Title: Compositions including different types of transfer factor, methods for making the compositions, and methods of treatment using the compositions
Abstract: A composition for eliciting a T-cell mediated immune response in a subject includes transfer factor from at least two different types of source animals. For example, the composition may include mammalian transfer factor and nonmammalian transfer factor. An example of the composition includes a combination of a colostrum-derived product, which includes the mammalian transfer factor, and an egg-derived product, which includes the nonmammalian transfer factor. Additionally, the egg-derived product may be substantially free of fat. Methods for forming the composition and eliciting T-cell mediated immune responses in subjects that have been treated with the composition are also disclosed.
Patent Number: 6,866,868 Issued on 03/15/2005 to Lisonbee, et al.
| Inventors:
|
Lisonbee; David (Sandy, UT);
Hennen; William J. (Springville, UT);
Daugherty; F. Joseph (Omaha, NE)
|
| Assignee:
|
4Life Research, LC (Sandy, UT)
|
| Appl. No.:
|
663353 |
| Filed:
|
September 15, 2003 |
| Current U.S. Class: |
424/535; 424/581 |
| Intern'l Class: |
A61K 035//20 |
| Field of Search: |
424/535,581
|
References Cited [Referenced By]
U.S. Patent Documents
| 4816563 | Mar., 1989 | Wilson et al.
| |
| 6468534 | Oct., 2002 | Hennen et al.
| |
| 2002/0044942 | Apr., 2002 | Dopson.
| |
| Foreign Patent Documents |
| 914831 | May., 1999 | EP.
| |
| 930316 | Jul., 1999 | EP.
| |
Primary Examiner: Witz; Jean C.
Attorney, Agent or Firm: TraskBritt, PC
Claims
What is claimed:
1. A method for reducing the cleaning frequency of processing equipment
used for capsulating an egg-derived product, comprising:
combining a colostrum-derived product with an egg-derived product before or
during introduction of the egg-derived product into the capsulation
equipment.
2. The method of claim 1, wherein said combining comprises combining about
equal weights of said colostrum-derived product and the egg-derived
product.
3. The method of claim 1, wherein said combining comprises combining said
colostrum-derived product in a greater amount, by weight, than the
egg-derived product with the egg-derived product.
4. The method of claim 1, wherein said combining comprises combining said
colostrum-derived product, in a lesser amount, by weight, than the
egg-derived product with the egg-derived product.
5. The method of claim 1, further comprising:
defatting the egg-derived product.
6. The method of claim 1, further comprising:
combining at least one vitamin with at least one of the egg-derived product
and said colostrum-derived product.
7. The method of claim 1, wherein said combining comprises combining said
colostrum-derived product and the egg-derived product with at least one of
said colostrum-derived product and the egg-derived product including
transfer factor.
8. A method for reducing the cleaning frequency of equipment used for
processing an egg-derived product, comprising:
combining a colostrum-derived product with an egg-derived product before or
during introduction of the egg-derived product into the equipment.
9. The method of claim 8, wherein said combining comprises combining about
equal weights of said colostrum-derived product and the egg-derived
product.
10. The method of claim 8, wherein said combining comprises combining said
colostrum-derived product in a greater amount, by weight, than the
egg-derived product with the egg-derived product.
11. The method of claim 8, wherein said combining comprises combining said
colostrum-derived product, in a lesser amount, by weight, than the
egg-derived product with the egg-derived product.
12. The method of claim 8, further comprising:
defatting the egg-derived product.
13. The method of claim 8, further comprising:
combining at least one vitamin with at least one of the egg-derived product
and said colostrum-derived product.
14. The method of claim 8, wherein said combining comprises combining said
colostrum-derived product and the egg-derived product with at least one of
said colostrum-derived product and the egg-derived product including
transfer factor.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to compositions which include
transfer factor and, more specifically, to compositions which include
transfer factor from different types of source animals. The present
invention also relates to methods for making compositions that include
different types of transfer factor and to methods for eliciting or
enhancing a T-cell mediated immune response by the immune system of a
subject.
2. Background of Related Art
Many, deadly pathogens are passed to humans from the animal kingdom. For
example, monkeys are the sources of the type I human immunodeficiency
virus (HIV-I), which causes acquired immune deficiency syndrome (AIDS) and
monkeypox, which is similar to smallpox; ground-dwelling mammals are
believed to be the source of the Ebola virus; fruit bats and pigs are the
source of the Nipah virus; the Hendra virus comes from horses; the virus
responsible for the "Hong Kong Flu" originated in chickens; and wild
birds, especially ducks, are the sources of many of the deadly influenza
viruses. Many diseases also have animal reservoirs. By way of example,
mice carry Hanta virus, rats carry the Black Plague, and deer carry Lyme
disease.
The Immune System
The immune systems of vertebrates are equipped to recognize and defend the
body from invading pathogenic organisms, such as parasites, bacteria,
fungi, and viruses. Vertebrate immune systems typically include a cellular
component and a noncellular component.
The cellular component of an immune system includes the so-called
"lymphocytes," or white blood cells, of which there are several types. It
is the cellular component of a mature immune system that typically mounts
a primary, non-specific response to invading pathogens, as well as being
involved in a secondary, specific response to pathogens.
In the primary, or initial, response to an infection by a pathogen, white
blood cells that are known as phagocytes locate and attack the invading
pathogens. Typically, a phagocyte will internalize, or "eat" a pathogen,
then digest the pathogen. In addition, white blood cells produce and
excrete chemicals in response to pathogenic infections that are intended
to attack the pathogens or assist in directing the attack on pathogens.
Only if an infection by invading pathogens continues to elude the primary
immune response is a specific, secondary immune response to the pathogen
needed. As this secondary immune response is typically delayed, it is also
known as "delayed-type hypersensitivity." A mammal, on its own, will
typically not elicit a secondary immune response to a pathogen until about
seven (7) to about fourteen (14) days after becoming infected with the
pathogen. The secondary immune response is also referred to as an acquired
immunity to specific pathogens. Pathogens have one or more characteristic
proteins, which are referred to as "antigens." In a secondary immune
response, white blood cells known as B lymphocytes, or "B-cells," and T
lymphocytes, or "T-cells," "learn" to recognize one or more of the
antigens of a pathogen. The B-cells and T-cells work together to generate
proteins called "antibodies," which are specific for (e.g., configured to
bind to or otherwise "recognize") one or more certain antigens on a
pathogen.
The T-cells are primarily responsible for the secondary, or delayed-type
hypersensitivity, immune response to a pathogen or antigenic agent. There
are three types of T-cells: T-helper cells, T-suppressor cells, and
antigen-specific T-cells, which are also referred to as cytotoxic (meaning
"cell-killing") T-lymphocytes (CTLs), or T-killer cells or natural killer
(NK) cells. The T-helper and T-suppressor cells, while not specific for
certain antigens, perform conditioning functions (e.g., the inflammation
that typically accompanies an infection) that assist in the removal of
pathogens or antigenic agents from an infected host.
Antibodies, which make up only a part of the noncellular component of an
immune system, recognize specific antigens and, thus, are said to be
"antigen-specific." The generated antibodies then basically assist the
white blood cells in locating and eliminating the pathogen from the body.
Typically, once a white blood cell has generated an antibody against a
pathogen, the white blood cell and all of its progenitors continue to
produce the antibody. After an infection is eliminated, a small number of
T-cells and B-cells that correspond to the recognized antigens are
retained in a "resting" state. When the corresponding pathogenic or
antigenic agents again infect the host, the "resting" T-cells and B-cells
activate and, within about forty-eight (48) hours, induce a rapid immune
response. By responding in this manner, the immune system mounts a
secondary immune response to a pathogen, the immune system is said to have
a "memory" for that pathogen.
Mammalian immune systems are also known to produce smaller proteins, known
as "transfer factors," as part of a secondary immune response to infecting
pathogens. Transfer factors are another noncellular part of a mammalian
immune system. Antigen-specific transfer factors are believed to be
structurally analogous to antibodies, but on a much smaller molecular
scale. Both antigen-specific transfer factors and antibodies include
antigen-specific sites. In addition, both transfer factors and antibodies
include highly conserved regions that interact with receptor sites on
their respective effector cells. In transfer factor and antibody
molecules, a third, "linker," region connects the antigen-specific sites
and the highly conserved regions.
The Role of Transfer Factor in the Immune System
Transfer factor is a low molecular weight isolate of lymphocytes. Narrowly,
transfer factors may have specificity for single antigens. U.S. Pat. Nos.
5,840,700 and 5,470,835, both of which issued to Kirkpatrick et al.
(hereinafter collectively referred to as "the Kirkpatrick Patents"),
disclose the isolation of transfer factors that are specific for certain
antigens. More broadly, "specific" transfer factors have been generated
from cell cultures of monoclonal lymphocytes. Even if these transfer
factors are generated against a single pathogen, they have specificity for
a variety of antigenic sites of that pathogen. Thus, these transfer
factors are said to be "pathogen-specific" rather than antigen-specific.
Similarly, transfer factors that are obtained from a host that has been
infected with a certain pathogen are pathogen-specific. Although such
preparations are often referred to in the art as being "antigen-specific"
due to their ability to elicit a secondary immune response when a
particular antigen is present, transfer factors having different
specificities may also be present in such preparations. Thus, even the
so-called "antigen-specific," pathogen-specific transfer factor
preparations may be specific for a variety of antigens.
Additionally, it is believed that antigen-specific and pathogen-specific
transfer factors may cause a host to elicit a delayed-type
hypersensitivity immune response to pathogens or antigens for which such
transfer factor molecules are not specific. Transfer factor "draws" at
least the non-specific T-cells, the T-inducer and the T-suppressor cells,
to an infecting pathogen or antigenic agent to facilitate a secondary, or
delayed-type hypersensitivity, immune response to the infecting pathogen
or antigenic agent.
Typically, transfer factor includes an isolate of proteins having molecular
weights of less than about 10,000 daltons (D) that have been obtained from
immunologically active mammalian sources. It is known that transfer
factor, when added either in vitro or in vivo to mammalian immune cell
systems, improves or normalizes the response of the recipient mammalian
immune system.
The immune systems of newborns have typically not developed, or "matured,"
enough to effectively defend the newborn from invading pathogens.
Moreover, prior to birth, many mammals are protected from a wide range of
pathogens by their mothers. Thus, many newborn mammals cannot immediately
elicit a secondary response to a variety of pathogens. Rather, newborn
mammals are typically given secondary immunity to pathogens by their
mothers. One way in which mothers are known to boost the immune systems of
newborns is by providing the newborn with a set of transfer factors. In
mammals, transfer factor is provided by a mother to a newborn in
colostrum, which is typically replaced by the mother's milk after a day or
two. Transfer factor basically transfers the mother's acquired, specific
(i.e., delayed-type hypersensitive) immunity to the newborn. This
transferred immunity typically conditions the cells of the newborn's
immune system to react against pathogens in an antigen-specific manner, as
well as in an antigen- or pathogen-nonspecific fashion, until the
newborn's immune system is able on its own to defend the newborn from
pathogens. Thus, when transfer factor is present, the immune system of the
newborn is conditioned to react to pathogens with a hypersensitive
response, such as that which occurs with a typical delayed-type
hypersensitivity response. Accordingly, transfer factor is said to "jump
start" the responsiveness of immune systems to pathogens.
Much of the research involving transfer factor has been conducted in recent
years. Currently, it is believed that transfer factor is a protein with a
length of about forty-four (44) amino acids. Transfer factor typically has
a molecular weight in the range of about 3,000 to about 5,000 Daltons (Da
), or about 3 kDa to about 5 kDa, but it may be possible for transfer
factor molecules to have molecular weights outside of this range. Transfer
factor is also believed to include three functional fractions, each of
which may include different types of transfer factor molecules: an inducer
fraction; an immune suppressor fraction; and an antigen-specific fraction.
Many in the art believe that transfer factor also includes a nucleoside
portion, which could be connected to the protein molecule or separate
therefrom, that may enhance the ability of transfer factor to cause a
mammalian immune system to elicit a secondary immune response. The
nucleoside portion may be part of the inducer or suppressor fractions of
transfer factor.
The antigen-specific region of the antigen-specific transfer factors is
believed to comprise about eight (8) to about twelve (12) amino acids. A
second highly-conserved region of about ten (10) amino acids is thought to
be a very high-affinity T-cell receptor binding region. The remaining
amino acids may serve to link the two active regions or may have
additional, as yet undiscovered properties. The antigen-specific region of
a transfer factor molecule, which is analogous to the known
antigen-specific structure of antibodies, but on a much smaller molecular
weight scale, appears to be hyper-variable and is adapted to recognize a
characteristic protein on one or more pathogens. The inducer and immune
suppressor fractions are believed to impart transfer factor with its
ability to condition the various cells of the immune system so that the
cells are more fully responsive to the pathogenic stimuli in their
environment.
Sources of Noncellular Immune System Components
Conventionally, transfer factor has been obtained from the colostrum of
milk cows, such as by the method described in U.S. Pat. No. 4,816,563 to
Wilson et al. (hereinafter "Wilson"). While milk cows typically produce
large amounts of colostrum and, thus, large amounts of transfer factor
over a relatively short period of time, milk cows only produce colostrum
for about a day or a day-and-a-half every year. Thus, milk cows are
neither a constant source of transfer factor nor an efficient source of
transfer factor.
Transfer factor has also been obtained from a wide variety of other
mammalian sources. For example, in researching transfer factor, mice have
been used as a source for transfer factor. Antigens are typically
introduced subcutaneously into mice, which are then sacrificed following a
delayed-type hypersensitivity reaction to the antigens. Transfer factor is
then obtained from spleen cells of the mice.
While different mechanisms are typically used to generate the production of
antibodies, the original source for antibodies may also be mammalian. For
example, monoclonal antibodies may be obtained by injecting a mouse, a
rabbit, or another mammal with an antigen, obtaining antibody-producing
cells from the mammal, then fusing the antibody-producing cells with
immortalized cells to produce a hybridoma cell line, which will continue
to produce the monoclonal antibodies throughout several generations of
cells and, thus, for long periods of time.
Antibodies against mammalian pathogens have been obtained from a wide
variety of sources, including mice, rabbits, pigs, cows, and other
mammals. In addition, the pathogens that cause some human diseases, such
as the common cold, are known to originate in birds. As it has become
recognized that avian (i.e., bird) immune systems and mammalian immune
systems are very similar, some researchers have turned to birds as a
source for generating antibodies.
Avian antibodies that are specific for pathogens that infect mammals, or
"mammalian pathogens," have been obtained by introducing antigens into
eggs. Alternatively, antibodies may be present in eggs following exposure
of the source animal to antigens, including antigens of mammalian
pathogens. U.S. Pat. No. 5,080,895, issued to Tokoro on Jan. 14, 1992
(hereinafter "the '895 patent"), discloses a method that includes
injecting hens with pathogens that cause intestinal infectious diseases in
neonatal mammals. The hens then produce antibodies that are specific for
these pathogens, which are present in eggs laid by the hens. The '895
patent discloses compositions that include these pathogen-specific
antibodies and use thereof to treat and prevent intestinal diseases in
neonatal piglets and calves. Treatment of pathogenic infections in mammals
with avian antibodies may have undesirable results, however, since the
immune systems of mammals may respond negatively to the large avian
antibody molecules by eliciting an immune response to the antibodies
themselves. Moreover, as mammalian immune systems do not recognize avian
antibodies as useful for their abilities to recognize certain pathogens,
or the specificities of avian antibodies for antigens of such pathogens,
avian antibodies often do not elicit the desired immune responses in
mammals.
It is also known that transfer factor may be obtained from eggs. U.S. Pat.
No. 6,468,534 to Hennen et al. (hereinafter "Hennen") describes a process
by which female chickens (i.e., hens) are exposed to one or more antigens,
which results in the elicitation of an immune response, including a
secondary immune response, by the chickens. As a result of the secondary
immune response, transfer factor molecules are present in the eggs of the
chicken. The eggs may then be processed to provide a product in which the
transfer factor is present. Such a product may take the form of a
freeze-dried, or lyophilized, egg powder, and may include all or part of
the egg. The egg powder may then be incorporated directly into gelatin
capsules or mixed with other substances, then introduced into gelatin
capsules.
FIG. 2 schematically depicts capsulation equipment of a type that is
currently useful for capsulating egg-derived avian transfer factor in the
form of an egg powder. Capsulation equipment 20 includes a composition
supply hopper 24, a feed station 28, and an auger 26 in communication
between each composition supply hopper 24 and feed station 28. Auger 26
transports the whole egg powder from composition supply hopper 24 to feed
station 28.
When auger 26 operates, it is heated to a temperature which exceeds the
relatively low melting point of cholesterol, from egg yolk, in the whole
egg powder. The warmed cholesterol is sticky, coating auger 26, the
conduit in communication therewith, and feed station 28, thereby
decreasing the efficiency with which capsulation equipment 20 operates.
Consequently, capsulation equipment must be disassembled and cleaned
periodically, which may take a considerable amount of time (e.g., up to
about 8 hours), resulting in a significant decrease in the productivity of
capsulation equipment 20 and, thus, the number of capsules that may be
formed therewith. Thus, processing of whole egg powder to obtain a
transfer factor-containing product is somewhat undesirable.
Additionally, compositions which are derived from products (e.g., eggs or
colostrum) from a single source animal typically only include transfer
factor molecules which have specificity to antigens to which the source
animal has been exposed. The consequence of such limited exposure may be
that the effectiveness of such transfer factor-containing compositions in
preventing or treating certain types of infections or conditions is also
limited.
Accordingly, there is a need for a composition which is useful for causing
an immune system of a treated subject to elicit an immune response to a
broader array of pathogens, as well as for a method for improving the
efficiency and productivity with which capsulation and other
composition-forming equipment operates.
SUMMARY OF THE INVENTION
The present invention includes a composition for eliciting a T-cell
mediated immune response in a subject. The composition includes transfer
factor from at least two different types of source animals. The term
"type," as used herein with respect to source animals, describes the
source animals from which transfer factor may be obtained and refers to
source animals from different classes (e.g. mammals, birds, reptiles,
amphibians, insects, etc.). The term "type," as used herein, also refers
to source animals from different subclasses, orders (e.g., artiodactyls,
primates, carnivores, etc.), families (bovine, hominids, felines, etc.),
subfamilies, genuses (e.g., cattle, humans, domestic cats, etc.), and even
species and subspecies. Use of the term "type" herein with respect to
transfer factor denotes the type of source animal from which the transfer
factor was obtained.
An exemplary embodiment of the composition includes transfer factor from
both mammalian and nonmammalian source animals, which types of transfer
factor are also referred to herein as "mammalian transfer factor" and
"nonmammalian transfer factor," respectively. By way of nonlimiting
example, the mammalian transfer factor may be included in the composition
as colostrum or a fraction or extract thereof, which are collectively
referred to herein as "colostrum-derived products," or otherwise, as known
in the art (e.g., as a leukocyte (white blood cell) extract, as a splenic
("from the spleen") extract, etc.). Also by way of example, the
nonmammalian transfer factor of the exemplary composition may be obtained
from an egg or a fraction or extract thereof, which are also referred to
herein as "egg-derived products."
When a composition of the present invention includes a colostrum-derived
product and an egg-derived product, both products may be included in the
mixture in amounts (e.g., by weight, by volume, etc., of the total
mixture) that are about equal, or more of one of the colostrum-derived
product and the egg-derived product than the other.
In another aspect, the present invention includes a method for capsulating
an egg-derived product which includes transfer factor. The inventive
capsulation method includes mixing a substantially fat-free component,
such as a colostrum-derived product, which may or may not include transfer
factor, with the egg-derived product before or while the egg-derived
product is being introduced into capsulation equipment.
Additionally, the present invention includes a method for reducing the
cleaning frequency of capsulation equipment used for capsulating an
egg-derived product. That method includes mixing a less fatty or
substantially fat-free substance, such as a colostrum-derived product,
with the egg-derived product before or during introduction of the
egg-derived product into the capsulation equipment.
The present invention also includes methods for treating a subject.
Treatment methods that incorporate teachings of the present invention
include administration of a composition according to the present invention
to a subject. As the composition includes transfer factor, administration
of the composition to the subject will cause the subject's immune system
to elicit a T-cell mediated immune response or will enhance a T-cell
mediated immune response by the subject's immune system which is already
underway.
Other features and advantages of the present invention will become apparent
to those of ordinary skill in the art through consideration of the ensuing
description, the accompanying drawings, and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings, which depict exemplary embodiments of various aspects of
the present invention:
FIG. 1 depicts an example of the manner in which a composition that
incorporates teachings of the present invention may be embodied; and
FIG. 2 is a schematic representation of capsulation equipment that may be
used to introduce a powdered embodiment of the composition of the present
invention into gelatin capsules.
DETAILED DESCRIPTION
An exemplary embodiment of composition that incorporates teachings of the
present invention includes transfer factor from at least two different
types of source animals. By way of nonlimiting example, a composition
according to the present invention may include mammalian transfer factor
and nonmammalian transfer factor.
The different types of transfer factor of the inventive composition may be
obtained from any suitable source. For example, mammalian transfer factor
may be obtained from colostrum, as described in Wilson, the disclosure of
which is hereby incorporated herein in its entirety by this reference, or
otherwise, as known in the art (e.g., a leukocyte (white blood cell)
extract, a splenic (i.e., "from the spleen") extract, etc.). An exemplary
source for nonmammalian transfer factor is an egg of an animal, such as a
chicken, as described in Hennen, the disclosure of which is hereby
incorporated herein in its entirety by this reference. Thus, a composition
according to the present invention may include a first component which
comprises a colostrum-derived product, as well as a second component that
comprises an egg-derived product.
As compositions that incorporate teachings of the present invention include
transfer factor from different types of source animals, they may include
transfer molecules with a broader array of antigen-specificity or
pathogen-specificity than conventional transfer factor-containing
compositions. Thus, a composition according to the present invention is
capable of enlisting the immune system of a treated animal to elicit a
T-cell mediated immune response against a broader array of pathogens than
those against which conventional transfer factor-containing compositions
are effective. This is because different types of animals may be exposed
to different types of antigens or pathogens, such as by vaccination, the
animals' environments, or the like.
As an example, a composition which includes transfer factor-containing
components from both cows and chickens will include transfer factor
molecules which are specific to antigens or pathogens to which cows are
exposed, as well as transfer factor molecules that have specificity for
antigens or pathogens to which chickens are exposed. As both cows and
chickens may be exposed to antigens or pathogens to which the other is not
exposed, such a composition may include transfer factor molecules with
antigen or pathogen specificities that would not be present in a
composition that includes only transfer factor from cows (e.g., by way of
a colostrum-derived product) or transfer factor from chickens (e.g.,
through an egg-derived product).
A composition of the present invention may include about the same amounts,
measured in terms of weight or volume, of a colostrum-derived product and
an egg-derived product (i.e., about 50% colostrum-derived product and
about 50% egg-derived product). Alternatively, a composition that
incorporates teachings of the present invention may include more
colostrum-derived product (e.g., about 85% or 60%, by combined weight of
the colostrum-derived product and egg-derived product) than egg-derived
product (about 15% or 40%, by weight). As another alternative, the
inventive composition may include more egg-derived product (e.g., about
60% or 85%, by weight) than colostrum-derived product (e.g., about 40% or
15% by weight). As another example, a composition that incorporates
teachings of the present invention may include about one percent, by
weight, of one of a colostrum-derived product and an egg-derived product
and about 99%, by weight, of the other of the colostrum-derived product
and the egg-derived product. Although specific amounts of
colostrum-derived product and egg-derived product have been provided, any
combination thereof is within the scope of the present invention.
In addition to including a source of transfer factor (e.g., a
colostrum-derived product, an egg-derived product, etc.), a composition
that incorporates teachings of the present invention may include one or
more other ingredients, including, but not limited to, vitamins, minerals,
proteins, natural products (e.g., herbs, mushrooms, roots, etc., or
extracts thereof, and the like. Additional ingredients may be useful for
providing further advantages to subjects to which the composition is
administered, or may enhance the ability of the transfer factor in the
composition to elicit or enhance a secondary, or delayed-type
hypersensitivity, immune response.
As shown in FIG. 1, without limiting the scope of the present invention, a
composition 10 according to the present invention may take the form of a
powdered or particulate substance, which includes the multiple types of
transfer factor (not shown). In order to ensure that an appropriate and
precise dosage of composition 10 is administered to a subject (not shown),
composition 10 may be contained within a gelatin capsule 12 of a type
which is well-known and readily available to those in the art. The result
is the illustrated capsule 14. Alternatively, a composition according to
the present invention may be embodied as tablet, a so-called "caplet," an
unencapsulated powder, a liquid, a gel, or in any other pharmaceutically
acceptable form. Suitable processes for placing the inventive composition
into any such form are readily apparent to those of skill in the art.
In an exemplary embodiment of a method for making or forming a composition
according to the present invention, a first type of transfer factor may be
combined with a second type of transfer factor. Additionally, one or more
other types of transfer factor may be combined with the first and second
types of transfer factor. The different types of transfer factor that are
combined may be substantially purified transfer factor, components or
"products" that include transfer factor, or any combination thereof.
Turning again to FIG. 2, a process for forming composition-filled capsules
14, such as that shown in FIG. 1, is provided merely as an example for a
method for making a composition that incorporates teachings of the present
invention. As illustrated, the composition 10 is made and
composition-filled capsules 14 are formed using standard capsulation
equipment 20 of a type known in the industry, such as the SF-135
capsule-filling machine available from CapPlus Technologies of Phoenix,
Ariz.
In addition to one or more composition supply hoppers 24, an auger 26
associated with each composition supply hopper 24, and a feed station 28
with which each auger 26 and the conduit 27 within which auger 26 is
contained communicates, capsulation equipment 20 includes one or more
capsule hoppers 30, as well as a pneumatic feed system 32 for transporting
capsule bodies 12a and/or caps 12b to feed station 28.
As the capsulation equipment will introduce the mixture into capsules,
which may be swallowed by a subject, it is currently preferred that the
substantially fat-free component and the egg-derived product be introduced
into the capsulation equipment in powdered form. The substantially
fat-free component dilutes the amount, or concentration, of fat (e.g.,
from egg yolk) present in the mixture relative to the concentration of fat
which is present in the egg-derived product. Accordingly, the relative
amounts of the substantially fat-free product and the egg-derived product
may be tailored to provide a fat concentration that will minimize clogging
of the capsulation equipment.
Continuing with the example of a composition 10 which includes a
colostrum-derived product 10a as the substantially fat-free component and
an egg-derived product 10b, colostrum-derived product 10a and egg-derived
product 10b may be introduced simultaneously into a single composition
supply hopper 24 of capsulation equipment 20. For example,
colostrum-derived product 10a and egg-derived product 10b may be mixed
upon introduction thereof into composition supply hopper 24, as shown, or
premixed. By introducing a substance which has a lower fat content than
egg-derived product 10b into composition supply hopper 24 along with
egg-derived product 10b, the fat content (e.g., concentration) of the
resulting mixture is less than that of egg-derived product 10b, reducing
or eliminating the likelihood that composition supply hopper 24, auger 26,
conduit 27, feed station 28, or any other component of capsulation
equipment 20 will be coated with cholesterol or fat.
Following introduction of a predetermined amount of composition 10 into
capsule bodies 12a at feed station 28, the filled capsule bodies 12a are
transported to a capsule closing station 34, where capsule caps 12b are
assembled therewith to fully contain composition 10 within capsule 12.
Again, a composition-filled capsule 14 is only one example of the manner in
which a composition that incorporates teachings of the present invention
may be embodied. The inventive composition may also take other forms, such
as tablets, caplets, loose powder, liquid, gel, liquid-filled or
gel-filled capsules, or any other pharmaceutically acceptable form known
in the art, each of which may be made by known processes.
The composition of the present invention may be administered to a subject
(e.g., a mammal, such as a human, a dog, or a cat, a bird, a reptile, a
fish, etc.) by any suitable process (e.g., enterally, parenterally, etc.),
depending, of course, upon the form thereof. For example, virtually any
form of the composition (e.g., a capsule, tablet, caplet, powder, liquid,
gel, etc.) may be administered orally (i.e., through the mouth of the
subject), provided that the composition includes a pharmaceutically
acceptable carrier of a type known in the art that will prevent
degradation or destruction of transfer factor molecules by the conditions
that persist in the digestive tract of the subject without substantially
interfering with the efficacy of the transfer factor molecules included in
the composition.
The dosage of composition or transfer factor within the composition that is
administered to the subject may depend on a variety of factors, including,
without limitation, the subject's weight, the health of the subject, or
conditions (e.g., pathogens) to which the subject has been exposed.
Administration of the composition to the subject may cause the immune
system of the subject to elicit a T-cell mediated immune response against
one or more antigens or pathogens. Thus, the composition may be
administered to a subject to treat a disease state that the subject is
experiencing, to prevent the subject from exhibiting a disease state
caused by a particular pathogen, or to merely enhance the overall health
of the subject's immune system and abilities to fight off infecting or
invading pathogens.
The following EXAMPLES illustrate the enhanced ability of a composition
which includes transfer factor from multiple types of source animals to
cause an immune system of a treated subject to elicit a T-cell mediated
immune response to various types of pathogens, in the form of target
cells. The target cells included bacteria (e.g., C. pneumoniae and H.
pylori) and viruses (e.g., herpes simplex virus-1 (HSV-1) and herpes
simplex virus-2 (HSV-2)) in the form of virally infected cells, as well as
to cancerous, or malignant, cells (e.g., K562 erythroleukemic cells).
The in vitro technique that was used to make these determinations was the
so-called "chromium-51 release assay," which includes measurement of the
amount of radioactive chromium-51 (Cr-51) released by cells that have been
attacked by NK cells. The radioactivity measurement may be obtained, for
example, with a Beckman 2000 Gamma Counter, which is available from
Beckman Coulter, Inc., of Fullerton, Calif.
In the EXAMPLES, a fixed amount (5 micrograms per milliliter of nutrient
media and cellular milieu) of a powdered composition was provided in the
nutrient media and cellular milieu, along with a substantially fixed
amount of NK cells. Examples of the powdered compositions that were used
include bleached wheat flour, Transfer Factor.TM. (TF), available from
4Life Research, LLC, of Sandy, Utah, Transfer Factor Plus.TM. (TFP), also
available from 4Life Research, avian transfer factor available in a
lyophilized (ie., freeze-dried) whole egg powder, and mixtures of TF and
TFP (both the formula marketed in the United States and that marketed
internationally) with avian transfer factor in a ratio of about 85% TF or
TFP (ie., bovine transfer factor), by weight, to about 15% avian transfer
factor, by weight. The powdered composition, nutrient media, NK cells, and
target cells were mixed and incubated for four hours prior to measuring
the radioactive atoms that were released by disruption of the target cells
by the NK cells. Each exemplary reaction was conducted in triplicate, with
the results of the three reactions having been averaged.
The following TABLE includes data of the counts per minute obtained with
each combination of target cells and powdered composition, as well as the
effectiveness of each powdered composition in eliciting an NK
cell-mediated immune response against the target cells relative to the NK
cell-mediated immune response relative to (measured in percent increase)
the same types and concentrations of target cells in the presence of
bleached wheat flour.
TABLE
Target Cells
Composition C. Pneu H. Pyl K562 HSV-1 HSV-2
Flour 1323/ 1121/ 1267/ 2017/ 1262/
TF 2593/ 2499/ 2445/ 2240/ 2473/
% increase 196% 223% 193% 110% 196%
TFP 3386/ 2701/ 3243/ 2944/ 1956/
% increase 256% 241% 256% 146% 155%
100% 2553/ 1860/ 2483/ 2985/ 2183/
Avian TF
% increase 193% 166% 196% 148% 173%
Bov-Av TF 14,857/ 11,434/ 6,639/ 17,910/ 10,626/
% increase 1123% 1020% 524% 888% 842%
Bov-Av 61,956/ 55,432/ 40,075/ 80,498/ 46,933/
TFP US
% increase 4683% 4944% 3163% 3991% 3719%
Bov-Av 57,471/ 47,855/ 36,401/ 73,660/ 42,693/
TFP Intl
% increase 4344% 4267% 2873% 3652% 3383%
The results that are set forth in the TABLE show that administration of a
composition of the present invention to a subject will likely increase the
subject's secondary, or delayed-type hypersensitivity, immune response, as
effected by NK cells, against one or more pathogens to a degree which far
exceeds the NK cell activity initiated by both colostrum-derived transfer
factor and egg-derived transfer factor alone. In fact, the results show
that a composition that incorporates teachings of the present invention
may result in facilitation of the activity of NK cells with an unexpected
degree of synergy.
Although the foregoing description contains many specifics, these should
not be construed as limiting the scope of the present invention, but
merely as providing illustrations of some of the presently preferred
embodiments. Similarly, other embodiments may be devised without departing
from the spirit or scope of the present invention. Features from different
embodiments may be employed in combination. The scope of the invention is,
therefore, indicated and limited only by the appended claims and their
legal equivalents rather than by the foregoing description. All additions,
deletion and modifications to the invention as disclosed herein which fall
within the meaning and scope of the claims are to be embraced thereby.
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