Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Binds bacterium or component thereof or substance produced...
Patent
1995-06-07
1998-04-07
Eisenschenk, Frank C.
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Binds bacterium or component thereof or substance produced...
4241671, 5303891, 5303895, A61K 39395, C07K 1612
Patent
active
057361398
ABSTRACT:
The present provides neutralizing antitoxin directed against C. difficile toxins. These antitoxins are produced in arian species using soluble recombinant C. difficile toxin proteins. The avian antitoxins are designed so as to be orally administrable in therapeutic amounts and may be in any form (i.e., as a solid or in aqueous solution). Solid forms of the antitoxin may comprise an enteric coating. These antitoxins are useful in the treatment of humans and other animals intoxicated with at least one bacterial toxin. The invention further provides vaccines capable of protecting a vaccinated recipient from the morbidity and mortality associated with C. difficile infection. These vaccines are useful for administration to humans and other animals at risk of exposure to C. difficile toxins.
REFERENCES:
patent: 5080895 (1992-01-01), Tokoro
patent: 5196193 (1993-03-01), Carroll
patent: 5268295 (1993-12-01), Serrero
P.H.A. Sneath et al., "Clostridium," in Bergey's Manual.RTM. of Systematic Bacteriology, vol. 2, pp. 1141-1200, Williams & Wilkins (1986).
P.G. Engelkirk et al, "Classification", in Principles and Practice of Clinical Anaerobic Bacteriology, pp. 22-23, Star Publishing Co., Belmont, CA (1992).
J. Stephen and R.A. Petrowski, "Toxins Which Traverse Membranes and Deregulate Cells," in Bacterial Toxins, 2d ed., pp. 66-67, American Society for Microbiology (1986).
R. Berkow and A.J. Fletcher (eds.), "Bacterial Diseases," in Merck Manual of Diagnosis and Therapy, 16th ed., pp. 119-126, Merck Research Laboratories, Rahway, N.J. (1992).
O.H. Sigmund and C.M. Fraser (eds.), "Clostridial Infections," Merck Veterinary Manual, 5th ed., pp. 396-409, Merck & Co., Rahway, N.J. (1979).
C.L. Hatheway, "Toxigenic Clostridia," Clin. Microbiol. Rev. 3:66-98 (1990).
S. Arnon, "Infant Botulism: Anticipating the Second Decade," J. Infect. Dis. 154:201-206 (1986).
S. Arnon, "Infant Botulism," Ann. Rev. Med. 31:541 (1980).
K.L. MacDonald et al., "The Changing Epidemiology of Adult Botulism in the United States," Am. J. Epidemiol. 124:794 (1986).
C.O. Tacket et al., "Equine Antitoxin Use and Other Factors That Predict Outcome in Type A Foodborne Botluism," Am. J. Med. 76:794 (1984).
M.N. Swartz, "Anaerobic Spore-Forming Bacilli: The Clostridia," in Microbiology, B.D. Davis et al., eds., 4th edition, pp. 633-646, J.B. Lippincott Co. (1990).
V.E. Holzer, "Botulismus durch Inhalation," Med. Klin. 41:1735 (1962).
D.R. Franz et al., "Efficacy of Prophylactic and Therapeutic Administration of Antitoxin for Inhalation Botulism," in Botulinum and Tetanus Neurotoxins, B.R. DasGupta, ed., pp. 473-476, Plenum Press, New York (1993).
S. Arnon, "Infant Botulism: Epidemiology and Relation to Sudden Infant Death Syndrome," Epidemiol. Rev. 3:45 (1981).
T.L. Frankovich and S. Arnon, "Clinical Trial of Botulism Immune Globulin for Infant Botulism," West. J. Med. 154:103 (1991).
H. Sugiyama, "Clostridium botulinum Neurotoxin," Microbiol. Rev. 44:419 (1980).
M. Balady, "Botulism Antitoxin Fielded for Operation Desert Storm," USAMRDC Newsletter, p. 6 (1991).
P.J. Schwarz and S.S. Arnon, "Botulism Immune Globulin for Infant Botulism Arrives--One Year and a Gulf War Later," Western J. Med. 156:197 (1992).
D.R. Peterson et al., "The Sudden Infant Death Syndrome and Infant Botulism," Rev. Infect. Dis. 1:630 (1979).
S. Arnon et al., "Intestinal Infection and Toxin Production by Clostridium botulinum as One Cause of Sudden Infant Death Syndrome," Lancet, pp. 1273-1276, Jun. 17, 1978.
G.F. Brooks et al., (eds.) "Infections Caused by Anaerobic Bacteria," Jawetz, Melnick, & Adelberg's Medical Microbiology, 19th ed., pp. 257-262, Appleton & Lange, San Mateo, CA (1991).
Lyerly et al., "Characterization of a Toxin A-Negative, Toxin B-Positive Strain of Clostridium difficile," Infect. Immun. 60:4633 (1992).
Borriello et al., "Virulence Factors of Clostridium difficile," Rev. Infect. Dis., 12(suppl. 2):S185 (1990).
Lyerly et al., "Effects of Clostridium difficile Toxins Given Intragastrically to Animals," Infect. Immun., 47:349 (1985).
Rolfe, "Binding Kinetics of Clostridium difficile Toxins A and B to Intestinal Brush Border Membranes from Infant and Adult Hamsters," Infect. Immun., 59:1223 (1990).
Kim and Rolfe, "The Protective Role of antibody to Toxin A In Clostridium difficile-Induced Ileocecitis," Abstr. Ann. Meet. Am. Soc. Microbiol., 69:62 (1987).
Banno et al., "Biochemical Characterization and Biologic Actions of Two Toxins (D-1 and D-2) from Clostridium difficile," Rev. Infect. Dis., 6(Suppl. 1:S11-S20 (1984).
Rihn et al., "A New Purification Procedure for Clostridium difficile Enterotoxin," Biochem. Biophys. Res. Comm., 124:690-695 (1984).
Justus et al., "Myoelectric Effects of Clostridium difficile: Motility-Altering Factors Distinct From Its Cytotoxin and Enterotoxin in Rabbits," Gastroenterol., 83:836-843 (1982).
S.M. Finegold et al., "Antimicrobial-Associated Pseudomembranous Colitis," in A Clinical Guide to Anaerobic Infections, pp. 88-89, Star Publishing Co., Belmont, CA (1992).
United States Pharmacopeia, vol. XXII (1990) United States Pharmacopeial Convention, Rockville, MD, pp. 1515-1516.
FDA Guidelines for Parenteral Drugs (Dec. 1987); i.e., Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices, Maintained by: Division of Manufacturing and Product Quality (HFN-320), Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD.
21 C.F.R. .sctn..sctn. 660.100-105.
F.C. Perason, Pyrogens: Endotoxins, LAL testing and Depyrogenation, Marcel Dekker, pp. 150-155, New York (1985).
Lyerly et al., "Passive Immunization of Hamsters against Disease Caused by Clostridium difficile by Use of Bovine Immunoglobulin G Concentrate," Infect. Immun. 59:2215 (1991).
H.N. Benson et al., "Requirement of Avian C'l For Fixation of Guinea Pig Complement By Avian Antibody-Antigen Complexes," J. Immunol. 87:616 (1961).
A.A. Benedict and K. Yamaga, "Immunoglobulins and Antibody Production in Avian Species," in Comparative Immunology, J.J. Marchaloni, ed., pp. 335-375, Blackwell, Oxford (1966).
R. Patterson et al., "Antibody Production and Transfer to Egg Yolk in Chickens," J. Immunol. 89:272 (1962).
S.B. Carroll and B.D. Stollar, "Antibodies to Calf Thymus RNA Polymerase II From Egg Yolks of Immunized Hens," J. Biol. Chem. 258:24 (1983).
Polson et al., "Antibodies to Proteins From Yolk of Immunized Hens," Immunol. Comm. 9:495 (1980).
Delmee et al., "Characterization of Flagella of Clostridium difficile and Their Role in Serogrouping Reactions," J. Clin. Microbiol., 28(10):2210 (1990).
Delmee et al., "Virulence of Ten Serogroups of Clostridium difficile in Hamsters," J. Med. Microbiol., 33:85 (1990).
Toma et al., "Serotyping of Clostridium difficile," J. Clin. Microbiol., 26(3):426 (1988).
Delmee et al., "Serogrouping of Clostridium difficile Strains by Slide Agglutination," J. Clin. Microbiol., 21:323 (1985).
Davies et al., "Detection of Capsule in Stains of Clostridium difficile of Varying Virulence and Toxigenicity," Microbial Path., 9:141 (1990).
M.A.C. Edelstein, "Processing Clinical Specimens for Anaerobic Bacteria: Isolation and Identification Procedures," in Bailey and Scott's Diagnostic Microbiology, S.M. Finegold et al (eds.), pp. 477-507, C.V. Mosby Co., (1990).
N.V. Padhye et al., "Production and Characterization of a Monoclonal Antibody Specific for Enterohemorrhagic Escherichia coli of Serotypes O157:H7 and O26:H11," J. Clin. Microbiol. 29:99-103 (1990).
B.R. DasGupta & V. Sathyamoorthy, "Purification and Amino Acid Composition of Type A Botulinum Neurotoxin," Toxicon, 22:415 (1984).
B.R. Singh & B.R. DasGupta, "Molecular Differences Between Type a Botulinum Neurotoxin and is Toxoid," Toxicon, 27:403 (1989).
H. Towbin et al., "Electrophoretic Transfer of Proteins from Polyacrylamide Gels to Nitrocellulose Sheets: Procedure and Some Applications," Proc. Natl. Acad. Sci. USA, 76:4350 (1979).
K. Weber and M. Osborn, "Proteins and Sodium Dodecyl Sulfate: Molecular Weigh
Firca Joseph R.
Kink John A.
Padhye Nisha V.
Stafford Douglas C.
Thalley Bruce S.
Eisenschenk Frank C.
Ochidian Pharmaceuticals, Inc.
LandOfFree
Treatment of Clostridium difficile induced disease does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Treatment of Clostridium difficile induced disease, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Treatment of Clostridium difficile induced disease will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-10364