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Subject:
From:
"Valerie W, McClain" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Fri, 7 Nov 2003 06:33:14 EST
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Elaine,
Thank you for the welcome!

I thought I'd post on a patent called "Useful properties of human lactoferrin
and varients thereof."  It is of major interest to me how many patents there
are that state that a particular human milk component inactivates hiv/aids
(usually the components are lactoferrin or HMFG(human milk fat globule).  The
assignee to this patent is Pharming of the Netherlands (also in USA) and the
patent # is 6333311. One of Pharming's products is recombinant human lactoferrin.
I believe it is made through transgenics (the human lactoferrin gene is
inserted into a cow embryo).  Trangenics is not allowed in the Netherlands.  But
this company at one time (maybe still) owned herds in Finland.  According to the
Pharming website (www.pharming.com), Royal Numico (infant formula company)
collaborates with Pharming and this site mentions that lactoferrin is already
GRAS in the USA.(very true, milk lactoferrin has FDA GRAS)  Thus here is another
infant formula company using variants of human lactoferrin (Nestle of Japan is
another).  And once again this same patents are stating that human
lactoferrin inactivates hiv/aids.  Yet breastfeeding is discouraged because of hiv/aids.
 This particular patent states that it stops the retrovirus from
attaching--prevention.  Yet, we have policies that believe absolutely that it is a
dangerous thing to breastfeed when a mother is hiv positive.  So "our" human milk
component has been taken, "stolen, " we cannot use it (some hiv-positive women in
the USA face the threat of social services stepping in and taking away their
rights as parents if they plan to breastfeed).  Our competition now has our
component, will use it in their product, and sell it based on its ability to
prevent hiv/aids transmission.  Legally, patents confere the right to sell, the
right to use, and the right to exclude.  Very simply, we are being excluded,
yet we are the "owners."  Our property is being sold right from under us.  We
are the gold mine and they are the claim jumpers.  Notice the claims in this
patent about iron-deficiency in premies--lactoferrin will resolve that problem.
Valerie W. McClain, IBCLC

"Administration of human lactoferrin or a lactoferrin variants to a patient
is useful for stimulating natural killer (NK) cells in the patient. Because hLF
and lactoferrin variants cause stimulation of natural killer (NK) cells, the
LF variants are useful for combating the targets of NK cells, e.g., tumors,
viruses and intracellular pathogens. Stimulation of natural killer (NK) cells by
lactoferrin has been shown in vitro (Shau et al., 1992, J. Leukoc. Biol.
51:343-349) and in vivo (Bezault et al., 1994, Cancer Res. 54:2310-2312). NK cells
can be stimulated in a patient by administering to the patient a composition
comprising a human lactoferrin variant and a pharmaceutical excipient. Human
LF and variants may also be administered to a patient to inhibit growth of a
solid tumor. A single intraperitoneal injection of LF inhibited growth of solid
tumors induced by subcutaneous injection of syngeneic fibroblast-derived tumor
cell lines in mice (Bezault et al., supra). LF variants will thus be useful
for stimulation of NK cells without neutralization of heparin or other
undesirable effects.

The invention also provides methods for inhibiting entry into a cell of
viruses, for example, CMV (cytomegalovirus), HIV (human immunodeficiency viruses)
or HSV1 (herpes simplex virus 1) viruses comprising administering hLF or a
variant to a patient. The antiviral action is mediated by (i) interaction of hLF
with cell surface proteoglycans (e.g., heparin) employed by viral particles for
cell entry, and (ii) by the stimulation of NK cells by hLF and LF variants.

In another aspect, the invention provides a method for delivering iron to a
lactoferrin-receptor-bearing cell in a patient by administering to the patient
a composition of human lactoferrin or a lactoferrin variant which is at least
about 95% saturated with iron. Administration of these compounds are
beneficial, for example, in treatment of anemia or iron storage diseases. LF- or
LF-variant bound iron is delivered to a cell when the polypeptide-iron complex binds
to a cell receptor and is internalized by the cell. Thus the compositions
disclosed herein are suitable for use in baby formula as well as for
administration to patients with disturbances in iron metabolism (e.g., ferriprive anemia
and iron storage diseases, and iron deficiency anemia of premature infants). LF
variants may be saturated with iron following the procedure described in van
Berkel et al., 1995, Biochem J. 312, 107-114. A lactoferrin variant
composition of the present invention will typically be at least 3% saturated with iron,
more usually 80% saturated, most often at least 95% saturated and often more
than 99% saturated. LF variants lacking the first basic cluster, or both the
first and second basic clusters are particularly useful when the iron binding
activities of LF are desired and when the activities mediated by basic clusters
1 and 2 (e.g., heparin binding, high affinity receptor interaction) are not
desired."


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