CB1400 is the dithiolethione molecule, oltipraz (5-[2-pyrazinyl]-4-methyl-1,2-dithiol-3-thione). Canopus BioPharma has confirmed preclinical results which demonstrate oltipraz as an effective agent for the prevention and treatment of oral mucositis, a debilitating side effect of cancer therapy which occurs in over 40% of patients.
Oltipraz reduces the duration and severity of oral mucositis as confirmed in a mucositis hamster model (the most accurate model available)
Oltipraz is applied topically prior to radiation or chemotherapy exposure to prevent the onset of severe mucositis
Oltipraz has previous human clinical use data as an anti-schistosomal and chemopreventive agent, thus providing information on toxicity, pharmacokinetics and potential side effects
Canopus currently has a Phase IIa trial underway in South Africa to examine the effect of oltipraz in the prevention and treatment of mucositis in head and neck cancer patients. Follow-on clinical trials are under preparation in Australia, New Zealand and the USA
The current market size for a drug which would treat and prevent mucositis is conservatively estimated to be in excess of $1 Billion US dollars per annum. Oltipraz is an ideal candidate for oral mucositis, providing patients with a superior alternative to conventional mucositis therapies.
Canopus currently has international patents pending relating to the use of oltipraz (i) as a radioprotective agent and (ii) to prevent and treat oral mucositis. Both of these applications have been entered into the national phase.