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Title:  Method for treatment of lyme disease

United States Patent:  6,592,875

Issued:  July 15, 2003

Inventors:  McMichael; John (Delanson, NY)

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

Appl. No.:  556715

Filed:  April 21, 2000

Abstract

The present invention relates to a treatment for patients having Lyme disease by administering a composition comprising an Borrelia burgdorferi antigen at a sub-vaccine level effective to alleviate symptoms of Lyme disease.

SUMMARY OF THE INVENTION

The invention provides methods for treating a patient suffering from Lyme disease comprising the step of: administering a composition comprising a Borrelia burgdorferi antigen at a sub-vaccine level effective to alleviate symptoms of Lyme disease. Suitable antigens for use according to the invention include outer surface lipoproteins of Borrelia burgdorferi such as the outer surface lipoproteins OspA, OspB, OspC and the antigen LFA-a. A preferred antigen for use according to the invention is lysed Borrelia burgdorferi produced by treatment of the organism in phenol followed by multiple freeze/thaw cycles. Borrelia burgdorferi for use according to the invention is publically available as ATCC deposit 35210.

The Borrelia burgdorferi antigens are administered at sub-vaccine levels. Sub-vaccine levels are defined as levels less than those sufficient to induce an effective humoral immune response as exemplified by the determination of a positive wheal upon subcutaneous injection. According to one aspect of the invention, the composition comprises from about 0.5x10-6 g to about 0.02x10-6 g of the outer surface lipoprotein per dose and from one to four doses are administered daily. More preferably, the composition is administered at a dosage of about 0.1x10-6 g of the outer surface lipoprotein. The compositions of the invention may be administered to patients by a variety of suitable methods with means selected from the group consisting of sublingual, subcutaneous, intravenous, intramuscular, and intrathecal administration being preferred. Particularly preferred methods of administration are sublingual and subcutaneous methods of administration. When the composition is administered sublingually, it is preferred that four doses be administered daily. When the composition is administered by injection such as subcutaneously, it is preferred that it be administered in a single daily dose.

According to one preferred method the composition is administered to a patient in a single dose of about 0.05 cc in a pharmaceutically acceptable carrier. Such pharmaceutically-acceptable carriers include water, saline, albumin, and dextrose and combinations thereof.

Compositions of the invention for treatment of the symptoms of Lyme disease comprise Borrelia burgdorferi antigens at a sub-vaccine level effective to alleviate symptoms of Lyme disease in a pharmaceutically acceptable carrier. Preferred are compositions which comprise from about 0.5x10-6 g to about 0.02x10-6 g of the Borrelia burgdorferi per dose with those comprising about 0.1x10-6 g of the Borrelia burgdorferi per dose being most preferred.

Additional aspects and advantages of the invention will become apparent upon consideration of the following detailed description thereof.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to the discovery that the administration of Borrelia burgdorferi antigens at a sub-vaccine levels is effective to alleviate symptoms of Lyme disease. While not wishing to be bound by a particular theory of invention, it is believed that many of the symptoms of Lyme Disease result as a consequence of a hypersensitivity reaction to Borrelia burgdorferi that becomes an auto-immune disorder. The therapy of the invention functions to interrupt the hypersensitivity reaction by inducing suppressor T cells that shut down effector cells (helper T cells, mast cells and killer T cells) that promote the auto-immune response.

The following Examples illustrate the preferred embodiments of the invention and provide evidence of the effectiveness of claimed treatment methods. In addition to the patients described in Examples 1 and 2 about four other patients suffering from Lyme disease have been treated and shown similar results with no adverse side effects. Numerous improvements and further aspects of the invention are apparent to the skilled artisan upon consideration of the Examples which follow.

EXAMPLE 1

According to this example, a 45 year old female suffering from chronic Lyme disease of nearly one year's duration was treated according to the methods of the invention. Previous treatment with antibiotics, steroids, and other analgesics provided only temporary relief from symptoms of arthritis. The patient who was treated by sublingual administration four times daily of one drop (0.05 mL) of a composition comprising a 1:25 dilution of a commercially available recombinant OspA Lyme disease vaccine (LYMErix.TM., SmithKline Beecham Biologicals). The diluted composition comprises 0.12x10-6 g of recombinant lipoprotein OspA adsorbed onto aluminum as aluminum hydroxide adjuvant in phosphate buffered saline further comprising 2-phenoxyethanol as a bacteriostatic agent.

After two weeks treatment according to the method of the invention the subject was nearly pain free, and was able to remain active all day and generally experienced a much improved quality of life. The patient has not experienced any adverse effects.

EXAMPLE 2

According to this example, a 71 year old female with chronic Lyme disease was treated according to the methods of the invention. The patient suffered from nearly incapacitating pain which was refractory to other medications was treated by sublingual administration of four times daily of from three to seven drops (0.05 mL per drop) of the composition of Example 1. The patient showed dramatic improvement in her symptoms after one month and has not experienced any adverse effects.

The invention has been described in terms of its preferred embodiments and is only intended to be limited-by the scope of the following claims.

Claim 1 of 6 Claims

What is claimed:

1. A method for treating a patient suffering from Lyme disease comprising the step of:

administering a composition comprising a Borrelia burgdorferi antigen effective to alleviate symptoms of Lyme disease,

wherein said composition comprises from 0.5x10-6 g to 0.02x10-6 g of Borrelia burgdorferi outer surface lipoprotein per dose.




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If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

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