A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy

Giles, Francis J.; Rodríguez, Roberto; Weisdorf, Daniel J.; Wingard, John R.; Martin, Paul J.; Fleming, Thomas R.; Goldberg, Stuart L.; Anaissie, Elias; Bolwell, Brian J.; Chao, Nelson J.; Shea, Thomas C.; Brunvand, Mark M; Vaughan, William P.; Petersen, Finn; Schubert, Mark M.; Lazarus, Hillard M.; Maziarz, Richard T.; Silverman, Margarida; Beveridge, Roy; Redman, Rebecca; Pulliam, Janis; Devitt-Risse, Patricia; Fuchs, Henry J.; Hurd, David D.

doi:10.1016/j.leukres.2003.10.021

Cited by 64 publications

(41 citation statements)

References 37 publications

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“…A second RCT examined the effect of rinsing with iseganan or placebo mouthwash (n=251 in each arm) on OM in a population of mostly HSCT patients, receiving high-dose chemotherapy, with or without total body irradiation (TBI). There was no significant difference between the two arms in OM incidence or severity, peak mouth pain, peak difficulty swallowing, or amount of opioid analgesics used [39]. A separate RCT in H&N cancer patients receiving RT or chemoradiotherapy, compared iseganan (n=253) or placebo mouth rinse (n=171), both in combination with standard oral hygiene, against standard oral hygiene alone (n=87).…”

Section: Isegananmentioning

confidence: 99%

Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the management of oral mucositis in cancer patients

Saunders

Epstein²,

Sharon

et al. 2013

Support Care Cancer

148

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Purpose The aim of this project was to develop clinical practice guidelines on the use of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the prevention and management of oral mucositis (OM) in cancer patients. Methods A systematic review of the available literature was conducted. The body of evidence for the use of each agent, in each setting, was assigned a level of evidence. Based on the evidence level, one of the following three guideline determinations was possible: recommendation, suggestion, or no guideline possible. and doxepin rinse in head and neck radiation therapy (H&N RT) patients. Recommendations were developed against the use of topical antimicrobial agents for the prevention of mucositis. These included recommendations against the use of iseganan for mucositis prevention in HSCT and H&N RT and against the use of antimicrobial lozenges (polymyxintobramycin-amphotericin B lozenges/paste and bacitracinclotrimazole-gentamicin lozenges) for mucositis prevention in H&N RT. Recommendations were developed against the use of the mucosal coating agent sucralfate for the prevention or treatment of chemotherapy-induced or radiation-induced OM. No guidelines were possible for any other agent due to insufficient and/or conflicting evidence. Conclusion Additional well-designed research is needed on prevention and management approaches for OM.

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Section: Isegananmentioning

confidence: 99%

Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the management of oral mucositis in cancer patients

Saunders

Epstein²,

Sharon

et al. 2013

Support Care Cancer

148

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“…Iseganan was originally developed by Intrabiotics Pharmaceuticals Inc. (Mountain View, CA) as a mouth rinse to prevent polymicrobial infection associated with oral mucositis in patients receiving chemotherapy. Based on the pig peptide protegrin (186), 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 (78,248). Intrabiotics subsequently withdrew Iseganan for this indication, but it was entered into trials as an aerosolized treatment for ventilator-associated pneumonia.…”

Section: Development Of Antimicrobial Peptides For Clinical Applicationsmentioning

confidence: 99%

Peptide Antimicrobial Agents

2006

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SUMMARY Antimicrobial host defense peptides are produced by all complex organisms as well as some microbes and have diverse and complex antimicrobial activities. Collectively these peptides demonstrate a broad range of antiviral and antibacterial activities and modes of action, and it is important to distinguish between direct microbicidal and indirect activities against such pathogens. The structural requirements of peptides for antiviral and antibacterial activities are evaluated in light of the diverse set of primary and secondary structures described for host defense peptides. Peptides with antifungal and antiparasitic activities are discussed in less detail, although the broad-spectrum activities of such peptides indicate that they are important host defense molecules. Knowledge regarding the relationship between peptide structure and function as well as their mechanism of action is being applied in the design of antimicrobial peptide variants as potential novel therapeutic agents.

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“…223 A phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of iseganan in the reduction of stomatitis in patients receiving stomatotoxic anticancer chemotherapy. 224 A total of 502 patients were treated with iseganan, 9 mg per dose or placebo, administered as oral rinse six times daily. As outcome of the study, a major impact of iseganan on reducing stomatitis was not detected.…”

mentioning

confidence: 99%

Antimicrobial peptides: The ancient arm of the human immune system

Wiesner¹,

Vilcinskas²

2010

Virulence

619

559

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The production of peptides and small proteins with microbicidal activity collectively called antimicrobial peptides (AMPs) is commonly considered to be a primitive mechanism of immunity and has been extensively studied in insects and other non-vertebrate organisms. In addition, a variety of AMPs present in amphibian skin secretion has been well characterised. There is now increasing evidence that AMPs play a crucial role in human immunity as well. Virtually all human tissues and cells typically exposed to microbes are able to produce AMPs. Important AMPs belonging to two structurally distinct classes, known as the defensins and the cathelicidins, are mainly produced by epithelial cells and neutrophils. AMPs significantly contributing to the chemical skin barrier are represented by dermcidin, psoriasin and RNase 7. The antimicrobial activity of saliva largely depends on histidine-rich AMPs known as histatins. Many more, in part less well-known AMPs and AMP-like proteins exist that exhibit various additional functions, apart from their antimicrobial properties. Among them, the neutrophil granule proteins azurocidin and cathepsin G are members of a family of serine-protease homologues called serprocidins and play a role in the regulation of the immune response and degradation of extracellular matrix proteins respectively. As another AMP-like protein of the neutrophil granule content, bactericidal/permeability increasing protein (BPI) is both able to permeabilise bacterial membranes and to function as an opsonin. The whey acidic protein (WAP) domain containing class of AMPs, including secretory leukocyte protease inhibitor (SLPI), elafin and trappin-2, is equally important in inhibition of neutrophil serine proteases and killing of microbes. Certain CC or CXC chemokines are known to possess antimicrobial properties and therefore are called kinocidins. Several kinocidins, including thrombocidin-1 and -2, are contained in the ?-granules of platelets. A cytoplasmic AMP described as ubiquicidin turned out to be identical with the strongly basic ribosomal protein S30. Proteolytic cleavage of the histone protein H2A in the stomach gives rise to an AMP initially described as buforin I. Adrenomedullin is a hormone-like AMP exhibiting vasodilatory and hypotensive effects. Lysozyme is mainly known for its cell wall degrading activity, but is also capable of non-enzymatic killing of bacteria. An iron-binding protein present in milk and other secretions named lactoferrin was shown to possess antimicrobial and antiviral activity and has been implicated in protection against cancer. Clinical studies on the treatment of infectious diseases have been performed with artificial peptides derived from human lactoferrin, histatins and BPI in addition to porcine protegrins, frog magains and bovine indolicidin. Omiganan, representing an indolicidin derivative, has been demonstrated to be effective in the treatment of acne and catheter-related local infections and is currently considered to be the most promising AMP-based drug candidate

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A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy

Cited by 64 publications

References 37 publications

Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the management of oral mucositis in cancer patients

Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the management of oral mucositis in cancer patients

Peptide Antimicrobial Agents

Antimicrobial peptides: The ancient arm of the human immune system

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