UUSIA HOITOMUOTOJA - VIIMEISIMMÄT PATENTTIHAKEMUKSET

[Bb]

Lähettäjä: Soijuv Lähetetty: 19.4.2004 9:24

Seuraavassa on esitetty kaksi borrelioosin hoitoon haettua viimeaikaista patenttihakemusta:

1) Dontan hakemus

Hänen mukaansa borrelioosin oireet aiheuttaa suureksi osaksi toksiini Bbtox1 . Kehitetty menetelmä auttaisi sekä borrelioosin diagnosoinnissa että sen hoidossa.


Title: Prevention, diagnosis and treatment of lyme disease

United States Patent: 6,667,038

Issued: December 23, 2003

Inventors: Donta; Sam T. (Boston, MA); Cartwright; Mark J. (West Newton, MA)

Assignee: Boston Medical Center Corp. (Boston, MA)

Appl. No.: 553863

Filed: April 20, 2000

Abstract

The present invention provides compositions and methods related to Borrelia burgdorferi toxin and antitoxin preparations. In particular, the present invention provides methods and compositions for the diagnosis of Lyme disease, as well as for use in treating subjects infected with B. burgdorferi through passive immunization, and vaccine development.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides compositions and methods related to Borrelia burgdorferi toxins. In particular, the present invention provides methods and compositions for the diagnosis, treatment and prevention of Lyme disease and/or Syphilis.

The present invention provides significant advantages and improvements over existing methods, devices, and materials related to Lyme disease. For example, as indicated above, the diagnosis of Lyme disease is often hampered by the absence of reliable tests. In addition, after initial skin infection, cultures for B. burgdorferi are rarely positive. PCR-DNA tests for OspA and other gene determinants are also rarely positive with blood, urine and spinal fluid. Furthermore, serologic tests are generally unreliable (Donta, et al., Clin. Infect. Dis., 25:552-555 (1997)). ELISA and Western blot immunoanalyses are likewise unreliable indicators of current or past infection. Thus, new tests, such as those of the present invention provide important methods and compositions for improving the diagnostic accuracy, treatment, and prevention of Lyme disease.

The compositions and methods of the present invention provide means to prevent Lyme disease through vaccine development and utilization, as well as diagnose Lyme disease in subjects suspected of being exposed to B. burgdorferi. In particular, the present invention provides the full-length sequence of a B. burgdorferi toxin, a toxin that has not been previously identified. While an understanding of the mechanism is not necessary in order to make or use the present invention, it is contemplated that this toxin may play a role in the pathogenesis of Lyme disease. Furthermore, the isolation and purification of the toxin provides methods and compositions for preventing Lyme disease through passive antibody therapy. For example, it is contemplated that the Bbtox1 of the present invention will find use in development of antitoxins suitable for use in approaches to treat Lyme disease.

http://www.pharmcast.com/Patents100/Yr2 ... 122303.htm Koko patenttihakemus

2) Steeren hakemus (huom. jopa Steere näyttää nyt hyväksyvän kroonisen borrelioosin olemassaolon - taloudelliset intressit tekevät ihmeitä)

Steeren hoitona on borrelioosirokote. Kyseinen rokote on subkutaanisti annettuna aiheuttanut borrelioosin joillekin ihmisille ja siksi se vedettiin aikanaan pois markkinoilta. Ehkäpä tämä on parempi versio aiemmista - toivotaan niin.


United States Patent 6,592,875
McMichael July 15, 2003

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 0.5.times.10.sup.-6 g to 0.02.times.10.sup.-6 g of Borrelia burgdorferi outer surface lipoprotein per dose.

2. The method of claim 1 wherein said composition is administered to a patient in a single dose of about 0.05 cc in a pharmaceutically acceptable carrier.

3. The method of claim 1 wherein multiple daily doses of said composition are administered to the patient.

4. The method of claim 1 where the composition is administered to a patient by a means selected from the group consisting of sublingually, subcutaneously, intravenously, intramuscularly, and intrathecally.

5. The method of claim 4, wherein the composition is administered to a patient sublingually.

6. A composition for treatment of the symptoms of Lyme disease comprising a Borrelia burgdorferi antigen effective to alleviate symptoms of Lyme disease in a pharmaceutically acceptable carrier,

wherein the composition comprises from 0.5.times.10.sup.-6 g to 0.02.times.10.sup.-6 g of Borrelia burgdorferi outer surface lipoprotein per dose.

Potilastapaus:

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 0.12.times.10.sup.-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.