PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - March 23, 2011) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced that the U.S. Patent and Trademark Office has issued patent number 7,901,879, entitled, "Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases." The patent, which has a term until 2025, covers the use of oral human lactoferrins, including talactoferrin, for the treatment of non-small cell lung cancer (NSCLC) and renal cell carcinoma.
Torsten Hombeck, Ph.D., Chief Financial Officer and member of the Company's Management Board, said: "This patent further strengthens our intellectual property position for talactoferrin in a key market and, importantly, covers the use of talactoferrin in its lead indication, non-small cell lung cancer. We are pleased to have recently completed enrollment in the FORTIS-M Phase III registration trial evaluating talactoferrin for this use."
Agennix also reported that a patent application covering the use of talactoferrin in lung cancer has recently received a Decision to Grant in Japan. This patent would provide protection until 2023. The Company has a patent application pending in Europe related to the use of talactoferrin in oncology.
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, as well as 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 also plans to develop talactoferrin further 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 plans to develop this program further 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 talactoferrin will be approved for marketing for non-small cell lung cancer or any other indication in a timely manner, if at all. 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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