Pharmaceutical composition comprising factor vii polypeptides and factor v polypeptides

A composition and factor technology, which can be used in drug combinations, pharmaceutical formulations, peptide/protein components, etc., and can solve problems such as refractory treatment

Inactive Publication Date: 2005-03-16
NOVO NORDISK AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Once a subject has developed these serious complications, a cascade of events involving many cytokines and inflammatory responses begins, making any treatment extremely difficult and often woefully unsuccessful

Method used

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  • Pharmaceutical composition comprising factor vii polypeptides and factor v polypeptides

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Experimental program
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Effect test

preparation example Construction

[0164] Compound preparation:

[0165] Preferably prepared by recombinant DNA techniques such as those described by Hagen et al. in Proc. Purified human Factor Vila suitable for use in the present invention.

[0166] Also by Broze and Majerus, J. Biol. Chem. 255(4): 1242-1247, 1980 and Hedner and Kisiel, J. Clin. Invest., 71 : 1836-1841, Factor VII is produced by the method described in 1983. These methods yield Factor VII without detectable amounts of other coagulation factors. Even further purified Factor VII preparations can be obtained by including additional gel filtration as a final purification step. Factor VII is then converted into activated Factor Vila by known means, for example using several different plasma proteins, such as Factor Via, IXa or Xa. On the other hand, as described by Bjoern et al. (Research Disclosure (Research Disclosure), 269, September 1986, pp. 564-565), by passing Factor VII through an ion exchange column, such as MonoQ  (Pharmacia Fine Ch...

Embodiment 1

[0217] method:

[0218] Clot assay: Aliquots (55 μl) of rFVIIa (1 μg / ml) dissolved in 50 mM Pipes, 100 mM NaCl, 2 mM EDTA, 1% BSA, pH 7.2 were mixed with 100 μM PC / PS carrier in the same buffer and 50mM CaCl 2 A 55 μl aliquot of the solution was incubated for 5 min. A 55 [mu]l aliquot of normal human plasma (NHP) or factor VIII deficient plasma (FVIII-DP) was then added and coagulation was followed for 400 seconds in the ACL coagulator using the standard APTT program. Where indicated, factor V (30 nM) was included.

[0219] result:

[0220] Clot test: NHP and FVIII-DP did not clot during the 400 s monitoring period before addition of Factor Vila or Factor V. Addition of Factor VIIa (1 μg / ml) reduced the clotting time of NHP to 184.0±1.1 s and that of FVIII-DP to 126.6±3.1 s ( figure 1 ). Addition of both Factor Vila (1 μg / ml) and Factor V (30 nM) reduced the clotting times of NHP and FVIII-DP to 116.2±0.8 seconds and 109.8±1.41 seconds, respectively ( figure 1 ).

[02...

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Abstract

The present invention relates to a composition comprising factor VII or a factor VII-related polypeptide, and factor V or a factor V-related polypeptide, and the use thereof for treating bleeding episodes, such as for reducing clotting time, enhancing haemostasis or increasing the clot strength.

Description

field of invention [0001] The present invention relates to compositions comprising Factor VII or Factor VII-related polypeptides and Factor V or Factor V-related polypeptides. The present invention also relates to the use of a combination of Factor VII or Factor VII-related polypeptides and Factor V or Factor V-related polypeptides in the manufacture of a medicament for treating or preventing bleeding episodes in subjects suffering from bleeding episodes. The invention also relates to methods of treating bleeding episodes in a subject, and to methods of enhancing clot formation in a subject. The invention also relates to kits containing these compounds. Background of the invention [0002] Hemostasis is initiated by the formation of a complex between tissue factor (TF), which is exposed to circulating blood as a result of vessel wall damage, and FVIIa, which is present in circulation in an amount corresponding to about 1% of the total FVII protein amount. This complex anch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/00A61K38/36A61K38/48C12N15/09A61P7/04A61P9/00
CPCA61K38/482A61K38/4846A61K38/36A61P7/04A61P9/00A61K2300/00
Inventor R·罗基克杰尔
Owner NOVO NORDISK AS
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