Talactoferrin alfa, a recombinant human lactoferrin promotes healing of diabetic neuropathic ulcers: a phase 1/2 clinical study

Thomas E. Lyons, Michael S. Miller, Thomas Serena, Peter Sheehan, Lawrence Lavery, Robert S. Kirsner, David G. Armstrong, Amber Reese, Ernest W. Yankee, Aristidis Veves

Research output: Contribution to journalArticle

41 Scopus citations

Abstract

Background: Talactoferrin alfa, a recombinant form of human lactoferrin, is a novel immunomodulatory protein with demonstrated ulcer healing properties in animal models. Methods: A phase 1/2 clinical study was conducted at 7 clinical sites to determine if talactoferrin can improve wound healing in diabetic patients with foot ulceration. Fifty-five patients with diabetic neuropathic foot ulcers participated in this 2-phase study. In phase 1, groups of 3 patients each received open-label 1%, 2.5%, or 8.5% talactoferrin gel twice daily, in a sequential design, to their ulcer for 30 days. No drug-related adverse events were found at any dose level. Phase 2 was a randomized, placebo-controlled, single-blind study of 2.5% and 8.5% gels, with patients equally divided between the 3 groups. In combination with good wound care, treatment was administered topically twice daily to the ulcers for 12 weeks. The primary endpoint was the incidence of ≥75% healing (relative to baseline size). Results: The study, which in phase 2 was powered to detect a difference between the placebo and combined talactoferrin arms with P < .1, met the primary objective. The groups receiving the 2.5% (n = 15) and 8.5% (n = 15) gels had twice the incidence of ≥75% reduction in ulcer size compared with the placebo group (n = 16): 47%, 53%, and 25%, respectively. On an intent-to-treat basis, the combination of the 2 active groups when compared with the placebo group showed a strong trend toward statistical significance (P = .09). There were no talactoferrin-related adverse events or laboratory abnormalities. Conclusions: Topical talactoferrin appears to be safe and well tolerated and improves healing of diabetic neuropathic ulcers.

Original languageEnglish (US)
Pages (from-to)49-54
Number of pages6
JournalAmerican journal of surgery
Volume193
Issue number1
DOIs
StatePublished - Jan 1 2007

Keywords

  • Diabetes
  • Talactoferrin
  • Wound healing

ASJC Scopus subject areas

  • Surgery

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    Lyons, T. E., Miller, M. S., Serena, T., Sheehan, P., Lavery, L., Kirsner, R. S., Armstrong, D. G., Reese, A., Yankee, E. W., & Veves, A. (2007). Talactoferrin alfa, a recombinant human lactoferrin promotes healing of diabetic neuropathic ulcers: a phase 1/2 clinical study. American journal of surgery, 193(1), 49-54. https://doi.org/10.1016/j.amjsurg.2006.07.010