METHODS AND COMPOSITIONS FOR THE TREATMENT OF SYMPTOMS OF PRION DISEASES
First Claim
1. A method for treating one or more symptoms associated with a prion disease in a patient diagnosed with a prion disease comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising one or more digestive enzymes.
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Accused Products
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.
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Citations
49 Claims
- 1. A method for treating one or more symptoms associated with a prion disease in a patient diagnosed with a prion disease comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising one or more digestive enzymes.
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14. A method of diagnosing a patient comprising:
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obtaining a fecal sample from the patient; determining a level of chymotrypsin present in the fecal sample; and diagnosing the patient as having a prion disease if the determined fecal chymotrypsin level is 8.4 U/gram or less and the patient exhibits at least one symptom associated with. - View Dependent Claims (15, 16, 17, 18, 19, 20)
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21. A method of identifying a patient likely to benefit from administration of a pharmaceutical composition comprising one or more digestive enzymes comprising:
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obtaining a fecal sample from the patient; determining a level of chymotrypsin present in the fecal sample; and identifying the patient as likely to benefit from administration of the pharmaceutical composition if the determined fecal chymotrypsin level is 8.4 U/gram or less and the patient is diagnosed with a prion disease. - View Dependent Claims (22, 23, 24, 25)
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26. A pharmaceutical composition comprising one or more digestive enzymes, wherein the one or more digestive enzymes comprise at least one lipase and at least one protease, and wherein the ratio of total proteases to total lipases (in USP units) ranges from about 1:
- 1 to about 20;
1. - View Dependent Claims (27)
- 1 to about 20;
- 28. A pharmaceutical composition comprising at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, at least one lipase, and papain.
- 31. A pharmaceutical preparation for treating an individual exhibiting one or more symptoms of a prion disease comprising a therapeutically effective amount of a digestive enzyme.
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47. A method of treating an individual having a prion disease with a therapeutically effective amount of digestive enzymes comprising the steps of:
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measuring a level of fecal chymotrypsin in a stool sample of the individual; comparing the level of fecal chymotrypsin with a normal fecal chymotrypsin level; and administering the digestive enzymes to the individual if the level of fecal chymotrypsin in the individual is less than the normal fecal chymotrypsin level. - View Dependent Claims (48, 49)
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Specification