Human lactoferrin 1-11

The safety and tolerability of hLF 1-11 given in multiple doses has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal or bacterial disease. These patients are different from healthy volunteers because they have received myeloablative treatment, which not only arrests haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which predispose to infections, which typically occur during the week after transplant. It is therefore essential to know that hLF 1-11 is safe and well tolerated when given during neutropenia and mucosal barrier injury before infections ensue.

This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.