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Subject:
From:
"Valerie W, McClain" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Tue, 2 Dec 2003 14:19:35 EST
Content-Type:
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Thought this patent worth sharing.  Patent # 5505955 called "Anti-diarrheic
product and method of treating rotavirus-associated infection," invented by
Peterson, et al.  The assignees are Senomed, Inc, Cancer Research Fund of Contra
Costa and John Hopkins Univ. of Medicine with the US government declaring it
may have rights because it was funded in part by the NIH and Health Department.
 This product is for use in infant formula and various foods.  Its called
human milk fat globule (HMFG).  It will inhibit the rotavirus infection in
infants and children and HIV positive and transplant patients.  Hurray for the
ingenuity of men who can invent human milk fat globule and save our children and
hiv positive and transplant patients from rotavirus!!
Although the 30 healthy lactating mothers who donated their milk to the
Worcester Milk Bank should be thanked, too!
Valerie W. McClain, IBCLC

"The agent of this invention may be present in the infant formula in an
amount from 0.01 to 99.9 wt %, and more preferably about 0. 1 to 2.0 wt % of the
composition. Other amounts of the agent, however, may also be used. As this
product is formulated for the prophylatic or therapeutic treatment of infants and
children afflicted with or at risk of diarrheal conditions associated with
rotaviral infection, the infant food product may include varying amounts of
infant formula, juices, foods, milk or milk supplements, among others. This
anti-diarrheic infant product may also include vitamin supplements, water, mineral
and other nutritional additives, salts, buffers, flavoring compounds, diluents,
thickeners, emulsifiers, preservatives, encapsulation agents, glycosidase
inhibitors, protease inhibitors, and anti-oxidants, such as would be familiar to a
person skilled in the art. The infant formula may also be modified to include
varying amounts of water and other solutes to meet other clinical needs of
the infant or child, The human milk components of this invention being routinely
consumed and consisting of biological molecules, their administration will
neither require clinical precautions nor medically trained personnel.
Accordingly, the present products may be sold over the counter.

Also part of this invention is a method of retarding the onset of, or
countering, diarrhea associated with rotavirus infection in a subject's cells
comprising administering to a subject in need of such treatment a composition
comprising an anti-rotavirus effective amount of an agent selected from the group
consisting of defatted human milk fat globules, skim milk, the human milk
macromolecular fraction, curd, whey, the human milk mucin-70 Kd app.MW
glycoprotein-46 Kd app.MW glycoprotein complex, the 46 Kd app.MW glycoprotein, a polypeptide
having the rotavirus-binding specificity of the 46 Kd app.MW HMFG
glycoprotein and mixtures thereof, and optionally a pharmaceutically-acceptable carrier
and/or a foodstuff. Because of minimal side effects associated with the agent
used in this method, the agent may also be administered for diarrheal symptoms
regardless of etiology to prevent secondary outbreaks associated with
rotavirus infection.

This invention also provides a method of retarding the onset of, or
countering, diarrhea associated with rotavirus infection in an immunodeficient subject
comprising administering to an immunodeficient subject an anti-rotavirus
effective amount of an agent selected from the group consisting of defatted human
milk fat globules, the human milk macromolecular fraction, skim milk, curd,
whey, the human milk mucin-70 Kd app.MW glycoprotein-46 Kd app.MW glycoprotein
complex, the 46 Kd app.MW glycoprotein, a polypeptide having the
antibody-binding specificity of the about 46 Kd app.MW HMFG glycoprotein, and mixtures
thereof, optionally comprising a pharmaceutically acceptable carrier and/or
foodstuffs as described above. Such immunodeficiencies may result from genetic
dysfunction, organ transplant, disease induced conditions or as a consequence of
medical treatment with drugs, among others.

Other agents that may be added to the composition for this particular
application are bulking agents, carbon black, high fiber additives, encapsulation
agents, protease inhibitors, glycosidase inhibitors, and carrier lipids,
optionally miceliar, among others. These may be present in amounts known in the art.

Specific applications of the above method are in cases of, e.g., transplants
such as bone marrow, kidney, heart and other organ transplants. Transplant
patients receiving immunosuppressant drugs may also benefit from this
anti-diarrheic treatment.

The above preventative and therapeutic methods may be practiced by
administering the agent provided herein as part of an anti-diarrheic composition also
comprising a carrier or a product such as a foodstuff, as described above.
Suitable foodstuffs are milk, juices, cereals, powdered grains, candies,
confections, cookies, meats, vegetables and fruits, put through a blender or otherwise
processed, and crackers, among others.

Having now generally described this invention, the same will be better
understood by reference to certain specific examples, which are included herein for
purposes of illustration only and are not intended to be limiting of the
invention or any embodiment thereof, unless so specified.

EXAMPLES

Example 1

Source of Human Milk

Human milk was obtained from 30 healthy, lactating women donors to the
Central Massachusetts Regional Milk Bank, Worcester, Mass. The donors were chosen to
represent a wide range of maternal ages ranging from 20 to 37 years (average:
28.+-.4 years), parity: 9 primiparous, 13 secundiparous, 5 tertiparous, 3
quadriparous with a 0 to 14 months lactation period (average:6.0 .+-.3.8 months
postpartum). The milk was generally expressed in the morning by means of a
mechanical pump, pooled and used to isolate the human milk components utilized
below. "






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