• 6/24/2008
  • Los Angeles, CA
  • press release
  • Fox Business (www.foxbusiness.com)

Canopus BioPharma, Inc. 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.