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Dalbavancin compositions for treatment of bacterial infections

一种达巴万星、组合物的技术，应用在达巴万星组合物领域，能够解决分子没有被表征等问题

Active Publication Date: 2012-07-04
VICURON PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The process for preparing certain dalbavancin components reported in the '509 patent also produced small amounts of dalbavancin N 15 , N 15 -dialkyl analogues, but these molecules were not characterized

Method used

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  • Dalbavancin compositions for treatment of bacterial infections
  • Dalbavancin compositions for treatment of bacterial infections
  • Dalbavancin compositions for treatment of bacterial infections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0451] Example 1. Efficacy and Safety of Weekly Dalbavancin in Deep Skin and Soft Tissue Infections

[0452] This randomized, controlled study evaluated the safety and efficacy of two dalbavancin dosing regimens. Adult patients with skin and soft tissue infections (SSTIs) involving deep skin structures or requiring surgical intervention were randomized into three groups: study group 1: received dalbavancin 1100 mg intravenously (IV) on day 1; group 2 Study group: received 1 g dalbavancin IV on day 1 and 500 mg dalbavancin IV on day 8; study group 3: received "standard of care". Clinical and microbiological responses and adverse events were evaluated.

[0453] population for analysis

[0454] Sixty-two patients were randomized into the study; all patients received at least one dose of study drug. Safety and efficacy were assessed in 4 study populations and defined as follows: The intent-to-treat (ITT) population included all patients (all randomized subjects) who received ...

Embodiment 2

[0503] Example 2. Efficacy and Safety of Weekly Dalbavancin in the Treatment of Catheter-Related Bloodstream Infections (CR-BSI)

[0504] The study evaluated the efficacy of a once-weekly dalbavancin dosing regimen compared with standard-of-care vancomycin in the treatment of catheter-related bloodstream infection (CR-BSI) in adults due to Gram-positive bacterial pathogens efficacy and safety.

[0505] method

[0506] In this open-label, comparative, multicenter study, patients meeting inclusion / exclusion criteria with CR-BSI due to suspected or known Gram-positive pathogens were randomized into one of two treatment groups. In the weekly dalbavancin regimen, dalbavancin was administered once a week, and in the vancomycin regimen, the comparator (vancomycin) was administered daily. Catheter removal was required in patients with S. aureus infection; it was up to the investigator to decide whether to dispose of the catheter in patients with coagulase-negative staphylococcus (...

Embodiment 3

[0526] Example 3. Dalbavancin Pharmacokinetics and Renal Excretion in Healthy Subjects

[0527] The primary objective of this study was to characterize the pharmacokinetics of dalbavancin and to calculate the extent of renal excretion in healthy subjects receiving therapeutic doses of the drug. This is an open-label, non-comparative study.

[0528] study drug treatment

[0529] A single 1000 mg IV dose of dalbavancin was infused over 30 minutes into healthy male or female subjects between the ages of 18 and 65.

[0530] Six subjects (1 female and 5 males) were enrolled, received study drug and completed all aspects of the study. Three subjects were Caucasian and three subjects were African American. The mean age was 29.8 years (range 22 to 63). The average height was 68.6 inches (range 62 inches to 75 inches) and the average weight was 179.6 pounds (range 140 pounds to 244 pounds).

[0531] Pharmacokinetics

[0532] Blood and urine were collected on study days 1, 2, ...

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PUM

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Abstract

The invention provides methods and compositions for treatment of bacterial infections. The composition may be a combination of factors, which include A0, A1, B1, B2, CO, C1, isoB0, and MAG, in the presence of low level solvent. Methods of the invention include administration of dalbavancin formulations for treatment of abacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimens include multiple dose administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection. Dosing regimens for renal patients are also included.

Description

field of invention [0001] The present application relates to dalbavancin compositions and methods of using the compositions in methods of treating bacterial infections. [0002] Cross References to Related Applications [0003] This application is based on U.S. Application Serial No. [Attorney Docket No. 892,280-225], filed April 26, 2005, which is U.S. Application Serial No. 10 / 834,395, filed April 27, 2004 continuation-in-part of U.S. Application Serial No. 10 / 714,261 filed November 14, 2003, which requests the benefit of 60 / 427,654 U.S. Provisional Patent Applications 60 / 485,694, filed August 8, 60 / 495,048, filed August 13, 2003, and 60 / 496,483, filed August 19, 2003, the disclosure of all of which The contents of which are incorporated herein by reference in their entirety. Background of the invention [0004] Hospital-acquired bloodstream infections are the leading cause of death in the United States, according to the U.S. Center for Disease Control and Prevention. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/16C07K9/00A61K31/704A61K38/12A61K38/14
CPCC07K9/008A61K38/14A61K38/12A61K31/704A61K38/00A61K47/00A61P11/00A61P13/12A61P17/00A61P17/02A61P19/02A61P29/00A61P31/04A61P31/10A61P7/00A61P9/00A61K2300/00
Inventor M·斯托格尼沃L·克罗姆伯R·茨亚巴逖
Owner VICURON PHARMA INC
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