PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - July 30, 2012) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for patent application US 12/964,327, entitled, "Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases." The patent application covers the use of the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin alfa (talactoferrin) for the treatment of non-small cell lung cancer (NSCLC) and renal cancer in combination with chemotherapy, biotherapy, immunotherapy, surgery, radiotherapy, or a combination thereof.
Torsten Hombeck, Ph.D., Chief Financial Officer and Spokesperson of the Management Board, said: "This patent allowance broadens the coverage of talactoferrin alfa for the treatment of non-small cell lung cancer and renal cancer to include combinations with a wide range of other anti-cancer treatments, such as chemotherapy, biologic therapies and immunotherapies. This is important because it further strengthens our intellectual property position for talactoferrin alfa in areas which we consider priorities for further clinical and commercial development. For example, our Phase III FORTIS-C trial is evaluating talactoferrin alfa in combination with a common chemotherapy regimen, carboplatin/paclitaxel, in first-line non-small cell lung cancer."
Dr. Hombeck continued: "We expect data from our most advanced Phase III trial -- FORTIS-M -- evaluating talactoferrin alfa as a monotherapy in non-small cell lung cancer patients whose disease has progressed following two or more prior treatment regimens in the near future."
About talactoferrin alfa
Talactoferrin alfa is an investigational first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI) currently being studied for the treatment of NSCLC. Oral DCMIs have the potential to harness a patient's own immune system to mount a personal response against his or her cancer. Two randomized, double-blind, placebo-controlled Phase II studies in NSCLC achieved their primary endpoints. In both of these studies, the occurrence of adverse events was statistically significantly lower in the talactoferrin arm compared to the placebo group. Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens, and data from this trial are expected in July/August 2012. 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 AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially lengthen and improve the lives of critically ill patients in areas of major unmet medical need. The Company's most advanced investigational agent is talactoferrin alfa, a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin alfa is currently in Phase III clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, 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, including statements about the timing of clinical trial results. 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 those 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. The achievement of positive results in early stage clinical studies does not ensure that later stage or large scale clinical studies will be successful. 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. Even if the results from the FORTIS-M trial are considered positive, there can be no guarantee that the Company will be able to partner talactoferrin or obtain additional financial resources. 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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