Agennix initiates Phase II study of sepsis drug

The study is being supported by a Small Business Innovative Research grant awarded from the National Institutes of Health. The total amount of the grant, $3 million, will provide the financial resources necessary to conduct the 190-patient study, which is designed to evaluate the safety and activity of talactoferrin in patients with severe sepsis. Results from the trial are anticipated in mid-2009.

This is the first clinical trial of talactoferrin in sepsis and is based on both the mechanism of action of talactoferrin, and promising preclinical data demonstrating a significant reduction in mortality by talactoferrin in a variety of animal models of sepsis, including some that cause 100% mortality in untreated animals.

The Phase II trial, which has started enrollment, will be conducted at approximately 25 US centers with investigators who are said to be very experienced in conducting trials in severe sepsis.

Kalpalatha Guntupalli, principal investigator for the Phase II study, said: “Talactoferrin is a very promising compound with broad immunomodulatory and anti-inflammatory properties. We hope that the preclinical results translate to the drug showing activity in the Phase II study by reducing the number of deaths in patients with severe sepsis.”