The antimicrobial peptide, Lactoferrin (LF) is a metal binding glycoprotein found in milk, tears, saliva, bronchial, intestinal, and other secretions. Lactoferrin also plays an important role in numerous inflammatory and immune response functions.
This protein displays antimicrobial properties against Gram-positive and Gram-negative bacteria by limiting the availability of environmental iron.
However, since iron-saturated hLF is also able to kill certain bacteria, mechanisms other than iron-depletion apparently are involved in the antibacterial activity of lactoferrin.
AM-Pharma's research has resulted in a first lead, hLF1-11, which consists of the first eleven amino acids of lactoferrin.
Its mechanism of action is predominantly through the intermediacy of cells and/or components of the host as opposed to a direct interaction with the pathogen.
This would explain the extremely low dosages required in vivo and the in vivo efficacy against a broad range of different microbes such as bacteria, fungi, and possibly viruses.
Recent results from Phase I clinical trials in humans showed that hLF1-11 was safe and induced no signs of toxicity, immune responses or other adverse events that could be attributed to the peptide.
Based on these findings hLF1-11 is currently evaluated in a Phase II trial as an effective and safe antibacterial and antifungal substance for the prevention of severe fungal and bacterial infections, especially in patient undergoing bone marrow stem cell transplantations.
"The granting of these patents forms the basis for the development of a novel class of antibiotics for the treatment of systemic infections," said Bruno Giannetti, President & Chief Executive of AM-Pharma.
"AM-Pharma is currently validating additional indications for this lead compound," he added.
In recent years, the threat of infectious diseases has grown tremendously in volume and complexity. Factors contributing to this trend include the growing population of immunocompromised, surgical and intensive-care patients.
The incidence of invasive fungal infections is increasing in many hospitals and Candida species have emerged as the fourth most common cause of bloodstream infections in the US.
Despite the recent introduction of several new antifungals (newer generation azoles and echinocandins), the mortality and morbidity of such infections have not decreased substantially.