PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - August 10, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced that the European Patent Office has issued patent number 1507554, entitled, "Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases," covering the use of oral human lactoferrins, including talactoferrin, to treat cancer. It also covers the use of talactoferrin in combination with other therapies, including chemotherapy, immunotherapy, radiation therapy and other treatments. The patent has a term until 2023.
Torsten Hombeck, Ph.D., Spokesperson of the Management Board and Chief Financial Officer, said: "This patent further strengthens our intellectual property position for talactoferrin in the area of oncology. This European patent provides broad protection for talactoferrin in this key market, as it covers the use of human lactoferrin for oral administration, used alone or in combination with other therapies, for the treatment of all cancer types. We also have cancer use patents that were recently issued in the U.S. and Japan, two of the other major markets for talactoferrin, that provide protection until 2025 and 2023, respectively, and include coverage for our lead indication, non-small cell lung cancer."
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.
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 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. 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.