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发表于 2002-9-4 20:40
hepatitis b drugs watch, for your information
PHASE I PHASE II PHASE III
Drugs are being tested for safety on volunteer test subjects Drugs have passed phase one, and are being tested for dosage and side effects Drugs in Phase III stage are being tested for effectiveness, to determine how well they really work to treat the disease.
FAMILY / DRUG NAME MECHANISM COMPANY* WEBSITE STATUS
Interferons Mimic naturally-occurring, infection-fighting immune substance produced in the body
Interferon alpha2b (Intron A®) Immunomodulator Schering-Plough
Madison, NJ www.schering.com FDA Approved
1991
There are other brands of interferon approved for HCV treatment, but they have not been FDA-approved for HBV: Wellferon® (Glaxo), Roferon® (Hoffman-La Roche), and Infergen® (Amgen)
Nucleoside Analogues - Interfere with the viral DNA polymerase enzyme used for hepatitis B virus reproduction
Lamivudine
(Epivir-HBV®) Inhibits viral DNA polymerase GlaxoSmithKline,RTP, N.C. www.gsk.com FDA Approved
1998
Adefovir Dipivoxil Inhibits viral DNA polymerase Gilead Sciences
Foster City, CA www.gilead.com Phase III
Entecavir Inhibits viral DNA polymerase Bristol-Myers Squibb, Princeton, N.J. www.bms.com Phase III
FTC (Coviracil®) Inhibits viral DNA polymerase Triangle, RTP, N.C. www.tripharm.com Phase III
DAPD (DXG) Inhibits viral DNA polymerase Triangle, RTP, N.C. www.tripharm.com Phase II
L-FMAU (Clevudine®) Inhibits viral DNA polymerase Triangle, RTP, N.C. www.tripharm.com Phase II
AM365 Inhibits viral DNA polymerase Amrad, Victoria, Australia www.amrad.com.au Phase II, Australia & Asia
LdT (Telbivudine) Inhibits viral DNA polymerase Idenix, Boston, MA www.idenix.com Phase III
monval-LdC (Valtorcitabine) Inhibits viral DNA polymerase Idenix, Boston, MA www.idenix.com Phase II
ACH-126,443 (L-Fd4C) Inhibits viral DNA polymerase Achillion New Haven, CT www.achillion.com Phase II (Central & Eastern Europe)
MCC478 Nucleoside analog "prodrug" Eli Lilly & Co.,
Indianapolis, IN www.lilly.com Phase I (Germany)
Racivir (RCV) Inhibits viral DNA polymerase Pharmasset, Tucker, GA www.pharmasset.com IND Filed 5/02
Fluoro-L and D nucleosides Inhibits viral DNA polymerase Pharmasset, Tucker, GA www.pharmasset.com Preclinical
Robustaflavone Inhibits viral DNA polymerase Advanced Life Sciences, Woodbridge IL www.advancedlifesciences.com Preclinical
ICN 2001-3 Inhibits viral DNA polymerase ICN, Costa Mesa, CA www.icnpharm.com Preclinical
Non-Nucleoside Anti-virals - Interfere with proteins involved in viral reproduction
Bam 205 "Small Molecule" Novelos, Newton, MA http://novelos.com Phase II/III China
XTL-001 Human monoclonal antibodies XTL Biopharm, Rehovot, Isreal www.xtlbio.com Phase II, Israel & USA
Imino-Sugars (Nonyl-DNJ) *Discovered by HBF Scientists Protein folding inhibitor Synergy, Edison, N.J. Tel: 732.302.1111 Preclinical
HepBzyme Nuclease resistant ribozyme Ribozyme, Boulder, Co www.rpi.com Preclinical
Non-Interferon Immune Enhancers - Boost T-cell infection-fighting immune cells and natural interferon production
HE2000 NEW Hollis-Eden San Diego, CA www.holliseden.com Phase II, Singapore
Theradigm Immune stimulator Epimmune,
San Diego, CA www.epimmune.com Phase II
EHT899 Oral Viral Protein Enzo Biochem, Inc., New York, N.Y. www.enzo.com Phase II (Israel)
Thymosin alpha-1
(Zadaxin®) Immune stimulator SciClone
San Mateo, CA www.sciclone.com 1. Phase II with Lamivudine
2.Orphan drug approval in USA
HBV DNA Vaccine Immune stimulator PowderJect, Oxford, U.K. www.powderject.com Phase I
HBV DNA Vaccine Immune stimulator Jefferson Center, Doylestown, PA 215.489.4949 Preclinical
HBV Antigen Oral Tolerance OraGen,
Philadelphia, PA 215.923.5124 Preclinical
Post-Exposure and/or Post-Liver Transplant Treatment
BayHep B® HBV Immuneglobulin Bayer U.S.,
Pittsburgh, PA www.bayer.com FDA Approved 1977
Nabi-HB® HBV Immuneglobulin Nabi, Boca Raton, FL www.nabi.com FDA Approved
1999
Anti-hepatitis B HBV Immuneglobulin Cangene, Ontario, Canada www.cagene.com FDA Filing 2001
Hepatitis Vaccine Watch Download a PDF
version of this chart
NAME TYPE VACCINE COMPANY WEBSITE STATUS
Hepatitis B Vaccines - Recommended for those at risk and patients with chronic HCV
Engerix B Recombinant HBV GlaxoSmithKline, Philadelphia, PA www.gskvaccines.com Market, USA
Recombivax HB Recombinant HBV Merck, West Point, PA www.merck.com Market, USA
GenHevac B Recombinant HBV Aventis Pasteur, Lyons, France www.aventispasteur.com Market, Europe
Hepacare
(formerly, Hepagene) HBV preS1, preS2 PowderJect, Oxford, U.K. www.powderject.com Market, Europe
Bio-Hep B HBV S, preS1, PreS2 Biotech. Gen. Corp., Iselin, N.J. www.btgc.com Market, Israel
Hepatitis A Vaccines - Recommended for those at risk and patients with chronic HBV and HCV
Havrix Inactivated HAV GlaxoSmithKline www.gskvaccines.com Market, USA
VAQTA Inactivated HAV Merck www.merck.com Market, USA
Avaxim Inactivated HAV Aventis Pasteur www.aventispasteur.com Market, Europe
Combination Hepatitis Vaccines
TwinRix (Adult) HBV and HAV GlaxoSmithKline www.gskvaccines.com Market, USA
Comvax (Pediatric) HBV and HiB Merck www.merck.com Market, USA
Hexavac (Pediatric) HBV, DTP, HiB, Polio Aventis Pasteur www.aventispasteur.com Market, Europe
Hepatitis Vaccines in Development
Hep B Vaccine ISS-linked to HBsAg Dynavax Technology, Berkley, CA www.dynavax.com Phase I/II
Hep B
DNA Vaccine Px
HBV DNA Vaccine PowderJect www.powderject.com Phase I
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