Passive immunization of ASCR for prion disorders

• US 6,936,246 B1
• Filed: 11/28/2000
• Issued: 08/30/2005
• Est. Priority Date: 12/02/1997
• Status: Expired due to Term

• Current Assignee: Prothena Biosciences Limited
• Original Assignee: Neuralab Ltd. (Perrigo Company PLC)
• Inventors: Schenk, Dale B.
• Primary Examiner(s): Kemmerer, Elizabeth C.
• Assistant Examiner(s): NICHOLS, CHRISTOPHER J
• Application Number:
  US09/724,570
• Time in Patent Office: 1,736 Days
• Field of Search: 424/130.1, 424/135.1, 424/141.1, 424/142.1, 424/178.1, 514/1, 514/2, 514/12, 514/4, 530/300, 530/350
• US Class Current: 424/130.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: A61K 2039/55505 Inorganic adjuvants
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 2039/55572 Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
• CPC Class Codes: A61K 2039/55577 Saponins; Quil A; QS21; ISCOMS
• CPC Class Codes: A61K 2039/6037 Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
• CPC Class Codes: A61K 2039/605 MHC molecules or ligands thereof
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/1709 from mammals
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/0007 Nervous system antigens; Prions
• CPC Class Codes: C07K 14/4711 Alzheimer's disease; Amyloid plaque core protein
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 2317/34 Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C07K 2319/00 Fusion polypeptide
• CPC Class Codes: G01N 2800/2821 Alzheimer
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease

Abstract

Disclosed are pharmaceutical compositions and methods for preventing or treating a number of amyloid diseases, including Alzheimer'"'"'s disease, prion diseases, familial amyloid neuropathies and the like. The pharmaceutical compositions include immunologically reactive amounts of amyloid fibril components, particularly fibril-forming peptides or proteins. Also disclosed are therapeutic compositions and methods which use immune reagents that react with such fibril components.

Claims

1. A method of therapeutically treating a patient suffering from a prion disorder associated with AScr, comprising administering to the patient an effective dosage of a human, chimeric, or humanized antibody or antibody fragment thereof that specifically binds to AScr, wherein the isotype of the antibody is human IgG1, and thereby therapeutically treating the disorder.

2. The method of claim 1, wherein said effective dosage is characterized by a level in the patient of a serum amount of immunoreactivity against AScr that is at least about four times higher than a serum level of immunoreactivity against AScr measured in a pre-treatment control serum sample.

3. The method of claim 1, wherein the antibody or antibody fragment is administered with a carrier as a pharmaceutical composition.

4. The method of claim 1, wherein the antibody or antibody fragment is administered intraperitoneally, orally, subcutaneously, intramuscularly, intranasally, topically, or intravenously.

5. The method of claim 1, wherein the antibody or antibody fragment is administered in multiple dosages over a period of at least six months.

6. The method of claim 1, wherein the antibody or antibody fragment is administered as a sustained release composition.

7. A method of prophylactically treating a susceptible to a prion disorder associated with AScr, comprising administering to the patient an effective dosage of a human, chimeric, or humanized antibody or antibody fragment thereof that specifically binds to AScr, wherein the isotype of the antibody is human IgG1, and thereby effecting prophylaxis of the disorder.

8. The method of claim 7, wherein said effective dosage is characterized by a level in the patient of a serum amount of immunoreactivity against AScr that is at least about four times higher than a serum level of immunoreactivity against AScr measured in a pre-treatment control serum sample.

9. The method of claim 7, wherein the antibody or antibody fragment is administered with a carrier as a pharmaceutical composition.

10. The method of claim 7, wherein the antibody or antibody fragment is administered intraperitoneally, orally, subcutaneously, intramuscularly, intranasally, topically, or intravenously.

11. The method of claim 7, wherein the antibody or antibody fragment is administered in multiple dosages over a period of at least six months.

12. The method of claim 7, wherein the antibody or antibody fragment is administered as a sustained release composition.