• DRAMP18059
    • Sequence

    • Sequence Name

    • Iseganan(IB-367)
    • Description

    • a synthetic analogue of Protegrin I (IBL-367),extracted from porcine leukocytes;the pig protegrin derivative
    • Activity

    • Antibacterial, Antifungal
    • Medical use

    • a mouth rinse to prevent polymicrobial infection associated with oral mucositis in patients receiving chemotherapy
    • Stage of Development

    • Phase III(Failure)
    • Comments

    • Based on the pig peptide protegrin,Iseganan possesses broad-spectrum activity in vitro against bacteria and fungi; however, in clinical trials it failed to prevent or reduce oral mucositis compared with a placebo
    • Company

    • Intrabiotics Pharmaceuticals Inc.(Mountain View, CA)
    • Target Organism

      • Gram-positive bacteria:
        Streptococcus salivarius (12) (MIC=0.2-5.0 μg/ml), S. sanguis (14) (MIC=4-64 μg/ml), S. mitis (15) (MIC=2-43 μg/ml), S. mutans (3) (MIC=0.7-1.3 μg/ml), Streptococcus spp. group D (6) (MIC=0.25-4 μg/ml), Streptococcus spp. (16) (MIC=1.3-16 μg/ml), Corynebacterium spp. (5) (MIC=0.13-0.25 μg/ml), Staphylococcus spp. (35) (MIC=0.13-4 μg/ml), Methicillin-resistant S. aureus (MRSA; ATCC 33591) (MIC=4 μg/ml);
      • Gram-negative bacteria:
        Pseudomonas aeruginosa (ATCC 9027) (MIC=2 μg/ml), Moraxella spp. (12) (MIC=0.2-0.8 μg/ml), Neisseria sp. (1) (MIC=8 μg/ml), Haemophilus spp. (15) (MIC=1-8 μg/ml), Acinetobacter calcoaceticus (4) (MIC=0.06-2 μg/ml), Klebsiella pneumoniae (4) (MIC=1-5 μg/ml), Pseudomonas aeruginosa (18) (MIC=1-8 μg/ml), Escherichia coli (5) (MIC=0.25-1 μg/ml), Serratia marcescens (16), (MIC=16-256 μg/ml).
      • Fungi:
        Candida albicans (6) (MIC=4-16 μg/ml).
    • Reference

      • A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leukoc. Res.(2004).(PMID: 15120931)
      • A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. Int. J. Radiat. Oncol. Biol. Phys.(2004)(PMID: 22077420)