Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-09-14
2002-01-22
Spivack, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06340689
ABSTRACT:
BACKGROUND OF THE INVENTION
Quinolones have been shown to be effective to varying degrees against a range of certain respiratory tract pathogens. However, as diseases caused by these pathogens are on the rise, there exists a need for antimicrobial compounds that are more potent and that exhibit a longer post-antibiotic effect than the present group of quinolones.
Gemifloxacin mesylate (SB-265805) is a novel fluoroquinolone useful as a potent antibacterial agent. Gemifloxacin compounds are described in detail in patent application PCT/KR98/00051 published as WO 98/42705. Patent application EP 688772 discloses novel quinoline(naphthyridine)carboxylic acid derivatives, including anhydrous (R,S)-7-(3-aminomethyl-4-methoxyiminopyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid of formula I.
PCT/KR98/00051 discloses (R,S)-7-(3-aminomethyl-4-syn-methoxyiminopyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid methanesulfonate and hydrates thereof including the sesquihydrate.
Provided herein is an invention based, in part, on a significant discovery made using a gemifloxacin compound against a range of variety of Legionella isolated from nosocomial or acquired respiratory tract infections and from environmental sources, demonstrating the activity of the gemifloxacin compound used was superior to a number of quinolones as described in more detail herein. Gemifloxacin compounds are valuable compounds for the treatment of diseases caused by or related to atypical respiratory tract pathogens, thereby filling an unmet medical need.
SUMMARY OF THE INVENTION
An object of the invention is a method for modulating metabolism of atypical upper respiratory pathogenic bacteria comprising the step of contacting atypical upper respiratory pathogenic bacteria with an antibacterially effective amount of a composition comprising a gemifloxacin compound, or an antibacterially effective derivative thereof.
A further object of the invention is a method wherein said atypical upper respiratory pathogenic bacteria is selected from the group consisting of: a member of the genus Legionella, a member of the genus, Pseudomonas,
Pseudomonas aeruginosa
strain, a
Legionella pneumophila
strain, a
Legionella pneumophila
serogroup 1, a
Legionella pneumophila
serogroup 2, a
Legionella pneumophila
serogroup 3, a
Legionella pneumophila
serogroup 4, a
Legionella pneumophila
serogroup 5, a
Legionella pneumophila
serogroup 6, a
Legionella pneumophila
serogroup 7, a
Legionella pneumophila
serogroup 8, a
Legionella dumoffli
strain, a
Legionella longbeacheae
strain, a
Legionella micdadei
strain, a
Legionella oakridgensis
strain, a
Legionella feelei
strain, a
Legionella anisa
strain, a
Legionella sainthelensi
strain, a
Legionella bozemanii
strain, a
Legionella gormanii
strain, a
Legionella wadsworthii
strain, a
Legionella jordanis
strain and a
Legionella gormanii
strain.
Also provided by the invention is a method of treating or preventing a bacterial infection by atypical upper respiratory pathogenic bacteria comprising the step of administering an antibacterially effective amount of a composition comprising a gemifloxacin compound to a mammal suspected of having or being at risk of having an infection with atypical upper respiratory pathogenic bacteria.
A preferred method is provided wherein said modulating metabolism is inhibiting growth of said bacteria or killing said bacteria.
A further preferred method is provided wherein said contacting said bacteria comprises the further step of introducing said composition into a mammal, particularly a human.
Further preferred methods are provided by the invention wherein said bacteria is selected from the group consisting of: a member of the genus Legionella, a member of the genus, Pseudomonas,
Pseudomonas aeruginosa
strain, a
L. pneumophila
strain, a
L. pneumophila
serogroup 1, a
L. pneumophila serogroup
2, a
L. pneumophila
serogroup 3, a
L. pneumophila serogroup
4, a
L. pneumophila serogroup
5, a
L. pneumophila
serogroup 6, a
L. pneumophila
serogroup 7, a
L. pneumophila
serogroup 8, a
L. dumoffii
strain, a
L. longbeacheae
strain, a
L. micdadei
strain, a
L. oakridgensis
strain, a
L. feelei
strain, a
L. anisa
strain, a
L. sainthelensi
strain, a
L. bozemanii
strain, a
L. gormanii
strain, a
L. wadsworthii
strain, a
L. jordanis
strain and a
L. gormanii
strain.
A further embodiment of the invention is method for modulating metabolism of atypical upper respiratory pathogenic bacteria comprising the step of contacting atypical upper respiratory pathogenic bacteria with an antibacterially effective amount of a composition comprising a compound selected from the group consisting of: gemifloxacin, ofloxacin, levofloxacin, trovafloxacin, azithromycin, moxifloxacin, ciprofloxacin, clarithromycin, rifampicin and erythromycin; or an antibacterially effective derivative of any of these compounds.
A still further embodiment of the invention is a method of treating or preventing a bacterial infection by atypical upper respiratory pathogenic bacteria comprising the step of administering an antibacterially effective amount of a composition comprising a compound selected from the group consisting of: gemifloxacin, ofloxacin, levofloxacin, trovafloxacin, azithromycin, moxifloxacin, ciprofloxacin, clarithromycin, rifampicin and erythromycin; or an antibacterially effective derivative of any of these compounds, to a mammal suspected of having or being at risk of having an infection with atypical upper respiratory pathogenic bacteria.
It is preferred in the methods of the invention that said contacting is performed once daily.
Various changes and modifications within the spirit and scope of the disclosed invention will become readily apparent to those skilled in the art from reading the following descriptions and from reading the other parts of the present disclosure.
DESCRIPTION OF THE INVENTION
The present invention provides, among other things, methods for using a composition comprising a gemifloxacin compound against atypical upper respiratory pathogenic bacteria, especially a member of the genus Legionella, a member of the genus, Pseudomonas,
Pseudomonas aeruginosa
strain, a
L. pneumophila
strain, a
L. pneumophila serogroup
1, a
L. pneumophila
serogroup 2, a
L. pneumophila
serogroup 3, a
L. pneumophila
serogroup 4, a
L. pneumophila
serogroup 5, a
L. pneumophila
serogroup 6, a
L. pneumophila
serogroup 7, a
L. pneumophila
serogroup 8, a
L. dumoffii
strain, a
L. longbeacheae
strain, a
L. micdadei
strain, a
L. oakridgensis
strain, a
L. feelei
strain, a
L. anisa
strain, a
L. sainthelensi
strain, a
L. bozemanii
strain, a
L. gormanii
strain, a
L. wadsworthii
strain, a
L. jordanis
strain or a
L. gormanii
strain.
As used herein “gemifloxacin compound(s)” means a compound having antibacterial activity described in patent application PCT/KR98/00051 published as WO 98/42705, or patent application EP 688772.
This invention was based, in part, on analyses evaluating the in vitro activity and postantibiotic effect (herein “PAE”) of gemifloxacin compared with those of trovafloxacin, moxifloxacin, grepafloxacin, levofloxacin, ofloxacin, ciprofloxacin, azithromycin, clarithromycin, erythromycin and rifampicin against isolates of
Legionella pneumophila
and other Legionella spp. Test isolates included
L. pneumophila
serogroup 1-12 (204),
L. dumoffii
(10),
L. micdadei
(10) and
L. longbeacheae
(7). The PAE was determined by exposing the isolates to the test antimicrobials for 1 hour at four times the minimum inhibitory concentration (herein “MIC”). The antimicrobial was removed by three consecutive centrifugations into fresh broth. The PAE was calculated by measuring bacterial growth kinetics in similar antimicrobial-free cultures. Rifampicin and trovafloxacin were the most active agents tested (MIC
90
≦0.008 mg/L). Gemifloxacin displayed high potency (MIC
90
0.016 mg/L) which was comparable to l
Dubois Jacques
St-Pierre Claude
Gimmi Edward R.
Henderson Loretta J.
King William T.
SmithKline Beecham Corporation
Spivack Phyllis G.
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