Canopus BioPharma, Inc. (OTC: CBIA), is pleased to announce that the South African Medicines Control Council has granted approval for a Phase II study in 30 cancer patients evaluating the protective effect of CB1400 on the gastrointestinal tract from radiation-induced mucositis. This new trial is an important step forward in the development of CB1400 as a novel, preventative, anti-mucositis agent. Oral and gastrointestinal (GI) mucositis is a painful, debilitating, and sometimes fatal side-effect of radiation therapy and cancer chemotherapy. No preventative mucositis medicines are available, and few treatments are effective. With some cancer therapies, oral mucositis can develop in over 90% of patients. Consequently, it is a widespread problem with considerable economic and healthcare implications. There is a real need for an effective and well-tolerated mucositis prophylactic. The United States market for a preventative mucositis agent is estimated to be over $1 billion per annum. In work carried out on behalf of Canopus, CB1400 has already been shown to have protective and antimutagenic effects when tested in an animal model of mucositis. Complete protection of the GI tract was seen in gamma-radiated mice pre-treated with oral CB1400 (100mg/kg/day). Even with high doses of radiation (10Gy), there was no evidence of mucositis: weight gain was observed in the CB1400 pre-treated groups; all mice treated with placebo died. Canopus has applied to undertake further clinical studies with leading oncologists in Australia, South Africa and the U.S., investigating CB1400 as a preventative mucositis agent in head and neck cancer patients who are receiving radiation and/or chemotherapy. About Canopus BioPharma, Inc.: Canopus BioPharma, Inc. (OTC: CBIA) is dedicated to providing the safest, most cost effective and efficacious pharmaceutical products and assay methods in the areas of infectious disease, radiation protection, cancer, and addiction. With innovative science, proven research and development leadership, and superior products and compounds, Canopus BioPharma has, since 2001, been committed to becoming a market trend setter in a new era of healthcare. In addition, the Company is a world leader in the development of novel camelid antibody products to provide unique avenues of progress and improvement in assay methods and monitoring capabilities for physicians, patients and researchers, particularly for food chain protection applications. Canopus maintains staff in Australia, South Africa, Ireland, Panama and the USA. Additional information on the Company is available at www.canopusbiopharma.com.
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