Compositions and methods relating to reduction of symptoms of autism

• US 6,821,514 B2
• Filed: 12/06/2002
• Issued: 11/23/2004
• Est. Priority Date: 10/01/1999
• Status: Expired due to Term

• Current Assignee: Prothera Incorporated (Soho Flordis International Pty., Ltd.)
• Original Assignee: Prothera Incorporated (Soho Flordis International Pty., Ltd.)
• Inventors: Houston, Devin B.
• Primary Examiner(s): Achutamurthy, Ponnathapura
• Assistant Examiner(s): Moore, William W.
• Application Number:
  US10/313,790
• Publication Number:
  US 20030170227A1
• Time in Patent Office: 718 Days
• Field of Search: 424/64.63, 435/212, 435/225
• US Class Current: 424/94.63
• 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 38/4813 Exopeptidases (3.4.11. to 3.4.19)
• CPC Class Codes: C12N 9/0059 Catechol oxidase (1.10.3.1), i.e. tyrosinase
• CPC Class Codes: C12N 9/48 acting on peptide bonds (3.4)
• CPC Class Codes: C12Y 110/03001 Catechol oxidase (1.10.3.1), i.e. tyrosinase
• CPC Class Codes: C12Y 304/14005 Dipeptidyl-peptidase IV (3.4.14.5)

Abstract

Methods and compositions that can reduce the symptoms of autism in a human patient comprising administering a physiologically effective amount of one or both of a purified casomorphin inhibitor selected from the group consisting of a casomorphinase and a casomorphin ligand, and a physiologically effective amount of a purified gluteomorphin inhibitor selected from the group consisting of a gluteomorphinase and a gluteomorphin ligand, to a human patient in sufficient quantities to reduce the effects of the autism. In some embodiments, the compositions and methods further comprise a physiologically effective amount of an enkephalin inhibitor, preferably an enkephalinase, and a physiologically effective amount of an endorphin inhibitor, preferably an endorphinase.

Claims

1. A composition for reducing symptoms of autism in a human patient comprising a physiologically effective amount of a purified casomorphinase which is a dipeptidyl peptidase, a physiologically effective amount of a purified gluteomorphinase which is a tyrosinase or a phenylalaninase, and at least one of the group consisting of a physiologically acceptable carrier, an adjuvant, an excipient, a buffer and a diluent, wherein the composition is capable of decreasing the incidence of one or more symptoms consisting of eye contact avoidance, failure to socialize, attention deficit, poor mood, hyperactivity, anxiety, stimming, poor comprehension, inappropriate speech, abnormal sound sensitivity, poor digestion, disrupted sleep, and perseveration, and wherein the composition is suitable for oral administration and the decreased incidence is measured relative to the incidence of said one or more symptoms in the untreated individual.

2. The composition of claim 1 wherein the casomorphinase and the gluteomorphinase are not enterically coated.

3. The composition of claim 1 wherein the casomorphinase and the gluteomorphinase are enterically coated.

4. The composition of claim 1 wherein at least one of the group consisting of a physiologically acceptable carrier, an adjuvant, an excipient, a buffer and a diluent comprises maltodextrin, L-lysine, or lactase.

5. The method of claim 1, further comprising at least one non-specific protease.

6. The method of claim 5, further comprising at least one lipase and at least one carbohydratase.

7. The method of claim 6 wherein at least one non-specific protease is papain and the composition additionally comprises at least one further non-specific protease, and at least one carbohydratase is lactase and the composition additionally comprises at least one further carbohydratase.

8. The method of claim 5 wherein at least one non-specific protease is papain and the composition additionally comprises a further non-specific protease.

22. A kit comprising a vessel containing a composition according to claim 1 and instructions directing the use of the composition to reduce the symptoms of autism in a human patient.

23. A vessel containing a composition according to claim 1 and a label comprising instructions directing the use of the composition to reduce the symptoms of autism in a human patient.

9. A method for reducing symptoms of autism in a human patient, comprising orally administering to the patient a composition comprising a physiologically effective amount of a purified casomorphinase which is a dipeptidyl peptidase, a physiologically effective amount of a purified gluteomorphinase which is a tyrosinase or a phenylalaninase, and at least one of the group consisting of a physiologically acceptable carrier, an adjuvant, an excipient, a buffer and a diluent, wherein the composition is capable of decreasing the incidence of one or more symptoms consisting of eye contact avoidance, failure to socialize, attention deficit, poor mood, hyperactivity, anxiety, stimming, poor comprehension, inappropriate speech, abnormal sound sensitivity, poor digestion, disrupted sleep, and perseveration, and wherein the composition is suitable for oral administration and the decreased incidence is measured relative to the incidence of said one or more symptoms in the untreated individual.

10. The method of claim 9 wherein the casomorphinase is a dipeptidyl peptidase IV.

11. The method of claim 9 wherein the casomorphinase and the gluteomorphinase are not enterically coated.

12. The method of claim 10 wherein the casomorphinase and the gluteomorphinase are not enterically coated.

13. The method of claim 9 wherein the casomorphinase and the gluteomorphinase are enterically coated.

14. The method of claim 10 wherein the casomorphinase and the gluteomorphinase are enterically coated.

15. The method of claim 9 wherein at least one of the group consisting of a physiologically acceptable carrier, an adjuvant, an excipient, a buffer and a diluent enhances the oral administration of the composition to a human patient.

16. The method of claim 9 wherein at least one of the group consisting of a physiologically acceptable carrier, an adjuvant, an excipient, a buffer and a diluent comprises maltodextrin, L-lysine, or lactose.

17. The method of claim 9, further comprising at least one non-specific protease.

18. The method of claim 17, further comprising at least one lipase and at least one carbohydratase.

19. The method of claim 18 wherein at least one non-specific protease is papain and the composition additionally comprises at least one further non-specific protease, and at least one carbohydratase is lactase and the composition additionally comprises at least one further carbohydratase.

20. The method of claim 17 wherein at least one non-specific protease is papain and the composition additionally comprises at least one further non-specific protease.

21. A method of manufacturing a medicament for reducing symptoms of autism in a human patient, comprising combining a physiologically effective amount of a purified casomorphinase which is a dipeptidyl peptidase, a physiologically effective amount of a purified gluteomorphinase which is a tyrosinase or a phenylalaninase, and at least one of the group consisting of a physiologically acceptable carrier, an adjuvant, an excipient, a buffer and a diluent, wherein the composition is capable of decreasing the incidence of one or more symptoms consisting of eye contact avoidance, failure to socialize, attention deficit, poor mood, hyperactivity, anxiety, stimming, poor comprehension, inappropriate speech, abnormal sound sensitivity, poor digestion, disrupted sleep, and perseveration, and wherein the composition is suitable for oral administration and the decreased incidence is measured relative to the incidence of said one or more symptoms in the untreated individual.