📚 Wiki Antimicrobial & Immune Protegrin

Protegrin

◉ Phase III (completed, failed primary endpoint)
Protegrin-1
Also known as: PG-1, Iseganan, IB-367
Page last reviewed

Quick Summary

Protegrins are disulfide-bridged beta-hairpin antimicrobial peptides isolated from porcine leukocytes. Protegrin-1 (PG-1) is one of the most potent AMPs against both Gram-positive and Gram-negative bacteria, including multidrug-resistant organisms.

Antimicrobial Peptide Phase III (failed)
Protegrins are disulfide-bridged beta-hairpin antimicrobial peptides isolated from porcine leukocytes. Protegrin-1 (PG-1) is one of the most potent AMPs against both Gram-positive and Gram-negative bacteria, including multidrug-resistant organisms. Its synthetic analog Iseganan (IB-367) reached Phase III clinical trials for oral mucositis prevention in cancer patients but failed to meet the primary endpoint.
Storage Stability
Lyophilized
1–2 years (-20°C)
Reconstituted
~30 days (2–8°C)
Room temp
Avoid

Mechanism of Action

Lipopolysaccharide-Triggered Pore Formation

PG-1 binds LPS on Gram-negative bacteria and inserts into the outer membrane. The beta-hairpin structure, stabilized by two disulfide bonds, forms amyloid-like dimers that aggregate into toroidal pores in the inner membrane. The arginine-rich termini provide electrostatic targeting to anionic bacterial membranes. Sub-lethal concentrations cause membrane depolarization and permeabilization, while higher concentrations cause rapid lysis.

Structural Stability Advantage

The beta-hairpin conformation stabilized by disulfide bonds confers protease resistance compared to linear AMPs, extending biological activity. This stability was a key rationale for clinical development. The compact structure also limits immune system recognition.


Research Summary

Broad-Spectrum Potency

Preclinical

PG-1 exhibits MIC values of 0.1-1 ug/mL against E. coli, P. aeruginosa, S. aureus, and C. albicans. Activity against antibiotic-resistant strains including MRSA and VRE is maintained, making it a candidate for last-resort therapeutic development. Structural analogs with altered amino acid composition have been explored to reduce mammalian cell toxicity.

Iseganan Phase III for Oral Mucositis

Phase III (Failed)

Iseganan (IB-367), a protegrin analog, was developed by IntraBiotics Pharmaceuticals for prevention of oral mucositis in cancer patients undergoing radiation and chemotherapy. The Phase III PRISM trial (>600 patients) showed no significant reduction in the primary endpoint of severe oral mucositis. The failure was attributed to complex microbiome interactions and pH variability in the oral cavity affecting drug activity, not fundamental peptide toxicity.


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Research Protocols

GoalDoseFrequencyRoute
Antimicrobial testing (in vitro)0.1-2 ug/mL MICSingle exposureDirect application
Oral mucositis (clinical trial)0.3 mg/mL oral rinseMultiple dailyOral rinse

Clinical dosing from Iseganan Phase III trial. No approved human use.


Interactions

Complex interaction
Oral microbiome
pH and competing flora may reduce efficacy in oral cavity
Potentially synergistic
Conventional antibiotics
Enhanced Gram-negative killing in combination studied

Safety Profile

Topical application was well tolerated in Phase III trials. Systemic hemolytic toxicity limits parenteral use. The beta-hairpin scaffold is being explored to design analogs with improved therapeutic index. No regulatory approval for any indication.


References

  • [1]Lehrer RI, et al. (1993). Protegrins: cysteine-containing antimicrobial peptides from porcine leukocytes. Infect Immun, 61(4), 1433-1442.
  • [2]Trotti A, et al. (2004). Iseganan HCl oral solution for the reduction of severe oral mucositis in patients undergoing radiation therapy for head and neck malignancies. Int J Radiat Oncol Biol Phys, 58(5), 1407-1413.
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Verified Scientific Data Last audited:
Data Sources & External References
Source: peer-reviewed literature  ·  Domain: ascendpeptide.org

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