SOURCE: Agennix AG

Agennix AG

July 05, 2011 02:13 ET

Agennix Announces Data From Talactoferrin Phase II Trial in Severe Sepsis Presented at World Conference on Lung Cancer

PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - Jul 5, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) 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.

About talactoferrin
Talactoferrin is an oral immunotherapy that 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 non-small cell lung cancer (NSCLC) and in severe sepsis. Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. A second Phase III trial -- FORTIS-C -- is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. Agennix is also developing talactoferrin for the treatment of severe sepsis and has initiated a Phase II/III trial, called the OASIS trial, in that indication. Talactoferrin has been shown to be very well tolerated in these patient populations.

About Agennix
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 immunotherapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase II studies in non-small cell lung cancer and in severe sepsis. Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer, and a Phase II/III trial with talactoferrin in severe sepsis is underway. 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

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. 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, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and 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.

Agennix™ is a trademark of the Agennix group.

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