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Treatment approach is flexible and can be used as a single agent or in combination with chemotherapeutic agents, surgery, and/or radiation therapy.
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Description Cancer is the leading cause of death for individuals aged forty through seventy-nine with more than 1.5 million new US cases in 2010 and 1,500 deaths per day. A continual, compelling need exists for prevention, early detection, prognosis and new treatments to improve patient outcomes and survival rates. The invention is the prophylactic (vaccine) or therapeutic use of human epididymal secretory protein E4 (HE4) in the prevention and treatment of multiple cancers; HE4 protein is a biomarker for cancer, as well as other diseases. Modulation of the HE4 gene and protein expression suppresses growth and proliferation of tumor cells and can be monitored in a single cancer progenitor or stem cell. Treatment approach is flexible and can take the form of HE4 gene delivery therapy, modulation (inhibition, induction, over-expression, conditional activation) of HE4 gene expression, or application of gene products, i.e., mRNA. All can be used as a single agent or in combination with chemotherapeutic agents, surgery, and/or radiation therapy. This specific, targeted HE4 treatment can achieve higher and more effective treatment concentrations with less toxicity and non-specific tissue distribution, in any mammal. HE4 protein is also expressed as a biomarker in many other pathological conditions: inflammatory and autoimmune diseases, renal disorders, and bacterial, fungal, and viral infections. Multiple markets include human and veterinary pharmaceutical and diagnostic, as well as livestock for food consumption.