The US Patent and Trademark Office (USPTO) has issued notice of allowance for patent application US 12/964,327, entitled, “Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases,” to  Germany-based Agennix AG.

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, PhD, 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 further added, “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.”

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.