Safety and efficacy of the neuraminidase inhibitor GG167 in experimental human influenza

JAMA

Volumn 275, Issue 4, 1996, Pages 295-299

  Hayden, Frederick G ^a,d   Treanor, John J ^b   Betts, Robert F ^b   Lobo, Monica ^a   Esinhart, James D ^c   Hussey, Elizabeth K ^c  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^c GLAXOSMITHKLINE   (United States)

^d UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ZANAMIVIR;

ADULT; ANTIVIRAL ACTIVITY; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; INFECTION CONTROL; INFLUENZA; INHALATIONAL DRUG ADMINISTRATION; INTRANASAL DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; VIRUS INHIBITION; VIRUS SHEDDING;

EID: 0030032258     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.275.4.295     Document Type: Article

References (38)

1. Liu C, Air GM. Selection and characterization of a neuraminidase-minus mutant of influenza virus and its rescue by cloned neuraminidase genes. Virology. 1993;194:403-407.
2. Seto JT, Rott R. Functional significance of sialidase during influenza virus multiplication. Virology. 1966;30:731-737.
3. Palese P, Tobita K, Ueda M. Characterization of temperature sensitive influenza virus mutants defective in neuraminidase. Virology. 1974;61:397-410.
4. Palese P, Compans RW. Inhibition of influenza virus replication in tissue culture by 2-deoxy-2,3-dehydro-N-trifluoroacetyl-neuraminic acid (FANA): mechanism of action. J Gen Virol. 1976;33:159-163.
5. Burnet FM. Mucin and mucoids in relation to influenza virus action, IV: inhibition by purified mucoid of infection and haemagglutination with the virus strain WSE. Aust J Exp Biol Med Sci. 1948;26:381-387.
6. Shengqiang LI, Schulman J, Itamura S, Palese P. Glycosylation of neuraminidase determines the neurovirulence of influenza A/WSN/33 virus. J Virol. 1993;67:6667-6673.
7. Schulman JL, Khakpour M, Kilbourne E. Protective effects of specific immunity to viral neuraminidase on influenza virus infections of mice. J Virol. 1968;2:778-786.
8. Webster RG, Reay PA, Laver WG. Protection against lethal influenza with neuraminidase. Virology. 1988;164:230-237.
9. Murphy BR, Kasel JA, Chanock RM. Association of serum anti-neuraminidase antibody with resistance to influenza in man. N Engl J Med. 1972;286:1329-1332.
10. Monto AS, Kendal AP. Effect of neuraminidase antibody of Hong Kong influenza. Lancet. 1973;1: 623-625.
11. Couch RB, Kasel JA, Gerin JL, et al. Induction of partial immunity to influenza by a neuraminidase-specific vaccine. J Infect Dis. 1974;129:411-420.
12. Beutner KR, Chow T, Rubi E, et al. Evaluation of a neuraminidase-specific influenza A virus vaccine in children. J Infect Dis. 1979;140:844-850.
13. Meindl P, Bodo G, Palese P, et al. Inhibition of neuraminidase activity by derivatives of 2-deoxy-2,3-dehydro-N-acetylneuraminic acid (FANA). Virology. 1974;58:457-463.
14. Palese P, Schulman JL. Inhibition of influenza and parainfluenza virus replication in tissue culture by 2-deoxy-2,3-dehydro-N-trifluoroacetylneuraminic acid (FANA). Virology. 1974;59:490-498.
15. Palese P, Schulman JL. Inhibitors of viral neuraminidase as potential antiviral drugs. In: Oxford JS, ed. Chemoprophylaxis and Virus Infections of the Respiratory Tract. Cleveland, Ohio: CRC Press Inc; 1977:189-205.
16. Cohnan PM, Varghese JN, Laver WG. Structure of the catalytic and antigenic sites in influenza virus neuraminidase. Nature. 1983;303:41-44.
17. Varghese JN, Colman PM. Three-dimensional structure of the neuraminidase of influenza virus A/Tokyo/3/67 at 2-2 A resolution. J Mol Biol. 1991; 221:473-486.
18. Varghese JN, McKimm-Breschkin JL, Caldwell JB, et al. The structure of the complex between influenza virus neuraminidase and sialic acid, the viral receptor. Proteins. 1992;14327-332.
19. von Itzstein M, Wu WY, Kok GB, et al. Rational design of potent sialidase-based inhibitors of influenza virus replication. Nature. 1993;363:418-423.
20. Holzer CT, von Itzstein M, Jin B, et al. Inhibition of sialidases from viral, bacterial and mammalian sources by analogues of 2-deoxy-23-didehydro-N-acetylneuraminic acid modified at the C-4 position. Glycoconjugate J. 1993;10:40-44.
21. Woods JM, Bethell RC, Coates JAV, et al. 4-guanidino-2,4-dideoxy-2,3-dehydro-N-acetylneuraminic acid is a highly effective inhibitor both of the sialidase (neuraminidase) and of growth of a wide range of influenza A and B viruses in vitro. Antimicrob Agents Chemother. 1993;37:1473-1479.
22. Hayden FG, Rollins BS, Madren LK. Anti-influenza virus activity of the neuraminidase inhibitor 4-guanidino-Neu5Ac2en in cell culture and in human respiratory epithelium. Antiviral Res. 1994;25:123-131.
23. Thomas GP, Forsyth M, Penn CR, McCauley JW. Inhibition of the growth of influenza viruses in vitro by 4-guanidino-2,4-dideoxy-N-acetylneuraminic acid. Antiviral Res. 1994;24:351-356.
24. Ryan DM, Ticehurst J, Derapsey MH, et al. Inhibition of influenza virus replication in mice by GG167 (4-guanidino-2,4-dideoxy-2,3-dehydro-N-acetylneuraminic acid) is consistent with extracellular activity of viral neuraminidase (sialidase). Antimicrob Agents Chemother. 1994;38:2270-2275.
25. Efthymiopoulos C, Barrington P, Patel J, et al. Pharmacokinetics of the neuraminidase inhibitor 4-guanidino-Neu5Ac2en (GG167) following intravenous, intranasal and inhaled administration in man. In: Program and abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy, American Society for Microbiology, October 4-7, 1994; Orlando, Fla. Abstract H70.
26. Hayden FG, Tunkel AR, Treanor JJ, Betts RF, Allerheiligen S, Harris J. Oral LY217896 for prevention of experimental influenza A virus infection and illness in humans. Antimicrob Agents Chemother. 1994;38:1178-1181.
27. Sears SD, Clements ML. Protective efficacy of low-dose amantadine in adults challenged with wild-type influenza A virus. Antimicrob Agents Chemother. 1987;31:1470-1473.
28. Sperber SJ, PA Levine, DJ Innes, SE Mills, FG Hayden. Tolerance and efficacy of intranasal administration of recombinant serine interferon in healthy adults. J Infect Dis. 1988;158:166-175.
29. Jackson GG, Muldoon RL, Akers LW. Serological evidence for prevention of influenzal infection in volunteers by an anti-influenzal drug adamantanamine hydrochloride. Antimicrob Agents Chemother. 1963;3:703-707.
30. Smorodintsev AA, Zlydnikov DM, Kiseleva AM, Romanov JA, Kazantsev AP, Rumovsky VI. Evaluation of amantadine in artificially induced A2 and B influenza. JAMA. 1970;313:1448-1454.
31. Dawkins AT, Gallager LR, Togo Y, Hornick RB, Harris BA. Studies on induced influenza in man, II: double-blind study designed to assess the prophylactic efficacy of an analogue of amantadine hydrochloride. JAMA. 1968;208:1095-1099.
32. Reuman PD, Bernstein DI, Keefer MC, Young EC, Sherwood JR, Schiff GM. Efficacy and safety of low dosage amantadine hydrochloride as prophylaxis for influenza A. Antiviral Res. 1989;11:27-50.
33. Douglas RG Jr. Prophylaxis and treatment of influenza. N Engl J Med. 1990;322:443-450.
34. Aoki FY, Crawley JCW. Distribution and removal of human serum albumin-technetium 99m instilled intranasally. Br J Clin Pharmacol. 1976;3: 869-878.
35. Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol. 1985;37:294-297.
36. Hayden FG, Gwaltney JM Jr. Viral infections. In: Murray JF, Nadel JA, eds. Textbook of Respiratory Medicine. 2nd ed. Philadelphia, Pa: WB Saunders Co; 1994;1:977-1035.
37. Colman PM. Neuraminidase: enzyme and antigen. In: Krug RM. ed. The Influenza Viruses. New York, NY: Plenum Publishing Corp; 1989:175-218.
38. Liu C, Eichelberger MC, Compans RW, Air GM. Influenza type A virus neuraminidase does not play a role in viral entry, replication, assembly or budding. J Virol. 1995;69:1099-1106.