PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - May 19, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) announced that new data from a Phase II trial evaluating talactoferrin in the treatment of patients with severe sepsis were presented at the American Thoracic Society International Conference in Denver, Colorado. The double-blind, placebo-controlled trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 24 leading centers across the U.S. As previously reported, the Phase II trial achieved its primary endpoint of a reduction in 28-day all-cause mortality (12.5% absolute reduction, 46.5% relative reduction). The analysis presented at the conference evaluated the differences in a variety of cytokines and chemokines (proteins that help to regulate the immune system) in patients receiving talactoferrin versus placebo. The proteins that were measured play an important role in the initiation and propagation of the damaging inflammatory response in severe sepsis. The data were discussed in an oral presentation entitled, "Reduction in Cytokines/Chemokines in Severe Sepsis: Results from a Phase II Randomized Placebo-Controlled Double Blind Trial of Talactoferrin Alfa in Severe Sepsis," given by Kalpalatha Guntupalli, M.D., Professor and Chief, Pulmonary Critical Care and Sleep Medicine, Baylor College of Medicine and principal investigator of the talactoferrin Phase II trial.
Dr. Guntupalli said, "The exploratory analyses we conducted suggest that talactoferrin may be effective in reducing the levels of certain cytokines and chemokines that are important in the initiation and propagation of the inflammatory response in severe sepsis. This provides preliminary evidence of an immunomodulatory effect of talactoferrin in this clinical setting."
Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated promising activity in randomized, double-blind, placebo-controlled Phase II studies in NSCLC and in severe sepsis. Two Phase III trials with talactoferrin in NSCLC are ongoing, and one -- the FORTIS-M trial -- completed enrollment in March 2011. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. Agennix is also continuing the development of talactoferrin for the treatment of severe sepsis and plans to initiate a Phase II/III trial in that indication. Talactoferrin has been shown to be very well tolerated in these patient populations.
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, an oral therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer, as well as in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and Agennix is also continuing the development of this program for the treatment of severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing, and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the Company will move talactoferrin forward in development for severe sepsis in a timely manner, if at all. Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, they may not be sufficient to gain marketing approval in the United States or any other country, and the regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval. In such event, there can be no guarantee that the Company will have or be able to obtain the financial resources to conduct any such additional studies or that such studies will yield results sufficient for approval. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
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