Methods and compositions for the treatment of symptoms of prion diseases

• US 9,687,535 B2
• Filed: 05/15/2015
• Issued: 06/27/2017
• Est. Priority Date: 10/03/2008
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): Ariani, Kade
• Application Number:
  US14/713,178
• Publication Number:
  US 20150273030A1
• Time in Patent Office: 774 Days
• Field of Search: None
• 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 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 38/4873 Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
• CPC Class Codes: A61K 38/54 Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
• CPC Class Codes: C12Q 1/37 involving peptidase or proteinase
• CPC Class Codes: C12Y 301/01 Carboxylic ester hydrolases (3.1.1)
• CPC Class Codes: C12Y 302/01 Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
• CPC Class Codes: C12Y 304/00 Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
• CPC Class Codes: C12Y 304/21001 Chymotrypsin (3.4.21.1)
• CPC Class Codes: C12Y 304/21004 Trypsin (3.4.21.4)
• CPC Class Codes: C12Y 304/22002 Papain (3.4.22.2)
• CPC Class Codes: G01N 2333/976 Trypsin; Chymotrypsin
• CPC Class Codes: G01N 2800/2828 Prion diseases
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease

Abstract

A therapeutic composition for the treatment of the symptoms of prion diseases and the method for preparing the therapeutic agents is disclosed. The therapeutic composition is a stable pharmaceutical composition comprising one or more digestive and/or pancreatic enzymes. The therapeutic composition may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic composition may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using fecal chymotrypsin level as a biomarker for the presence of a prion disease, or the likelihood of an individual to develop a prion disease is disclosed.

Claims

1. A method for treating a prion disease in a patient diagnosed with the prion disease, the method comprising administering to the patient a pharmaceutical composition that comprises digestive enzymes, wherein the digestive enzymes comprise a protease, an amylase and a lipase, whereby one or more symptoms of the prion disease are treated;

wherein said patient diagnosed with the prion disease has a subnormal level of fecal chymotrypsin, wherein the one or more symptoms comprise a personality change, a psychiatric problem, lack of coordination, unsteady gait, myoclonus, an unusual sensation, insomnia, confusion, a memory problem, severe mental impairment, loss of the ability to move or speak, or a combination thereof.

2. The method of claim 1, wherein the pharmaceutical composition further comprises one or more enzymes selected from the group consisting of a cellulase, a sucrase, and a maltase.

3. The method of claim 1, wherein the digestive enzymes are pancreatic enzymes.

4. The method of claim 1, wherein the protease is chymotrypsin or trypsin.

5. The method of claim 1, wherein the digestive enzymes are animal enzymes, microbial source enzymes, plant enzymes, or are synthetically prepared enzymes.

6. The method of claim 1, wherein the amylase is present in the pharmaceutical composition in an amount of from about 10,000 to about 60,000 United States Pharmacopeia (U.S.P) units per dose.

7. The method of claim 1, wherein the protease and the lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of from about 1:

1 to about 20;

1.

8. The method of claim 7, wherein the ratio of protease to lipase is from about 4:

1 to about 10;

1.

9. The method of claim 1, wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of a pill, a tablet, a capsule, a microcapsule, a mini-capsule, a time released capsule, a mini-tab, a sprinkle, and a combination thereof.

10. The method of claim 1, wherein the subnormal level of fecal chymotrypsin level is 8.4 U/gram or less.

11. The method of claim 1, wherein the protease is present in the pharmaceutical composition in an amount of from about 10,000 to about 70,000 U.S.P units per dose.

12. The method of claim 1, wherein the lipase is present in the pharmaceutical composition in an amount of from about 4,000 to about 30,000 U.S.P. units per dose.

13. The method of claim 4, wherein the protease is chymotrypsin, and wherein the chymotrypsin is present in the pharmaceutical composition in an amount of from about 2 to about 5 mg per dose.

14. The method of claim 4, wherein the protease is trypsin, and wherein the trypsin is present in the pharmaceutical composition in an amount of from about 60 to about 100 mg per dose.