Methods and compositions for the treatment of symptoms of prion diseases

• US 9,061,033 B2
• Filed: 01/09/2013
• Issued: 06/23/2015
• 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:
  US13/737,225
• Publication Number:
  US 20130195833A1
• Time in Patent Office: 895 Days
• Field of Search: None
• US Class Current: 1/1
• 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 one or more symptoms of a prion disease in a patient diagnosed with the prion disease, the method comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition consisting essentially of a mixture of digestive enzymes the mixture comprising at least a protease, an amylase, and a lipase, whereby one or more symptoms of the prion disease is treated;

wherein said patient diagnosed with the prion disease has a subnormal level of fecal chymotrypsin.

2. The method of claim 1, wherein the digestive enzymes further comprise 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, independently, derived from an animal source, a microbial source, or a plant source, or are synthetically prepared.

6. The method of claim 1, wherein the pharmaceutical composition comprises amylase 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 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 patient exhibits one or more symptoms selected from the group consisting of personality changes, psychiatric problems, lack of coordination, unsteady gait, myoclonus, unusual sensations, insomnia, confusion, memory problems, severe mental impairment, loss of the ability to move or speak, and a combination thereof.

10. 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.

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

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

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

14. The method of claim 4, wherein the pharmaceutical composition comprises chymotrypsin in an amount of from about 2 to about 5 mg per dose.

15. The method of claim 4, wherein the pharmaceutical composition comprises trypsin in an amount of from about 60 to about 100 mg per dose.