Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2000-12-19
2003-09-02
Smith, Lynette R. F. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S234100, C435S069300, C435S320100, C435S282000
Reexamination Certificate
active
06613335
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to polynucleotides, (herein referred to as “BASB011 polynucleotide(s)”), polypeptides encoded by them (referred to herein as “BASB011” or “BASB011 polypeptide(s)”), recombinant materials and methods for their production. In another aspect, the invention relates to methods for using such polypeptides and polynucleotides, including vaccines against bacterial infections. In a further aspect, the invention relates to diagnostic assays for detecting infection of certain pathogens.
BACKGROUND OF THE INVENTION
Moraxella catarrhalis
(also named
Branhamella catarrhalis
) is a Gram negative bacteria frequently isolated from the human upper respiratory tract. It is responsible for several pathologies the main ones being otitis media in infants and children, and pneumonia in elderlies. It is also responsible of sinusitis, nosocomial infections and less frequently of invasive diseases.
Otitis media is an important childhood disease both by the number of cases and its potential sequelae. More than 3.5 millions cases are recorded every year in the United States, and it is estimated that 80% of the children have experienced at least one episode of otitis before reaching the age of 3 (Klein, JO (1994) Clin.Inf.Dis 19:823). Left untreated, or becoming chronic, this disease may lead to hearing losses that could be temporary (in the case of fluid, accumulation in the middle ear) or permanent (if the auditive nerve is damaged). In infants, such hearing losses may be responsible for a delayed speech learning.
Three bacterial species are primarily isolated from the middle ear of children with otitis media:
Streptococcus pneumoniae,
non typeable
Haemophilus influenza
(NTHi) and
M. catarrhalis.
They are present in 60 to 90% of the cases. A review of recent studies shows that
S. pneumoniae
and NTHi represent both about 30%, and
M. catarrhalis
about 15% of the otitis media cases (Murphy, TF (1996) Microbiol.Rev. 60:267). Other bacteria could be isolated from the middle ear (
H. influenza
type B,
S. pyogenes
etc) but at a much lower frequency (2% of the cases or less).
Epidemiological data indicate that, for the pathogens found in the middle ear, the colonization of the upper respiratory tract is an absolute prerequisite for the development of an otitis; other are however also required to lead to the disease (Dickinson, DP et al. (1988) J. Infect.Dis. 158:205, Faden, HL et al. (1991) Ann.Otorhinol.Laryngol. 100:612). These are important to trigger the migration of the bacteria into the middle ear via the Eustachian tubes, followed by the initiation of an inflammatory process. These factors are unknown todate. It has been postulated that a transient anomaly of the immune system following a viral infection, for example, could cause an inability to control the colonization of the respiratory tract (Faden, HL et al (1994) J. Infect.Dis. 169:1312). An alternative explanation is that the exposure to environmental factors allow a more important colonization of some children, who subsequently become susceptible to the development of otitis media because of the sustained presence of middle ear pathogens (Murphy, TF (1996) Microbiol.Rev. 60:267).
The immune response to
M. catarrhalis
is poorly characterized. The analysis of strains isolated sequentially from the nasopharynx of babies followed from 0 to 2 years of age, indicates that they get and eliminate frequently new strains. This indicates that an efficacious immune response against this bacteria is mounted by the colonized children (Faden, HL et al (1994) J. Infect.Dis. 169:1312).
In most adults tested, bactericidal antibodies have been identified (Chapman, AJ et al. (1985) J. Infect.Dis. 151:878). Strains of
M. catarrhalis
present variations in their capacity to resist serum bactericidal activity: in general, isolates from diseased individuals are more resistant than those who are simply colonized (Hol, C et al. (1993) Lancet 341:1281, Jordan, KL et al. (1990) Am.J.Med. 88 (suppl 5A):28S). Serum resistance could therefore be considered as a virulence factor of the bacteria. An opsonizing activity has been observed in the sera of children recovering from otitis media.
The antigens targetted by these different immune responses in humans have not been identified, with the exception of OMP B1, a 84 kDa protein which expression is regulated by iron, and that is recognized by the sera of patients with pneumonia (Sethi, S, et al. (1995) Infect.Immun. 63:1516), and of UspA1 and UspA2 (Chen D. et al.(1999), Infect.Immun. 67:1310).
A few other membrane proteins present on the surface of
M. catarrhalis
have been characterized using biochemical method, or for their potential implication in the induction of a protective immunity (for review, see Murphy, TF (1996) Microbiol.Rev. 60:267). In a mouse pneumonia model, the presence of antibodies raised against some of them (UspA, CopB) favors a faster clearance of the pulmonary infection. Another polypeptide (OMP CD) is highly conserved among
M. catarrhalis
strains, and present homologies with a porin of
Pseudomonas aeruginosa,
which has been demonstrated efficacious against this bacterium in animal models.
The frequency of
Moraxella catarrhalis
infections has risen dramatically in the past few decades. This has been attributed to the emergence of multiply antibiotic resistant strains and an increasing population of people with weakened immune systems. It is no longer uncommon to isolate
Moraxella catarrhalis
strains that are resistant to some or all of the standard antibiotics. This phenomenon has created an unmet medical need and demand for new anti-microbial agents, vaccines, drug screening methods, and diagnostic tests for this organism.
SUMMARY OF THE INVENTION
The present invention relates to BASB011, in particular BASB011 polypetides and BASB011 polynucleotides, recombinant materials and methods for their production. In another aspect, the invention relates to methods for using such polypeptides and polynucleotides, including prevention and treatment of microbial diseases, amongst others. In a further aspect, the invention relates to diagnostic assays for detecting diseases associated with microbial infections and conditions associated with such infections, such as assays for detecting expression or activity of BASB011 polynucleotides or polypeptides.
REFERENCES:
patent: WO 95/09025 (1995-04-01), None
patent: WO 96/12733 (1996-05-01), None
patent: WO 96/34960 (1996-11-01), None
patent: WO-97/09428 (1997-03-01), None
patent: WO-97/09429 (1997-03-01), None
patent: WO 97/41731 (1997-11-01), None
patent: WO 98/06432 (1998-02-01), None
Van de Loo et al. ,Proc. Natl. Acad. Sci , vol. 92, pp. 6743-6747 Jul., 1995.*
Broun et al. ,Science , vol. 282, pp. 1315-1317 , Nov. 1998.*
Sequence search for US 09/673,899 SEQ ID #2.*
Sequence search for US 09/673,899 SEQ ID #4.*
Kyd, et al. , Vaccine , vol. 18, pp. 398-406 ,2000.*
Gu, et al. Infection and Immunity, vol. 66, No. 5, pp. 1891-1897, May 1998.*
Samukawa et al. Journal of Infections Disease vol. 181 . pp. 1842-1845 May 2000.*
Hu et al. Infection and Immunity vol. 68 No. 9 pp. 4980-4985 Sep. 2000.*
Chen et al. Infection and Immunity vol. 64 No. 6 pp. 1900-1905, Jun. 1996.*
Amer. J. of Medicine. 88(suupl 5A): 5A-43S, 1990 (Murphy). Studies of the Outer Membrane Proteins of Branhamella catarrhalis.
Microbiological Reviews 60(2):267-279, 1996 (Murphy). Branhamella catarrhalis: Epidemiology, Surface Antigenic Structure, and Immune Response.
Bittenbender Teresa O.
Meade Eric A.
Shahnan-Shah Khatol S
Smith Lynette R. F.
SmithKline Beecham Biologicals (s.a.)
LandOfFree
Polypeptides from moraxella (branhamella) catarrhalis does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Polypeptides from moraxella (branhamella) catarrhalis, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Polypeptides from moraxella (branhamella) catarrhalis will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3084711