Note: Descriptions are shown in the official language in which they were submitted.
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ANTI-CANCER AGENTS DERIVED FROM
FERTT~ T7.Fn INCUBATED SHELL EGGS
5 FIELD OF THE INVENTION
The present invention relates to the use of fertilized incubated shell
eggs in the treatment and prevention of cancer, and to compositions
comprising such eggs or extracts thereof.
10 BACKGROUND OF THE INVENTION
The toxic effects of conventional cancer treatments such as
chemotherapy and radiation are well known. Frequently, patients in the end
stages of cancer are too weak to withstand the toxicity of such treatments,
thus limiting treatment options for such patients.
Therefore, the disadvantage exists that the toxicity of conventional
cancer treatments limits their efficacy.
SUMMARY OF THE INVENTION
Fertilized eggs, and even fertilized partially incubated eggs, have been
20 used in the past as a foodstuff. It is also known that fertilized incubated shell
eggs have libido or testosterone enhancing properties and are therefore used
to treat disorders of sexual function.
However, the inventor has surprisingly found that fertilized incubated
shell eggs have anti-cancer activity and may be used in the prevention and
25 treatment of cancer. Compositions according to the present invention
cont~inin~ fertilized incubated shell eggs are non-toxic and may be used in
combination with other cancer treatments such as radiation and/or
chemotherapy. Compositions according to the present invention are
particularly useful in the treatment of end stage cancer, and in cases where
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conventional treatments such as radiation and chemotherapy have failed.
One object of the present invention is to provide a method of treatment
of the human or non-human m~mm~ n body to treat or prevent cancer, said
method comprising ~dmini~tering to said body a therapeutic agent derived
5 from fertilized, incubated shell eggs.
Another object of the present invention is to provide the use of
fertilized incubated shell eggs for the manufacture of an agent for use in
treatment of cancer in a human or non-human m~mm~ n body.
Yet another object of the present invention is to provide the use of
10 fertilized incubated shell eggs for the manufacture of an agent for use in
prevention of cancer in a human or non-human m~mm~ n body.
Yet another object of the present invention is to provide a novel
therapeutic composition comprising an amount of dried fertilized incubated
shell eggs or a component thereof effective to treat or prevent cancer,
15 optionally together with one or more physiologically tolerable carriers or
excipients.
Yet another object of the present invention is to provide a process for
the preparation of an anti-cancer agent, the process comprising incubating
fertilized shell eggs into the blastodermal to protoembryonic stage (e.g. for
20 2 to 15, preferably about 10 days in the case of hens eggs) and freeze dryingthe shell contents or a component thereof having anti-cancer activity, for
example the yoLk from which the surrolln~lin~ albumin has been removed.
In one aspect, the present invention provides a composition,
comprising: an amount of an egg product effective to prevent or treat cancer,
25 the egg product being selected from the group comprising dried fertilized
incubated shell egg and components thereof; and one or more physiologically
tolerable carriers or excipients.
In another aspect, the present invention provides the use of fertilized
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incubated shell egg to treat or prevent cancer in a m~mm~l.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The inventor has found that anti-cancer action is possessed by
5 fertilized and incubated eggs, whereas unfertilized and/or unincubated eggs
do not appear to have this activity. Although the reason for the anti-cancer
activity of fertilized incubated shell eggs is not clear, it is believed to result
from the production of active factors in the transformation of the egg yolk
during embryogenesis.
By a shell egg is meant an ~nim~l egg having an opaque shell,
preferably a bird or reptile egg. More preferably, the shell eggs used in the
present invention are avian eggs, especially those from birds bred for egg
production, for example hens, geese, ducks, quail, turkeys, ostriches,
phe~nt~, pigeons and the like. Mostpreferably, the shell eggs used in the
15 present invention are hens' eggs.
Eggs produced for human consumption are typically either unfertilized
or majoritively unfertilized. Fertilized eggs which may inadvertently be
presented for human consumption are generally unincubated eggs or eggs
which have been incubated only for 1 or 2 days.
The eggs used according to the invention are preferably in the
blastodermal and subsequent preembryonic to protoembryonic stages in which
yolk transformation has begun, but the organs of the embryo are barely if at
all discernible. This corresponds essentially to the subembryonic liquid stage
of embryogenesis, generally 3 to 14 days incubation for a hen's egg, or the
25 period up to the acceleration of calcium uptake by the embryo, which
typically occurs after about 15 days incubation for the hen's egg.
In the case of fertilized hens' eggs used according to the invention, the
incubation period is preferably up to about 15 days, for example 2 to 15
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days, more preferably about 3 to 12 days, particularly preferably about 5 to
10 days, and most preferably about 8, 9 or 10 days. Eggs incubated for such
periods would generally be considered unfit for human consumption due to
the degree of transformation of the yolk that has occurred and, for the upper
5 limit, due to the presence of an embryo with visible organs.
Although the eggs used in the present invention are preferably in the
subembryonic liquid stage of embryogenesis, in which the organs of the
embryo are not clearly discernible, this is not necessarily the case. For
example, eggs in which the embryo is has at least partially developed or is
10 ready to hatch may also be used according to the present invention.
Examples of such eggs include hen or duck eggs which have been incubated
for greater than 15 days, preferably about 18 days.
Therapeutic agents according to the present invention may be
s~lmini~tered to humans and other m~mm~l~ by a variety of methods, for
15 example into the gastrointestinal tract (rectally or more preferably orally) or
by injection.
For oral ~lmini~tration according to the present invention, it is of
course feasible to ~(lmini~ter the egg contents without any extensive
preparation, for example the whole egg or egg yolk whisked into a glass of
20 milk.
However, it is preferred that fertilized, incubated eggs for
gastrointestinal ~-lmini.~tration be in freeze dried form. Freeze dried egg is
easily mixed with other ingredients to form a composition and has a shelf life
which facilitates manufacture, pack~in~, transport and storage of
25 compositions according to the invention.
The dried egg may be prepared for example by freeze drying the whole
uncooked contents from within the egg shell. Alternatively, the contents may
be divided to remove some or all of the albumin and if desired some or all
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of the macroscopic structures within and surro~ln~lin~ the yolk, for example
membranes, blood vessels and embryo. Nevertheless, for general ease of
preparation, either the entire shell content or the yolk fraction of such
contents divided physically into yolk and albumin, for example by pouring
5 off the albumin, are preferably used to produce the compositions of the
invention.
The freeze dried product produced in this way is low in cholesterol
and, as long as the eggs' surfaces are sterilized before removal of the
contents there should be no health concerns relating to the ingestion of the
10 product. Nonetheless, the eggs preferably derive from a salmonella free
flock and thus fertilized hens eggs deriving from Norway, Sweden, Finland,
New 7e~1~n~1 and Malta are particularly preferred.
Compositions of the present invention for gastrointestinal
~clmini~tration are preferably in pulverulent form and optionally include other
15 components serving for example to enhance or mask flavour or to facilitate
dispersion of the egg powder in an aqueous fluid for oral ~lmini~tration.
The compositions can however contain conventional pharmaceutical carriers
or excipients and may be presented in standard ~lmini~tration forms for oral
or rectal ~-lmini~tration, for example powders, tablets, coated tablets,
20 capsules, suppositories, etc.
Examples of preferred additives include the vitamins and minerals of
conventional daily food supplement compositions, sweeteners such as
saccharides, carotenes, folic acid, citrates, plant flavourings such as ginseng,vitamin Bl2, vitamin Bl (e.g. t~i~mine), vitamin C, vitamin E
2s (e.g. c~-tocopherol)"~-carotene, folic acid, glucose, fructose, sodium and
potassium citrates, gelatin, glycerine, silica (silicon dioxide), silicium
dioxide, magnesium chloride, zinc oxide, and extracts, oils or powders
derived from ginseng, aniseed, rosemary, peppermint, hops, camomile,
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thyme, clove and fennel.
The egg powder preferably is present in the above compositions at
about 30 to 90% by weight, preferably about 70 to 80% by weight, more
preferably about 75 % by weight of the composition.
In another preferred embodiment of the present invention, compositions
are provided cont~inin~ fertilized incubated egg in amounts greater than 90%
by weight, including fertilized incubated egg in pure or substantially pure
form. The fertilized incubated egg used in these preferred forms may be
prepared using either the entire shell content of fertilized eggs or the yoL~
10 fraction only.
More preferably, the present invention provides compositions
cont~inin~ fertilized incubated egg in amounts greater than 95% by weight,
and most preferably greater than about 96% by weight. Such compositions
may contain any of the additives which may be used in compositions
15 cont~inin~ egg powder in the range of 30 to 90% by weight. However, these
compositions preferably contain little or no flavour enhancing ingredients,
and most preferably do not contain any flavour enhancing ingredients.
One particularly preferred composition for gastrointestinal
~dmini~tration according to this embodiment comprises about 96% by weight
20 fertilized incubated egg powder and contains as additives potassium citrate,
sodium citrate, tx-tocopherol, silicon dioxide, gelatin and glycerine. Such a
composition is preferably in the form of a powder, tablet, coated tablet,
capsule, suppository, or any other convenient form, most preferably a
capsule, each capsule preferably cont~inin~ about 450 mg of composition.
Furthermore, the fertilized incubated egg according to the present
invention may be gastrointestinally ~dmini~tered in pure form without any
additives. In this case, the fertilized incubated egg may be in any convenient
form, including the forms mentioned above.
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In another preferred embodiment, the present invention provides food
and beverage products for oral ~-lmini~tration cont~ining fertilized incubated
egg. The fertilized incubated egg may be present in such food and beverage
products either in pure form or in the form of a composition. The inventor
5 has found the fertilized incubated egg, particularly in powder form, to be
inert and stable, both in pure form and in the form the compositions
disclosed herein. Therefore, the fertilized incubated egg of the present
invention may be added to a wide range of food and beverage products, thus
providing the benefits of fertilized incubated egg in a convenient and pleasant
10 tasting form.
For example, the fertilized incubated egg may preferably be presented
in a convenient snack food form to be consumed at least once a day. Such
snack foods include chocolate bars, candy bars, energy bars and granola
bars. The addition of small amounts of fertilized incubated egg to foods, for
15 example on the order of from about 3 to about 5 g, would not subst~nti~lly
affect their taste.
The fertilized incubated egg may also be incorporated into a wide
range of other food products which may be consumed hot or cold.
Alternatively, the fertilized incubate egg in pure form or in the form of a
20 composition may be packaged in powdered or any other convenient form for
use as a food additive, the user ~ lin~ measured amounts of the additive to
his or her meals.
Preferred beverage products cont~inin~ the fertilized incubated egg of
the present invention include ready to consume beverage products and
25 beverage concentrates in liquid and solid form to be mixed with water. Most
preferred beverage products include milk shake type drinks, energy drinks,
mineral replacement drinks as used by athletes, juices, and flavoured crystals
or powder to be mixed with water. As with food products, a small,
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measured, amount of fertilized incubated egg powder, for example 3 to 5 g,
would not subst~nti~lly affect the flavour of the beverage product.
As mentioned above, the present invention also includes within its
scope injectable compositions cont~inin~ fertilized incubated eggs. As in the
5 case of gastrointestinally ~dmini~tered compositions, injectable compositions
may be prepared in which the egg contents are used directly without
extensive preparation. For example, one injectable composition of the
present invention is prepared by breaking open a fertilized hen's egg which
has been incubated for 8 or 9 days and ~ddin~ up to about 0.5 chlorbutanol
10 to the egg contents as a preservative. The resulting mixture is then boiled
and filtered to yield an injectable composition.
It is to be appreciated that numerous other injectable compositions may
also be prepared, for example from freeze dried fertilized incubated eggs as
discussed above. The injectable compositions according to the present
15 invention may also comprise pharmaceutically acceptable additives and
carriers, including some of those listed above.
In one preferred embodiment of the present invention, fertilized
incubated egg in any of the forms described above is ~lmini.stered to a
patient concurrently with a high vitamin diet and/or a vitamin supplemented
20 diet. The diet preferably includes subst~nti~l amounts of raw fruits and
vegetables, wheat germ, vegetable juices and milk. Vitamin supplements
preferably include a vitamin B complex.
The compositions according to the present invention are preferably
~dmini~tered to cancer patients having malignant tumours which may or may
25 not have formed secondary (metastatic) growths in other parts of the body via the blood or lymph system. One major advantage of the compositions of
the present invention is that they are non-toxic in comparison to conventional
treatments such as surgery, chemotherapy and radiation. This permits the
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compositions of the present invention to be used in combination with
conventional forms of treatment without the danger of further weakening the
patient. Furthermore, treatment with the compositions may continue for an
extended period of time at relatively high doses without c~ in a toxic
5 reaction in the patient. The compositions of the present invention may also
be used in patients in the end stages of cancer who may be too frail to endure
further treatment by conventional means, or for whom conventional
treatments would provide no further benefit.
Although the compositions of the present invention are subst~n~i~lly
10 non-toxic, caution must be exercised in ~lmini~tering the compositions due
to the risk of allergic reactions in patients having egg allergies.
Due to the non-toxicity of the compositions of the present invention,
patients may preferably be treated with large doses of the compositions for
an extended period of time. Preferred doses comprise the equivalent of from
15 about 10 to about 50 fertilized incubated eggs per day, more preferably from
about 15 to about 35 fertilized incubated eggs per day, and most preferably
from about 20 to 30 fertilized incubated eggs per day. In some cases, the
dosage may be limited to avoid causing an allergic reaction in a patient.
Treatment for a period of about two months is typically required before
20 patients experience a noticeable decrease in the number and size of tumours.
Once treatment has commenced, it is preferably continued for an indefinite
period. Even after total disappearance of tumours, it is preferred that
treatment be continued in order to prevent the cancer from returning.
Although the compositions of the present invention are preferably used
25 to treat patients having cancerous tumours, it is to be appreciated that the
compositions may also be used on a preventative basis in healthy persons
who have never had cancer or in persons whose cancers have been
successfully treated.
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Although the compositions of the present invention have been described
above as being useful for treating cancer in humans, it is to be understood
that the compositions may be used to treat cancer in non-human ~nim~
preferably m~mm~
Although the invention has been described in connection with certain
preferred embodiments, it is not intended to be limited thereto. Rather, it is
intended that the invention cover all alternate embodiments as may be within
the scope of the following claims. The invention also includes all
embodiments which are functional or mechanical equivalents of the specific
10 embodiments and features that have been described herein.
It will be further understood that, although various features of the
invention have been described with respect to one or another of the
embodiments of the invention, the various features and embodiments of the
invention may be combined or used in conjunction with other features and
15 embodiments of the invention as described herein.
