IP Library Granted Patent US 9,701,735
Granted Patent B2
US 9,701,735 · App. 13/302,836 · Granted Jul 11, 2017

Compositions and methods for treatment in broad-spectrum, undifferentiated or mixed clinical applications

Inventor: Timothy W. Starzl (Boulder, CO)
Assignee: PANTHERYX, INC.
C07K16/10C07K16/121C07K16/1232C07K16/1282A61K2039/507A61K2039/545A61K2039/70C07K2317/11
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Quick Facts
Patent No.
US 9,701,735
App. No.
13/302,836
Granted
Jul 11, 2017
Kind
B2
Abstract

The disclosure provides improved compositions and methods for passive immunization. In embodiments, a composition comprising a synergistic combination of specific polyclonal antibodies in a carrier matrix is provided. The disclosure provides effective, economical compositions and methods for the treatment of diarrhea and enteric infections in broad-spectrum, undifferentiated, or mixed clinical applications.

Claims (29)

1. A composition for treatment of diarrhea or enteric infection in a non-neonate human in need thereof, the composition comprising:

a non-neonate human effective amount of at least one specific binding molecule, wherein the at least one specific binding molecules comprise a mixture of IgY antibodies specific for antigens derived from Escherichia coli , rotavirus, and coronavirus pathogens, pathogen related toxins, and/or pathogen related adhesion elements; and,

a carrier matrix comprising a matrix obtained from, isolated from, or derived from, non-hyperimmune bovine colostrum,

wherein the human non-neonate effective amount is for the treatment of undifferentiated diarrhea, undifferentiated pediatric diarrhea, traveler's diarrhea, rotavirus diarrhea, toxin-mediated diarrhea, cholera, C. difficile infection, dysentery, typhoid fever, peptic ulcers, or for gastrointestinal flora management.

2. The composition of claim 1 , wherein the carrier matrix comprises full-fat non-hyperimmune bovine colostrum.

3. The composition of claim 1 , wherein the specific binding molecules further comprise IgY specific for an additional human or veterinary, enteric or gastrointestinal, pathogen causing gastroenteritis.

4. The composition of claim 3 , wherein the additional pathogen is selected from the group consisting of: Campylobacter jejuni, Salmonella, Salmonella enterica serovar Typhi, Shigella dystenteriae, Plesiomonas shigelloides , enteropathogenic E. coli , enterotoxigenic E. coli , enteroaggregative E. coli , enteroinvasive E. coli , haemorrhagic E. coli, Clostridium difficile, Yersinia enterocolitica, Vibrio cholerae O1, Vibrio O139, Non-O1 Vibrios, Vibrio parahaemolyticus, Aeromonas hydrophila, Clostridium perfringens , enterohepatic Helicobacter, Helicobacter pylori, Staphylococcus aureus, Klebsiella, Gardnerella spp., Neisseria gonorrhoeae, Chlamydiaceae trachomatis, Mycoplasma spp., Trichomonas vaginalis , herpes virus type 1, herpes virus type 2 , Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis and Candida krusei , Group A Streptococcus spp., norovirus, calicivirus, enteric adenovirus, cytomegalovirus, astrovirus, S. pneumoniae, H. influenzae, Neisseria gonorrhoeae , herpes zoster virus, Fusarium spp., and Acanthamoeba spp.

5. The composition of claim 1 , wherein the specific binding molecules are specific for a pathogen, a pathogen related toxin, or a pathogen related adhesion element, derived from three, four, five, six, seven, or eight, or more, of different pathogenic microorganisms.

6. The composition of claim 1 , wherein the pathogen related toxin comprises an endotoxin or exotoxin.

7. The composition of claim 1 , wherein the pathogen related adhesion element comprises adhesins, cadherins, cilia, fimbrillae, a viral adhesion structure, or a combination thereof.

8. The composition of claim 1 , wherein the carrier matrix consists of full-fat non-hyperimmune bovine colostrum.

9. The composition of claim 1 , wherein the specific binding molecule is in a solid form.

10. The composition of claim 1 , wherein the carrier matrix is in a solid form.

11. The composition of claim 1 further comprising a pharmaceutically acceptable diluent, binder, excipient, lubricant, sweetening agent, flavoring agent, wetting agent, or absorbent.

12. A method for the treatment of diarrhea or enteric infection in a non-neonate human in need thereof; the method comprising administration of a composition comprising:

a) a non-neonate human effective amount of at least one specific binding molecule, wherein the at least one specific binding molecules comprise a mixture of IgY antibodies specific for antigens derived from Escherichia coli , rotavirus, and coronavirus pathogens, pathogen related toxins, and/or pathogen related adhesion elements; and,

b) a carrier matrix comprising a matrix obtained from, isolated from, or derived from, non-hyperimmune bovine colostrum, wherein the non-neonate human effective amount is for the treatment of undifferentiated diarrhea, undifferentiated pediatric diarrhea, traveler's diarrhea, rotavirus diarrhea, toxin-mediated diarrhea, cholera, C. difficile infection, dysentery, typhoid fever, peptic ulcers, or for gastrointestinal flora management.

13. The method of claim 12 , wherein the non-neonate human effective amount is for the treatment of undifferentiated diarrhea, traveler's diarrhea, rotavirus diarrhea, toxin-mediated diarrhea, cholera, and typhoid fever.

14. The method of claim 13 , wherein the undifferentiated diarrhea is pediatric undifferentiated diarrhea.

15. The method of claim 12 , wherein the treatment is used for gastrointestinal flora management.

16. The method of claim 12 , wherein the composition comprises IgY specific for an additional human or veterinary, enteric or gastrointestinal, pathogen causing gastroenteritis selected from the group consisting of: Campylobacter jejuni, Salmonella, Salmonella enterica serovar Typhi, Shigella dystenteriae, Plesiomonas shigelloides , enteropathogenic E. coli , enterotoxigenic E. coli , enteroaggregative E. coli , enteroinvasive E. coli , haemorrhagic E. coli, Clostridium difficile, Yersinia enterocolitica, Vibrio cholerae O1, Vibrio O139, Non-O1 Vibrios, Vibrio parahaemolyticus, Aeromonas hydrophila, Clostridium perfringens , enterohepatic Helicobacter, Helicobacter pylori, Staphylococcus aureus, Klebsiella, Gardnerella spp., Neisseria gonorrhoeae, Chlamydiaceae trachomatis, Mycoplasma spp., Trichomonas vaginalis , herpes virus type 1, herpes virus type 2 , Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis and Candida krusei , Group A Streptococcus spp., norovirus, calicivirus, enteric adenovirus, cytomegalovirus, astrovirus, S. pneumoniae, H influenzae, Neisseria gonorrhoeae , herpes zoster virus, Fusarium spp., and Acanthamoeba spp.

17. The composition of claim 1 , wherein the IgY is obtained from an egg of an immunized chicken.

18. The composition of claim 17 , wherein the IgY is obtained from a whole egg of the immunized chicken.

19. The composition of claim 18 , wherein the IgY antibodies prepared in eggs of hens inoculated with one or a mixture of pathogenic components comprise a mixture of IgY specific for antigens derived from Escherichia coli , rotavirus, coronavirus, Clostridium Perfringens and Salmonella typhimurium pathogens, pathogen related toxins, and/or pathogen related adhesion elements.

20. The composition according to claim. 1 , wherein a single dose comprises from 1-7 g dried immune egg, and 1-7 g dried full-fat non-hyperimmune bovine colostrum.

21. The composition of claim 1 , wherein the composition is in a dried form.

22. The composition of claim 1 , wherein the composition is in a liquid form.

23. The composition of claim 1 , wherein the full-fat non-hyperimmune colostrum is agglomerated and instantized.

24. The method of claim 12 , wherein the carrier matrix comprises full-fat non-hyperimmune bovine colostrum.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Jun 7, 2019
From: PANTHERYX, INC.
To: PERCEPTIVE CREDIT HOLDINGS II, LP
Reel/Frame 049410/0266 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2012
From: STARZL, TIMOTHY W
To: PANTHERYX, INC.
Reel/Frame 027677/0678 →
Continuity (2)
Provisional Application 61416667 · Nov 23, 2010
Related Publication 20120141458A1 · Jun 7, 2012