Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase 2 Study of Oral Talactoferrin in Sev... ( Company also announces Award of a ...)

Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase 2 Study of Oral Talactoferrin in Severe Sepsis

Date:4/22/2008

Company also announces Award of a National Institutes of Health Small Business Innovative Research (SBIR) Grant to support the Phase 2 Trial

HOUSTON, April 22 /PRNewswire/ -- Agennix, Inc. announced today that it has initiated a randomized, double-blind, placebo-controlled Phase 2 study of oral talactoferrin alfa in patients with severe sepsis. 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 2 trial, which has started enrollment, will be conducted at approximately 25 leading U.S. centers with investigators who are very experienced in conducting trials in severe sepsis.

The study is being supported by a Small Business Innovative Research (SBIR) grant awarded from the National Institutes of Health (NIH). 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.

"The number of sepsis-related deaths is on the rise, in spite of available treatment options," said Kalpalatha K. Guntupalli, M.D., Professor of Medicine, Chief of Pulmonary, Critical Care, and Sleep Medicine at Baylor College of Medicine and the Principal Investigator for the Phase 2 study. "Talactoferrin is a very promising compound with broad immunomodulatory and anti-inflammatory properties. The preclinical data in sepsis are very exciting, with talactoferrin demonstrating reductions in mortality rates of 50 percent or more in various animal models. We hope that the preclinical results translate to the drug showing activity in the Phase 2 study by reducing the number of deaths i
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Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase 2 Study of Oral Talactoferrin in Sev...( Company also announces Award of a ...),Health