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Immune Regulation


WF10

WF10WF10, a solution of OXO-K993 containing stabilized chlorite ions, appears to act on the macrophage. Normally functioning macrophages - a type of white blood cell that coordinates much of the immune system - can alternate between one of two basic states: phagocytic and inflammatory. Phagocytic macrophages digest invading organisms, such as viruses, and initiate a biological defence pathway. Inflammatory macrophages, in turn, induce a variety of reactions, including fever, sweating, swollen glands, malaise and appetite loss, the common, uncomfortable signs of illness. Such responses, while entirely normal, must be turned on and off in a controlled manner. If left unchecked, pathogens can overdrive the system toward the inflammatory state creating an imbalance that may lead to such medical disorders as chronic inflammation, immune deficiency, organ damage and tumour proliferation.

WF10's proposed mode of activity is based on a theory about how macrophages regulate the immune system. Research suggests that, in some cases, WF10 may rebalance improperly functioning immune systems. The drug has potential applications in adjuvant cancer therapy, diseases related to immune deficiencies, and the management of chronic viral infections.

In 2006, the Company and the University of Heidelberg and the National Centre for Tumor Diseases commenced a Phase 2 trial using oral capecitabine (Xeloda®), a chemotherapeutic drug with WF10 as an adjuvant treatment for inoperable pancreatic cancer. In December 2008, the Company terminated the Phase 2 clinical trial. Preliminary results of an interim analysis indicate that the primary end point, greater than six months survival, was successfully achieved. However, it is unclear, based on the open-label study design and the data reviewed whether the positive results could be confirmed in a placebo controlled study. The Company is continuing to analyze the interim study results, including a more detailed analysis of the Quality of Life data collected during the study.

In September 2009, the Company announced a cooperative drug development project with the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig, Germany and Nuvo subsidiary, Nuvo Research GmbH.  The project is for the preclinical and clinical development of WF10 as a potential treatment for allergic rhinitis.