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CB1400, patented by Canopus BioPharma, enters Phase II clinical trials for the prevention of mucositis in patients with cancer of the head and neck.

LOS ANGELES, CALIFORNIA – Wednesday June 18th 2008 -- 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 gastrointestional 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 US 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 (100 mg/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 BioPharma Inc. has applied to undertake further clinical studies with leading oncologists in Australia, South Africa and the USA, 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. (OTCBB: 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, initially 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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With the exception of historical information contained in this press release, content herein may contain “forward
looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. In particular, the Company may not be successful in its efforts commercialize or attain acceptable clinical results for its products. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts and research and development programs, uncertainties as a result of research and development, consumer and industry acceptance, litigation and/or court proceedings, regulatory risks including approval of Food and Drug Administration filings, the ability to achieve and maintain revenues and profitability in the Company’s business lines, and other factors discussed in the Company's filings with the Securities and Exchange Commission.

 

Contact:
Canopus BioPharma
Len Rothstein, President, 818-980-5008
len@canopusbiopharma.com
Fax: 818-980-5088


Source: Canopus BioPharma, Inc.

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