Title:  Methods for treating disease states comprising administration of low levels of antibodies

United States Patent:  6,294,171

Assignee:  Milkhaus Laboratory, Inc. (Delanson, NY)

Filed:  January 31, 2001

The invention provides methods and compositions for treating the symptoms of disease states associated with the presence of a toxin or infectious agent having the step of administering an antibody specific for the toxin or infectious agent at a dosage of less than 0.1 mg per day.

SUMMARY OF THE INVENTION

The present invention is directed to the discovery that the symptoms of disease states associated with the presence of a toxin or infectious agent may be effectively treated by administration of very low levels of antibodies specific for the toxin or infectious agent. The levels of antibodies admninistered are substantially lower than those traditionally administered to directly neutralize target antigens and for example are typically less than 0.1 mg of antibody per day. Specifically, the antibodies may be administered in one or in multiple dosages but the sum of antibodies administered in any 24 hour period is less than 0.1 mg.

While the antibody may be monoclonal or polyclonal, it is preferably monoclonal according to one aspect of the invention. The antibody may be admninistered by a variety of manners but is preferably administered enterically and most preferably orally. Suitable methods of oral administration include oral drench and sublingual administration. According to another preferred aspect of the invention the antibody is administered in an enterically protected form. In addition, the antibodies of the invention may be administered by injection such as by subcutaneous injection.

The symptoms of various disease states can be treated according to the invention including those of various central nervous disorders including autism, multiple sclerosis, attention deficit disorder (ADD), and attention deficit hyperactivity disorder (ADHD), all of which can be treated by administration of very low levels of anti-rubeola antibody. Dosages of antibodies administered according to the invention including anti-rubeola antibodies range from 1x10^-10 to a 1x10^-1 mg/dosage with dosages of from 1x10^-5 to 1x10^-4 mg (e.g. 8x10^-5 mg) and dosages of from 2x10^-5 to 2x10^-3 mg being preferred.

The invention also provides treatment of the symptoms of pulmonary infection by administering an effective amount of anti-Mycoplasma pneumonia antibody with daily dosages of less than 0.1 mg being preferred and daily dosages ranging from 1x10^-5 to 1x10^-3 mg/day being particularly preferred.

The invention also provides treatment of symptoms of Alzheimer's Disease by administering an effective amount of anti-amyloid beta antibodies with daily dosages of less than 0.1 mg being preferred and daily dosages ranging from 1x10^-5 to 1x10³1 3 being particularly preferred.

According to a further aspect of the invention it has been discovered that administration of anti-rubeola antibodies can be effective in the treatment of symptoms of Crohn's Disease. Accordingly, the invention provides a method of treating the symptoms of Crohn's Disease comprising administering an effective amount of anti-rubeola antibody. Preferred dosages are less than 0.1 mg antibody daily with daily dosages ranging from 2x10^-5 to 2x10^-3 mg being particularly preferred.

According to a further aspect of the invention it has been discovered that the administration of anti-Klebsiella pneumnonia antibodies can be useful for the treatment of rheumatoid arthritis and specifically for juvenile rheumatoid arthritis. Preferred dosages are less than 0.1 mg of anti-Klebsiella pneumonia antibody daily with daily dosages ranging from 1x10^-4 to 1x10^-3 mg/day (e.g. 4x10^-4 mg/day) being particularly preferred.

The invention also provides methods for treating the symptoms of diabetes comprising the method of administering an effective amount of antibody directed against glutamnic acid decarboxylase. Preferred dosages are less than 0.1 mg of anti-glutamic acid decarboxylase antibody daily with daily dosages ranging from 1x10^-4 to 1x10^-3 mg/day (e.g. 4x10^-4 mg/day) being particularly preferred.

The invention also provides pharmaceutical compositions for administration to subjects for treatment of the symptoms of disease states comprising antibody specific for a toxin or infectious agent associated with the disease state in a dosage unit of less than 0.1 mg antibody.

Claim 1 of 33 Claims

What is claimed is:

1. A method of treating the symptoms of a disease state associated with the presence of a toxin or infectious agent comprising the step of administering an antibody specific for said toxin or infectious agent at a dosage of less than 0.1 mg per day.

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