"borrelia burgdorferi": 650 patents.
- From: "georgia" <jwissmille@xxxxxxx>
- Date: 12 Sep 2005 14:10:08 -0700
http://www.uspto.gov/patft/index.html
Reading some of the many patent applications for Borrelia
burgdorferi's
parts seems to indicate that the disease is not rare and is dangerous.
georgia
Results of Search in 1976 to present of the patent database:
"borrelia burgdorferi": 650 patents.
Example of one application:
United States Patent 6,838,247
Whitaker , et al. January 4, 2005
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Test for lyme disease
Abstract
The present invention provides an accurate method to identify and
quantify
the Borrelia burgdorferi (Bb) antigen, the cause of Lyme Disease, in a
sample of
whole blood, body tissues and fluids of a subject, a human or animal
subject.
The qualitative method provides a quick, easy and accurate method of
detection of the Bb antigen. The quantitative method allows for
monitoring of
treatment in conjunction with severity of clinical signs and symptoms.
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Inventors: Whitaker; Jo Anne (Tarpon Springs, FL); Fort; Eleanor G.
(Tarpon
Springs, FL); Hamilton; Donna M. (Holiday, FL)
Assignee: Bowen Research and Training (Palm Harbor, FL)
Appl. No.: 174664
Filed: June 19, 2002
"........The polymerase chain reaction (PCR) is a sensitive and
valuable
diagnostic laboratory test to validate many different diseases,
however, in Lyme
disease, due to low numbers of Bb organisms, it is frequently falsely
negative...."
Description
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--
The invention relates to new methods for detecting the Borrelia
burgdorferi
(Bb) antigen, the causative agent of Lyme disease. These new methods
provide
physicians with an early, accurate and quick method for diagnosing Lyme
disease
and a quantitative method to aid in monitoring therapy.
Lyme disease is called the "New Great Imitator" because, like syphilis,
it
attacks multiple organ systems and mimics many diseases. Both diseases
are
caused by a spirochete. Lyme disease is caused by Borrelia burgdorferi
(Bb), an
elongated spiral shaped spirochete that infects humans and animals,
carried by
the deer tick (Ixodes scapularis). It is also transported by the common
dog
(wood) tick, deer flies, mosquitoes, birds and the white-footed mouse.
Mattman and
Whitaker's laboratories have found Bb in California and Florida
mosquitoes.
Lyme Disease, previously known as the most common tick-borne disease in
the
United States, now known to be carried by many "blood sucking" vectors,
has
become a serious global problem.
Lyme disease is a multi-system illness producing symptoms of fatigue,
joint
pain, muscle pain, as well as digestive, respiratory, endocrine,
urinary,
reproductive and nervous system problems. A critical review of the
literature
indicates that alterations in mood, memory and sleep are prominent
features of this
illness. Initial symptoms include acute headache, backache, chills,
flu-like
symptoms, fatigue and, some have a typical Erythema migrans (EM) rash
at the
biting site.
If ignored, the early symptoms may disappear, but more serious problems
can
develop months to years later. The later symptoms of Lyme disease can
be quite
severe and chronic. Fatigue, muscle and joint pain, arthritis of the
large
joints is common. Neurological symptoms include cognitive impairment,
memory
loss, depression, numbness, tingling and burning sensations in the
extremities and
Bell's palsy. Involvement of all systems such as heart, eye respiratory
and
gastrointestinal problems can develop. Premature births, stillbirths,
birth
defects and transplacental infection of the fetus have been reported.
Symptoms
are often intermittent lasting from a few days to several months and
sometimes
years. Chronic Lyme disease, because of its diverse symptoms, mimics
many other
diseases and can be difficult to diagnose.
Treatment
Successful management and treatment of Lyme disease rests on early and
accurate diagnosis. Timely treatment increases chances of recovery and
may lessen
the severity of any later symptoms. The most effective treatment will
depend on
how soon antibiotics are started after the bite of a vector infected
with Bb.
Treatment for later stages is more difficult often requiring extended
and
repeated courses of antibiotic therapy. The diagnostic tests now being
used for
Lyme disease are neither sensitive nor specific and consequently
results are not
reliable.
It is well known that the serologic blood test for Lyme is insensitive,
inaccurate and misses more than forty percent (40%) of cases. It is
important to
understand the nature of the Bb organism. Bb can change its shape from
a spiral
to a filament, cyst, granule, hooked rod or elbow. These variants are
called
L-forms, a name given by the Lister Institute where they were first
studied.
These L-forms are also called cell-wall deficient (CWD) bacteria taking
the
non-spiral shape when they have lost much of the cell wall. In this
form, they do
not produce an antibody response, as they have no cell wall surface
components
for the individual's immune systems to recognize as foreign. Classic
L-forms
are active metabolism centers for the production of CWD pleomorphic Bb
organisms. In this form they are able to hide within most tissues in
the body, thus
protecting them from any host response adverse to their well-being. CWD
organisms can revert to typical morphology and may revert into adult
forms of other
genera, depending on the milieu. For this reason most of the diagnostic
tests
like the ELISA and the Western Blot, which depend on the production of
antibodies, are inadequate. Much like the hepatitis model, antigen is
present early
after initial infection. Later there is an antibody response in about
70% of
patients. Tests that look for antibody response will not support an
early
diagnosis, nor reliably confirm presence of the disease.
The ELISA is the most commonly used screening test for the primary
diagnosis
of Lyme disease but if positive has to be confirmed by the Western
Blot. This
test is recommended at least four weeks after exposure and consequently
is not
helpful in making an early definitive diagnosis. Both the ELISA and the
Western Blot are not quantitative and do not assess the severity of an
infection.
The polymerase chain reaction (PCR) is a sensitive and valuable
diagnostic
laboratory test to validate many different diseases, however, in Lyme
disease,
due to low numbers of Bb organisms, it is frequently falsely negative.
One
possibility is that the Borellia genome contains many plasmids, which
may vary
their expression altering the proteins analyzed by a PCR analysis. This
allows
Borellia to evade PCR analysis the same way it evades our own bodies'
immune
system.
____________________________
"......Although a high titre of antibodies against B. burgdorferi is
usually
found during infection in persons afflicted by Lyme disease, this does
not
protect against the infection........"
United States Patent 6,761,891
Simon , et al. July 13, 2004
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Medicament for treating a manifested lyme disease
DESCRIPTION
The invention concerns a pharmaceutical composition for treating Lyme
disease
and a vaccine against Lyme disease and it also concerns a process for
obtaining an active agent for treating Lyme disease and a process for
obtaining a
vaccine against Lyme disease.
Lyme borreliosis is an infectious disease transmitted by ticks and is
caused
by the spirochete Borrelia burgdorferi. The disease is a chronic,
progressive
infection which attacks many organs, such as the skin, the central and
peripheral nervous system, the heart, the liver, the kidneys, the
musculoskeletal
system and joints. Various symptoms such as acute arthritis and
neuroborreliosis
can disappear spontaneously but usually reoccur episodically.
Spirochetes have
been repeatedly isolated from untreated patients and there are numerous
indications for persistent infections even after treatment with
antibiotics. Since
a dependable treatment of this disease by therapy with antibiotics is
difficult, great efforts are being made to investigate the pathogen
itself and the
immune response of the host to infection with B. burgdorferi. Although
a high
titre of antibodies against B. burgdorferi is usually found during
infection in
persons afflicted by Lyme disease, this does not protect against the
infection.
It was found that the outer surface lipoprotein A (OspA) of B.
burgdorferi
could be an effective vaccine for the prevention of Lyme disease (EP 0
418 827).
Laboratory investigations on mice have shown that a substantial
protection
against the disease and infection can be obtained by OspA-specific
antibodies
(Schaible et al., Proc. Natl. Acad. Sci. USA 87 (1990), 3768-3772).
However, these antibodies are only effective if they are present when
the
pathogen is transmitted. A reason for this may be that OspA is mainly
expressed
on spirochetes in ticks but is no longer expressed after transmission
to a
mammalian host. Consequently it is indeed possible to use OspA-specific
antibodies
to prevent transmission of the disease but they are ineffective and
thus
unsuitable for therapeutic applications to treat the manifest disease.
Recent
investigations have shown that mice can be protected against a
tick-transmitted
infection after active immunization with recombinant OspC (Preac-Mursic
et al.,
Infection 20 (1992), 342-349; R. D. Gilmore et al., Infect. Immun. 64
(1996),
2234-2239). However, the immunization protocol used in these
investigations
does not lead to an elimination of infectious spirochetes from the
vector as was
shown for the OspA-specific antibodies..."
.
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