Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
1999-12-15
2001-11-13
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S030000, C514S924000
Reexamination Certificate
active
06316433
ABSTRACT:
FIELD OF THE INVENTION
The current invention concerns a method for treatment of bacterial infections with rifalazil administered once-weekly or twice-weekly. In particular, the invention concerns a method for treatment of tuberculosis caused by
Mycobacterium tuberculosis
, infections caused by
Mycobacterium avium
complex, infections caused by
Chlamydia pneumoniae
and infections caused by
Helicobacter pylori
by administering to a patient suffering from the bacterial infection rifalazil once or twice a week. In this dose regimen, the treatment is fast, efficacious and eliminates undesirable secondary symptoms observed with daily doses of 1-50 mg of rifalazil.
BACKGROUND AND RELATED DISCLOSURES
Bacterial infection caused by mycobacterium species and similar infections caused by
Chlamydia pneumoniae
or
H. pylori
cause serious health problems in the United States and worldwide. For example, tuberculosis, caused by
Mycobacterium tuberculosis
is one of the most serious infectious diseases outside of developed countries, with over one billion people infected worldwide. The worldwide infection rate results in eight million active tuberculosis cases annually and over two million deaths per year. In the United States, 26,000 near cases of active tuberculosis were reported in 1994. The number of active cases in the United States is high because of the increase in patients with AIDS and the increase in immigration from developing countries. Moreover, there is reported an increase in multidrug resistance tuberculosis and disseminated
Mycobacterium avium
complex infections.
Additionally, there is an increase in transmissible chlamydial diseases caused by
Chlamydia pneumoniae
, nonmotile, obligate intracellulare to bacteria.
Chlamydia pneumoniae
causes respiratory infections, such as pneumonia, bronchitis, pharyngitis and sinusitis, and has been associated with about 10% of community-acquired pneumonia. The
Chlamydia pneumoniae
infections are geographically wide spread. Studies on antibody prevalence have shown that large number of people is infected with
Chlamydia pneumoniae
at one time or another.
Helicobacter pylori
infections are infections of gastrointestinal tract.
H. pylori
is a gram-negative microphilic organism residing in human stomach and intestine which is closely connected with acute gastritis and development of inflammation of mucous layer. Acute gastritis is associated with epigastric pain, nausea and vomiting. The organism is difficult to treat, delayed recurrences are frequent, and treatment involves multiple antibiotic regimens.
It would thus be highly advantageous to provide a method for treatment of the above-described diseases with new types of antibiotics which are able to efficaciously treat and/or eradicate the bacteria or organisms causing these diseases without necessity to utilize complex antibiotic treatments and, regimens which result in undesirable secondary symptoms and, adverse reactions.
It is, therefore, an object of this invention to provide a method for treatment of Mycobacterium species,
Chlamydia pneumoniae
and
H. pylori
infections with once a week or twice a week administration of a relatively new antibiotic, rifalazil, that belongs to the class of antibiotics called ansamycins. Rifalazil has the same or better activity than either rifabutin or rifampin, the other two antibiotics of the same class and actively inhibits the growth of
Mycobacterium tuberculosis, Mycobacterium avium
species,
Chlamydia pneumoniae
and
H. pylori
when administered only once a week or twice a week in doses from 1 to 50 mg. Previously, rifalazil has been administered on daily basis and because of the severe secondary adverse reactions, was discontinued as a drug for treatment of tuberculosis and other infection. Newly discovered once-week or twice-week regimen has the same efficacy as daily administration and yet eliminates or significantly decreases the adverse reactions.
Rifalazil compound has been described in the U.S. Pat. No. 4,983,602 where its antibacterial activity has been disclosed. Dosages described in vitro and in mice animal models correspond to a dose from 10 mg to 10 g/day for adults. However, when clinical trials with these doses of the antibiotic were administered daily, many adverse reactions occurred and the treatment with rifalazil was discontinued.
All patents, patent applications and publications cited herein are hereby incorporated by reference.
SUMMARY OF THE INVENTION
One aspect of the current invention is a method for treatment of bacterial infections with once or twice-week administration of rifalazil.
Another aspect of the current invention is a method for treatment of tuberculosis with once or twice-week: administration of rifalazil.
Still another aspect of the current invention is a method for treatment of
Mycobacterium avium
complex infections with once or twice-week administration of rifalazil.
Still another aspect of the current invention is a method for treatment of
Chlamydia pneumoniae
infections with once or twice-week administration of rifalazil.
Yet another aspect of the current invention is a method for treatment of
Helicobacter pylori
infections with once or twice-week administration of rifalazil.
REFERENCES:
patent: 4983602 (1991-01-01), Takehiko et al.
patent: 5786349 (1998-07-01), Katsuji et al.
patent: 9602464 (1996-08-01), None
Klemens et al., “Activity of KRM-1648 in combination with isoniazide aganist Mycobacterium tuberulosis in murine model”, Antimicrob. Agents Chemother. (1996), 40(2), 298-301 (abstract).*
Bermudez et al., “Activity of KRM-1648 alone or in combination with ethambutol or clarithromycin aganist Mycobacterium avium in beige mouse model of disseminated infection”, Antimicrob. Agents Chemothe (1994), 38(8), 1844-1848.*
Norio Doi, Therapeutic Efficacy of Benzoxazinorifamycin KRM-1648 Against Experimental Murine Tuberculosis: A Study on the Efficacy of Short Course Treatment with the Intratracheal and Intravenous Infection Models,Kekkaku, 73:2, 53-64 (1998).
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Animal Models Murine Model with Low-Dose Aerosol Infection Useful,Tuberculosis&Airborne Disease Weekly, p. 3, (Feb. 10, 1997).
Alan D. Henderson, Journal Article Summaries,TBWeekly, (Jan. 20, 1997).
K. Sato, et al., Antimicrobial Activities of Benzoxazinorifamycin KRM-1648, Clarithromycin and Levofloxacin Against IntracellularMycobacterium aviumComplex Phagocytosed by Murine Peritoneal Macrophages,Journal of Antimicrobial Chemotherapy, 41:77-83, (1998).
Haruaki Tomioka, et al., Therapeutic Efficacy Of Benzoxazinorifamycin, JRM-1648, Administered in Various Frequencies Per Week inMycobacterium Intracellulare-Infected Mice,Kekkaku, 68(11):683-686 (1993).
Montgomery Alan B.
Porubek David J.
Rose Lynn M.
Kaneka Corporation
Verny Hana
Weddington Kevin E.
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