Background: Immunomax® is a novel immunostimulant manufactured from potato sprouts. It consists of acidic peptidoglycans with a molecular mass of 1,000-40,000 kDa. In order to demonstrate its therapeutic effectiveness and safety, we here present data on the treatment of papilloma virus infections, and two pilot studies on prostatitis and prostate carcinoma treatment. Methods: Immunomax® was investigated using in vitro murine macrophage activation studies and by efficacy studies in human patients suffering from either recurrent anogenital warts caused by papilloma virus, or from chronic prostatitis type IIIa, as determined by the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), or from prostate carcinoma. Results: Immunomax® stimulated nitric oxide (NO) production in murine bone marrow derived macrophages. In human patients, Immunomax® was effective for treating recurrent anogenital warts caused by papilloma virus. Immunomax® therapy also showed, in two pilot studies, a pronounced therapeutic benefit in chronic prostatitis and prostate carcinoma. Patients with chronic prostatitis responded with a significant reduction of leukocytes in exprimate urine, and an increase in quality-of-life as determined by the NIH-CPSI. In case reports on prostate carcinoma, patients responded well to the treatment with a long lasting reduction in prostate-specific antigen. All patients tolerated Immunomax® treatment well without any allergic or undesirable reactions. Conclusions: Immunomax® has been shown to be a novel useful therapeutic agent for the treatment of disorders of the urogenital tract. © 2010 WPMH GmbH.