Agennix AG has announced that data from a Phase II trial in severe sepsis demonstrating the activity and tolerability of talactoferrin, an oral immunotherapy, are being presented this week at the 14th World Conference on Lung Cancer of the International Association for the Study of Lung Cancer (IASLC) in Amsterdam, The Netherlands.
Data from a randomized Phase II study that evaluated 190 patients with severe sepsis who received talactoferrin or placebo are being presented in a poster, "Talactoferrin alfa (TLF) Reduces Mortality across a Broad Range of Patients with Severe Sepsis."
As previously reported, the study met the primary endpoint of reducing 28-day all-cause mortality. Talactoferrin was shown to have an effect across a broad range of patients with different baseline characteristics.
Jeffrey Crawford, M.D., Chief, Division of Medical Oncology, Duke University School of Medicine, said: "Talactoferrin appears to reduce mortality in severe sepsis patients while being well tolerated in this very sick patient population. A Phase II/III trial in patients with severe sepsis has recently been initiated. This could have important implications for subsequent studies in cancer patients, as they are particularly susceptible to developing sepsis since their immune systems are often depressed by the treatments they receive. Cancer patients are also at an increased risk of infection due to frequent hospitalization, surgeries and weakness due to illness. Thus it is important to the cancer care community that effective treatments be found for this condition."
Talactoferrin was very well tolerated in the Phase II study with no significant differences between the two treatment arms in frequency or severity of adverse events. There were no serious adverse events considered to be related to treatment with talactoferrin.
The Phase II trial was primarily funded by a grant from the U.S. National Institutes of Health.