Treatment of severe community-acquired pneumonia by administration of tissue factor pathway inhibitor (tfpi)

A technology for severe pneumonia and preparations, which can be used in drug combinations, medical preparations containing active ingredients, peptide/protein ingredients, etc., and can solve problems such as reducing the mortality rate of sepsis

Inactive Publication Date: 2009-05-06
CHIRON CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Several clinical trials conducted mainly in meningococcal endotoxemia, which is characterized by fulminant DIC, have failed to demonstrate that heparin therapy reduces sepsis mortality

Method used

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  • Treatment of severe community-acquired pneumonia by administration of tissue factor pathway inhibitor (tfpi)
  • Treatment of severe community-acquired pneumonia by administration of tissue factor pathway inhibitor (tfpi)
  • Treatment of severe community-acquired pneumonia by administration of tissue factor pathway inhibitor (tfpi)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] ala-TFPI therapy in patients with severe pneumonia

[0088] Patients with severe pneumonia were evaluated to study the possible effect of ala-TFPI treatment on a relatively homogeneous group of patients. Patients with pneumonia were identified if the investigator demonstrated that one of the sources of sepsis was pneumonia. Other sites of infection may also be present. Aspiration pneumonia (patient) was excluded due to the difficulty in distinguishing infections due to chemical sequelae. Identified pneumonia patients were then classified as culture-positive (either evidence of infection, such as cultures or Gram strains (positive)) or culture-negative (negative cultures or no cultures). The patient was treated by continuous intravenous infusion at a dose of 0.025 mg / kg / hour with a non-glycosylated ala-TFPI preparation expressed in Escherichia coli containing 300 mM L-arginine, 20 mM sodium citrate, pH 5 .5. Prepare buffer solution with osmolality of 560+ / -110mOsm. T...

Embodiment 3

[0101] Analysis of confirmed infection types in patients with severe pneumonia

[0102] As noted above, the overall benefit of ala-TFPI treatment was observed in patients with the most established infection, ie, those with positive blood cultures. Analyzing severe pneumonia patients with confirmed infection types, ala-TFPI treatment efficacy was observed in subjects with positive blood cultures and other evidence (Table 6). Its effect was strongest in the bacteremia group, that is, the group with the highest probability of infection or the most obvious source of infection.

[0103] Table 6. Mortality by (different) culture status and pneumonia status

[0104]

[0105]

[0106] As shown above, patients with proven infection (blood + "other" evidence) benefited from TFPI treatment when heparin was not used. Drug efficacy in the pneumonia group most likely contributed to this result (Table 7). This finding seems to indicate that the benefit of endogenous anticoagulants i...

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Abstract

Methods for prophylactically or therapeutically treating severe pneumonia involve administration of tissue factor pathway inhibitor (TFPI) or a TFPI analog to patients suffering from or at risk of developing this condition. The methods involve the use of continuous intravenous infusion of TFPI or a TFPI analog, preferably at low doses to avoid adverse side effects.

Description

field of invention [0001] The present invention relates to a method for therapeutically treating severe community-acquired pneumonia. More specifically, the invention relates to the administration of tissue factor pathway inhibitor proteins to alleviate overexpansion of physiological pathways associated with severe pneumonia. Background of the invention [0002] Acute infection of one or more functional elements of the lung, including the alveolar spaces and interstitium, can lead to pneumonia. About 2 million people in the United States contract pneumonia each year, and 40,000-70,000 die. Pneumonia ranks sixth among all causes of death, and it is the most common fatal nosocomial (hospital-acquired) infection. In the United States, community-acquired pneumonia (CAP) has a significant impact on health care funding, with an estimated annual direct cost of $14 billion and lost wages of $9 billion (Lynch J P, Martinez F J., "Community-acquired pneumonia" (Community- acquired ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/57A61P11/00
CPCA61K38/57A61K38/00A61P11/00A61P11/16A61K38/17
Inventor A·克里西
Owner CHIRON CORP
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