and TAFI Polypeptides

a technology of factor vii and polypeptides, which is applied in the direction of drug compositions, peptide/protein ingredients, extracellular fluid disorder, etc., can solve the problems of complex structure, high cost, and high risk of human virus transmission, and achieve the effects of improving coagulation, reliable and widely applicable, and enhancing or ensuring formation of stable haemostatic plugs

Inactive Publication Date: 2008-03-20
NOVO NORDISK HEALTH CARE AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides pharmaceutical compositions and methods for treating bleeding episodes and coagulation disorders. The compositions comprise factor VII or a factor VII-related polypeptide and TAFI or a TAFI-related polypeptide in single-unit dosage forms, which can be used in combination to effectively treat bleeding events. The compositions exhibit synergistic effects and no substantial side effects, such as systemic activation of the coagulation system. The methods for treating bleeding episodes involve administering the factor VII and TAFI preparations to a subject in need thereof. The invention also provides a kit for treating bleeding episodes.

Problems solved by technology

However, also moderate bleedings requiring the administration of human blood or blood products (latelets, leukocytes, plasma-derived concentrates for the treatment of coagulation defects, etc.) may lead to complications associated with the risk of transferring human viruses (hepatitis, HIV, parvovirus, and other, by now unknown viruses).
Extensive bleedings requiring massive blood transfusions may lead to the development of multiple organ failure including impaired lung and kidney function.
Once a subject has developed these serious complications a cascade of events involving a number of cytokines and inflammatory reactions is started making any treatment extremely difficult and unfortunately often unsuccessful.

Method used

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  • Pharmaceutical Composition Comprising Factor VII Polypeptides and TAFI Polypeptides
  • Pharmaceutical Composition Comprising Factor VII Polypeptides and TAFI Polypeptides
  • Pharmaceutical Composition Comprising Factor VII Polypeptides and TAFI Polypeptides

Examples

Experimental program
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Effect test

example 1

Improving Haemostatic Clot Stability by Combining Coagulation Factors Vlla and TAFI

Methods:

[0205] Clot lysis assay: Normal human plasma diluted 10-fold with buffer (20 mM HEPES, 150 mM NaCl, 5 mM CaCl, pH 7.4) containing Innovin (Dade Behring, 2000-fold dilution), rFVIIa (Novo Nordisk A / S, Bagsvaerd, Denmark; various concentrations) and t-PA (American Diagnostics, 8 nM) was added to 96-well ELISA plates and turbidity at 650 nm was measured over time at room temperature. Where indicated, purified human TAFI (Bajzar et al., J. Bioac Chem. 270:14477, 1995, various concentrations) was included.

[0206] Rotatonal thromboelastography (roTEG): Measurements was conducted on citrated normal human plasma added 5 nM t-PA and the effect of addition of 1 nM FVIIa alone or in combination with 30 nM TAFI was analyzed. Clotting was initiated by addition of Innovin (final concentration 2000-fold diluted, Dade Behring #526945) and calcium (final concentration 15 mM) in a 20 mM HEPES, 150 mM NaCl, ...

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Abstract

The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide, and TAFI or a TAFI-related polypeptide, and the use thereof for treating bleeding episodes.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application is a Divisional of copending U.S. application Ser. No. 10 / 290,814 filed Nov. 8, 2002 notice of Allowance mailed Jun. 29, 2007). This patent application claims the benefit of U.S. Provisional Patent Application No. 60 / 333,672 filed Nov. 27, 2001 and Danish Patent Application No. PA 2001 01664, filed Nov. 9, 2001.FIELD OF THIS INVENTION [0002] The present invention relates to a pharmaceutical composition comprising factor VII or a factor VII-related polyp eptide and TAFI or a TAFI-related polyp eptide. The invention also relates to the use of a combination of a factor VII or a factor VII-related polyp eptide and a TAFI or a TAFI-related polyp eptide for the manufacture of a medicament for treatment of subjects suffering from bleeding episodes, or prevention hereof. The invention also relates to a method for treatment of bleeding episodes in subjects and to a method for enhancing clot formation in a subject. The pre...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/48A61P7/00A61P7/04
CPCA61K38/484A61K38/4846A61K2300/00A61P7/00A61P7/04
Inventor ROJKJAER, RASMUS
Owner NOVO NORDISK HEALTH CARE AG
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